System Troubleshooting Guide - yeec.com · PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution AEROSET® System Troubleshooting Guide 3 94816-107—November

SystemTroubleshooting

Guide

Abbott LaboratoriesAbbott Park, IL 6006494816-107—November 2004

©1998, 2004 Abbott LaboratoriesAEROSET is a Registered Trademark of

Abbott Laboratories

PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL

Not for Customer Distribution

2 AEROSET® System Troubleshooting Guide94816-107—November 2004

NOTES



AEROSET® System Troubleshooting Guide 394816-107—November 2004

Revision Status

Document Control Number(s)

Revision Date Section(s) Revised

Pages Revised and Added

30-0897/R1 9/98 Original Issue Original Issue

30-1762/R2 1/00 All Sections All Pages

94816-101 6/01 All Sections All Pages










Highlights of Changes from Previous AEROSET System Troubleshooting Guide (94819-106)

NOTE: This section is intended as a guide to highlight major and significant changes to this version of the AEROSET System Troubleshooting Guide, Part Number 94816-107. It is NOT intended to be a comprehensive description of all changes to the guide and/or AEROSET System functionality, hardware, and reagent applications.

Overview

• The organization of the Assays/Reagents section of the AEROSET System Troubleshooting Guide was updated; it is now divided into General Information and Assay-specific Information subsections.

1. If troubleshooting information for a specific assay is available, it is listed alphabetically in Assay-specific Information. If an assay-specific subsection does not exist, no additional troubleshooting information is currently available.

2. Previously, some assays, e.g., MULTIGENT® assays, included Assay-specific Questions sections. These Question and Answer sections were expanded and renamed Frequently Asked Questions (FAQ).

• The Question and Answer format of some sections in the Troubleshooting Guide was eliminated, with the exception of assay-specific Frequently Asked Questions (FAQ).

• Procedures to verify Limit of Detection (LOD) and Limit of Quantitation (LOQ) were consolidated into one subsection, Verification Procedures in Assays/Reagents, General Information.

• Assay-specific cross reactivity information for Drugs of Abuse (DOA) assays is now located in Assay-specific Information.




• Some information previously included in the Troubleshooting Guide was eliminated because it duplicated information that is readily available to customers in other secondary labeling, e.g., Abbott Clinical Chemistry Package inserts or the AEROSET System Operations Manual. Major sections that were eliminated include:

1. Specific SmartWash™ parameters

2. Specific method comparison, interference, and limit of detection information for DOA assays

3. Specimen collection requirements for MULTIGENT® assays

Specific Changes and/or New Information

• Mercury warning symbol and information added.

• New information for the C-Reactive Protein and Rheumatoid Factor assays added to Assays/Reagents, Assay-specific Information.

• Information for the MULTIGENT Microalbumin assay added to Assays/Reagents, Assay-specific Information. The chemical reaction for MULTIGENT Microalbumin added to Chemical Reactions for Clinical Chemistry Assays.

• New information for the Specific Proteins assays added to both the Assays/Reagents, General Information and Assays/Reagents, Assay-specific Information sections.

• Product information for Abbott Clinical Chemistry calibrators added.

• A list of applicable assays for each control was added to the Bio-Rad Control Products information table.

• A general Specimen Collection and Handling section was created by consolidating various assay-specific information in the previous Troubleshooting Guide.

• Additional information for the Therapeutic Drug Monitoring (TDM) assays, including Frequently Asked Questions (FAQ), added to Assays/Reagents, General Information.

• CK assay—explanation of issues with FlexRate™ linearity.




• Magnesium assay—new assay-specific information added to describe necessary parameter edits when converting units from mEq/L to mg/dL.

• Software section—new screen graphics with software version 1.03ER000. This includes:

– SYSTEM CONFIGURATION screen

– PAGE SETUP screen (Form 1 and Form 2)

– Log On screens (two)

– Assay Configuration screen, Rerun Rules page

– MAINTENANCE UTILITIES screen, SW Info page

– MAINTENANCE UTILITIES screen, Sampling page

– Pressure Monitor screen

• Updated Unit Configuration screen default settings in System Configuration.




Table of Contents

Revision Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Highlights of Changes from Previous AEROSET System Troubleshooting Guide (94819-106) . . . . . . . . . . . . . . . . . . 4

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Specific Changes and/or New Information . . . . . . . . . . . 5

Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Proprietary Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Pictorial Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Troubleshooting Guide Usage Disclaimers . . . . . . . . . . . . . . 16Master Table of Contents/Index Disclaimer . . . . . . . . . . . . . 17Trademark Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Assays/Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Assay Configuration/Installation . . . . . . . . . . . . . . . . . . . . . 21Drugs of Abuse (DOA) Assays . . . . . . . . . . . . . . . . . . . . . 21

Cutoff Calibrator Values . . . . . . . . . . . . . . . . . . . . . 21Qualitative Assay Configuration . . . . . . . . . . . . . . . 22Print Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Factor Mode—Numeric Results . . . . . . . . . . . . 23Example of Factor Mode—Numeric Results

Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Factor Mode—POS/NEG Results . . . . . . . . . . . 26Example of Factor Mode—POS/NEG Results

Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Absorbance Mode . . . . . . . . . . . . . . . . . . . . . . . 29Example of Absorbance Mode Results

Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31Summary of Print Options . . . . . . . . . . . . . . . . 32

ICT™ Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32I-Index—Calibrator/Control Position 42 . . . . . . . . 32

Biohazardous Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Mercury Warning Symbol . . . . . . . . . . . . . . . . . . . . . . . . 33

Calculated Assay Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Recalculating Calculated Assay Results . . . . . . . . . . . . . 34

Calibration Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Drugs of Abuse (DOA) Assays . . . . . . . . . . . . . . . . . . . . . 35

Ethanol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Qualitative Assays. . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Enzyme Factor Calculation . . . . . . . . . . . . . . . . . . . 37Use Cal Factor From . . . . . . . . . . . . . . . . . . . . . . . . 38




Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39Multiconstituent Calibrator (MCC), LN 1E65 . . . . . . . . .39Product Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

Chemical Reactions for Clinical Chemistry Assays . . . . . . . .42Drugs of Abuse (DOA) Assays . . . . . . . . . . . . . . . . . . . . . . . . .60

Assay Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60Cross Reactivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65Method Comparison . . . . . . . . . . . . . . . . . . . . . . . . . . . .65

MULTIGENT® Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66Manufacturer Information . . . . . . . . . . . . . . . . . . . . . . . .66

Plasma Claims for Gel Barrier Tubes . . . . . . . . . . . . . . . . . . .67Proficiency Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68

AAB Reagent Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68CAP Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69

Serum Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69Urine Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71CSF Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71Immunology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71Therapeutic Drug Monitoring . . . . . . . . . . . . . . . . . .72Urine Drug Testing (Drugs of Abuse) . . . . . . . . . . . .72

Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73Bio-Rad Control Products . . . . . . . . . . . . . . . . . . . . . . . . .73Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . .76

Bio-Rad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76Biochemical Diagnostics, Inc. . . . . . . . . . . . . . . . . . .76

Establishing Quality Control Limits . . . . . . . . . . . . . . . .77Temporary Quality Control Limits . . . . . . . . . . . . . .77Permanent Control Limits . . . . . . . . . . . . . . . . . . . .78Temporary Control Limits Worksheet . . . . . . . . . . .79

Reagent Test Count Tracking . . . . . . . . . . . . . . . . . . . . . . . . .80Reagent Test Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80

Sample Blanking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81Self Blank vs. Non-Self Blank . . . . . . . . . . . . . . . . . . . . . .81

Self Blank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81Non-Self Blank . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81

Sample Interference Indices . . . . . . . . . . . . . . . . . . . . . . . . . .82SmartWash™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

SmartWash (Reagent Carryover) When Moving A and B-Line Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

SmartWash Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . .84SmartWash for Non-Abbott Reagent Applications . . . . . .84

Specific Proteins Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85Imprecision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85Bar Code Read Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . .85Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . . .86




Specimen Collection and Handling . . . . . . . . . . . . . . . . . . . 88Therapeutic Drug Monitoring (TDM) Assays . . . . . . . . . . . . 89

Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89Troubleshooting Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . 89Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . . . 90

Verification Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92Confirming the Limit of Detection (LOD) . . . . . . . 92

Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Limit of Detection for Abbott Assays Data Sheet . . 94Limit of Detection for Abbott Assays Data

Sheet Example . . . . . . . . . . . . . . . . . . . . . . . . . . . 95Confirming the Limit of Quantitation (LOQ) . . . . 96

Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96Limit of Quantitation for Abbott Assays Data

Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98Limit of Quantitation for Abbott Assays Data

Sheet Example . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Assay-specific Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101Acid Phosphatase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Method Comparison . . . . . . . . . . . . . . . . . . . . . . . . . . . 101Albumin BCG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Alkaline Phosphatase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

ALT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104Ammonium Heparin Tube Not Acceptable . . . . . . . . . 104

ALT/AST Activated Versus ALT/AST . . . . . . . . . . . . . . . . . . 104Differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

ALT Activated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104Ammonium Heparin Tube Not Acceptable . . . . . . . . . 104

Amphetamine/Methamphetamine . . . . . . . . . . . . . . . . . . 105Cross Reactivity Testing Performed on the AEROSET

System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105Amylase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Interference Information . . . . . . . . . . . . . . . . . . . . . . . 106Apolipoprotein A1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107Apolipoprotein B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108AST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Ammonium Heparin Tube Not Acceptable . . . . . . . . . 109AST Activated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Ammonium Heparin Tube Not Acceptable . . . . . . . . . 109Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109




Barbiturates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110Cross Reactivity Testing Performed on the AEROSET

System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110Benzodiazepines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112

Cross Reactivity Testing Performed on the AEROSET System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112

Calcium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .114Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . .114

Cannabinoids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115Cross Reactivity Testing Performed on the AEROSET

System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115Troubleshooting Imprecision . . . . . . . . . . . . . . . . . . . . .116

Cocaine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .117Cross Reactivity Testing Performed on the AEROSET

System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .117Complement C3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119

Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119Complement C4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120

Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120C-Reactive Protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .121

Standard Material Recovery . . . . . . . . . . . . . . . . . . . . . .121Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . .121

Creatine Kinase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125Digoxin (MULTIGENT®) . . . . . . . . . . . . . . . . . . . . . . . . . . .125

Spironolactone/Canrenone Interference Results . . . . . .125Cross Reactivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126Sample Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . .127

Direct LDL (MULTIGENT) . . . . . . . . . . . . . . . . . . . . . . . . . .128Sample Storage and Stability . . . . . . . . . . . . . . . . . . . . .128Reagent Storage and Stability . . . . . . . . . . . . . . . . . . . . .128Calibrator Storage and Stability . . . . . . . . . . . . . . . . . . .128Linearity Verifiers (80-5953-00, 2 x 3 mL) . . . . . . . . . . .129Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . .131Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131

Ethanol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132Specificity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132

GGT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132

Haptoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .133Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . .133




Hemoglobin A1c (MULTIGENT®) . . . . . . . . . . . . . . . . . . . . 134Reaction Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134Pretreatment (Hemolysate Preparation) . . . . . . . . . . . . 135Accuracy by Recovery of Standards . . . . . . . . . . . . . . . 136Hemoglobin Denaturant Storage Conditions . . . . . . . 137Sample Mixing (Vortex Mixing vs. Pipet Mixing) . . . . 137

Vortex Mix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137Pipet Mix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Interference Information . . . . . . . . . . . . . . . . . . . . . . . 139Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . . 141

ICT™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143L and H (Reference Range) Result Flags Display with

No Result when Error Log Message 351 or 352 Is Generated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Immunoglobulin A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

Immunoglobulin G . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

Immunoglobulin M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Iron . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148Interference Information . . . . . . . . . . . . . . . . . . . . . . . 148

Magnesium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149Units Conversion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Methadone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151Cross Reactivity Testing Performed on the AEROSET

System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151Microalbumin (MULTIGENT) . . . . . . . . . . . . . . . . . . . . . . . 152

Specimen Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . . 152

Opiates 300 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153Cross Reactivity Testing Performed on the AEROSET

System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153Opiates 2,000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Cross Reactivity Testing Performed on the AEROSET System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Phencyclidine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157Cross Reactivity Testing Performed on the AEROSET

System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157Prealbumin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159Propoxyphene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

Cross Reactivity Testing Performed on the AEROSET System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160




Rheumatoid Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .162Standard Material Recovery . . . . . . . . . . . . . . . . . . . . . .162Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . .163

Total Bilirubin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167

Total Protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167Interference Information . . . . . . . . . . . . . . . . . . . . . . . .167

Transferrin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .168Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . .168

Valproic Acid (MULTIGENT®) . . . . . . . . . . . . . . . . . . . . . . .169Accuracy by Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . .169Interference Information . . . . . . . . . . . . . . . . . . . . . . . .169Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . .170

Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171Color Coding on the AEROSET System . . . . . . . . . . . . . . . .173Exporting Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .174

Exported Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .174Exported Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .174

Host Interface Trace Log . . . . . . . . . . . . . . . . . . . . . . . . . . . .175Observed Problems—Software . . . . . . . . . . . . . . . . . . . . . . .176QUALITY Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .178

Interval QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .178QC Rounding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .178QC Statistics—Decimal Places . . . . . . . . . . . . . . . . . . . .179

Rounding of Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . .180Sample Sequence/Smart Sampling . . . . . . . . . . . . . . . . . . . .180Screen Hierarchy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .181

Action Area of the Main Display . . . . . . . . . . . . . . . . . .181Information Access Area of the Main Display . . . . . . . .182

Screen Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183Main Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183REAGENTS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183REAGENTS (Supply Center Segment) Screen . . . . . . . . .184Reagent Supply Center Segment Details Screen . . . . . . .184DATABASE Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .185Search Dialog Window . . . . . . . . . . . . . . . . . . . . . . . . . .185Patient Demographics Dialog Window . . . . . . . . . . . . .185Print Options Dialog Window—Order List/Loadlist . . .186Order Samples Screen . . . . . . . . . . . . . . . . . . . . . . . . . . .186PAGE SETUP Screen (Form 1) . . . . . . . . . . . . . . . . . . . . .187Form 1 Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .187PAGE SETUP Screen (Form 2) . . . . . . . . . . . . . . . . . . . . .188Define Free Text Screen . . . . . . . . . . . . . . . . . . . . . . . . .188Form 2 Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .189On-line Data Transfer Dialog Window . . . . . . . . . . . . . .189




RESULT Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190RESULT Screen—Viewing Rerun Result . . . . . . . . . . . . 190Reaction Graph Screen—Error Code . . . . . . . . . . . . . . 191Reaction Graph Screen—Rate Assay . . . . . . . . . . . . . . . 191Reaction Graph Screen—End-point Assay . . . . . . . . . . 192Absorbance Data Screen . . . . . . . . . . . . . . . . . . . . . . . . 192DATABASE Screen, Accept Results Dialog Window . . . 192CALIBRATOR/CONTROL Screen . . . . . . . . . . . . . . . . . 193CALIBRATOR/CONTROL Screen—Set 1 . . . . . . . . . . . . 193Position Dialog Window . . . . . . . . . . . . . . . . . . . . . . . . 194CALIBRATION SUMMARY Screen . . . . . . . . . . . . . . . . 194Calibration Details Screen . . . . . . . . . . . . . . . . . . . . . . 195QC SUMMARY Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 195Levey-Jennings Graph Screen . . . . . . . . . . . . . . . . . . . . 196Print Options (QC) Dialog Window . . . . . . . . . . . . . . . 196Levey-Jennings Graph Report . . . . . . . . . . . . . . . . . . . . 197QC Details Dialog Window . . . . . . . . . . . . . . . . . . . . . 197QC Data List Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 197ASSAYS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198ASSAY STATUS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 198Assay Configuration Screen, Outline Page . . . . . . . . . . 199Assay Configuration Screen, Base Page

(End-point Assay) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199Assay Configuration Screen, Base Page (Rate Assay) . . 200Assay Configuration Screen, Calibration Page (Linear

Calibration Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . 200Assay Configuration Screen, SmartWash™ Page . . . . . 201Assay Configuration Screen, Rerun Rules Page . . . . . . 201RUN OPTIONS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 202SYSTEM CONFIGURATION Screen . . . . . . . . . . . . . . . . 202SELECT ASSAYS FOR STAT Screen . . . . . . . . . . . . . . . . . 203Pause Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203Unpause Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204START UP OPTIONS Screen . . . . . . . . . . . . . . . . . . . . . 204SHUTDOWN OPTIONS Screen . . . . . . . . . . . . . . . . . . . 205ERROR LOG Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205MAINTENANCE UTILITIES Screen, System Page . . . . . 206MAINTENANCE UTILITIES Screen, SCC Page . . . . . . . 206MAINTENANCE UTILITIES Screen, Sampling Page . . . 207Pressure Monitor Screen . . . . . . . . . . . . . . . . . . . . . . . . 207MAINTENANCE UTILITIES Screen, Rgt Area 1 Page . . 208MAINTENANCE UTILITIES Screen, Rgt Area 2 Page . . 208MAINTENANCE UTILITIES Screen, Rxn Area Page . . . 209Cuvette Blank Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 209Cuvette Integrity Check Screen . . . . . . . . . . . . . . . . . . 210




MAINTENANCE UTILITIES Screen, SW Info Page . . . . .210Printer A Configuration Window . . . . . . . . . . . . . . . . . .210ONLINE (HOST) CONFIGURATION Dialog Window . .211Run Progress Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .211Log On Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .211User Alert Dialog Window . . . . . . . . . . . . . . . . . . . . . . .211

System Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .212FAC Limit % Field—Configuration . . . . . . . . . . . . . . . .212System Configuration Software Disk v3.0 . . . . . . . . . . .213Unit Configuration Default Screen . . . . . . . . . . . . . . . .215

Unit Configuration Screen, Default View Page 2 (Software Version 1.03ER000) . . . . . . . . . . . . . . .216

Startup/Shutdown Setting Default Screens . . . . . . . . . .217User Codes/Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . .219

Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221CPU Used with the AEROSET System . . . . . . . . . . . . . . . . .223Cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .225

Cuvette Volumes—Minimum and Maximum . . . . . . . .225Cuvette Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .225Cuvette Identification . . . . . . . . . . . . . . . . . . . . . . . . . .225

GPIB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .226ICT™ Warranty Information . . . . . . . . . . . . . . . . . . . . . . . .226Noise Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .226Observed Problems—Hardware . . . . . . . . . . . . . . . . . . . . . .227Serial Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .230Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .231

Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .231USP Purified and WFI Requirements . . . . . . . . . . .231

Verification Procedures/Adjustments/Alignments . . . . . . .232Lamp Gain and A/D Check . . . . . . . . . . . . . . . . . . . . . .232

Materials Required . . . . . . . . . . . . . . . . . . . . . . . . .232Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .232

Reagent Arm Adjustment . . . . . . . . . . . . . . . . . . . . . . . .234Materials Required . . . . . . . . . . . . . . . . . . . . . . . . .234R1A Probe Horizontal Adjustment . . . . . . . . . . . . .234Reagent Carousel Alignment . . . . . . . . . . . . . . . . .237R1A Probe Cuvette Alignment . . . . . . . . . . . . . . . .239R1A Probe Wash Cup Alignment . . . . . . . . . . . . . .242




Troubleshooting Flowcharts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .245Abbott Assay—Basic Assay Troubleshooting . . . . . . . . . . . 247

Assay Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 248Instrument Troubleshooting . . . . . . . . . . . . . . . . . . . . 248

Non-Abbott Assay—Basic Assay Troubleshooting . . . . . . . 250Confirmation of Assay Parameter Settings (Illegal Configuration) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251

Erratic Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253QC Out of Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254Calibration Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257ICT™ Failed Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . 259Bubbles in ICT Module Tubing . . . . . . . . . . . . . . . . . . . . . 261LIS/Communication Problems . . . . . . . . . . . . . . . . . . . . . . 262Water Issue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264




Proprietary StatementCopyright 1998, 2004, Abbott Laboratories, Abbott Park, Illinois. All rights reserved. No part of this document may be reproduced, stored, or transmitted in any form or by any means electronic, mechanical, photocopied, recorded, or otherwise without the prior written permission of Abbott Laboratories.

Pictorial DisclaimerAll samples (printouts, graphics, displays, screens, etc.) contained in the AEROSET System Troubleshooting Guide are for information and illustration purposes only and shall not be used for clinical or maintenance evaluations. Data shown in sample printouts and screens do not reflect actual patient names or test results. Abbott Laboratories makes no representations or warranties about the accuracy and reliability of the information in the graphics.

Troubleshooting Guide Usage DisclaimersInformation contained in this document was developed for use by trained Abbott Laboratories Field Service personnel, or by other persons knowledgeable or experienced with operation and service of the AEROSET System. The information should be used under direct supervision and cooperation with Abbott Laboratories technical sales and service representatives.

In no event shall Abbott Laboratories or its affiliates be liable for any damages or losses incurred in connection with, or arising from use of information in this document by persons not fully trained by Abbott Laboratories as technical sales and service representatives. This limitation shall not apply to those persons knowledgeable or experienced with operation and service of the AEROSET System, who use this information under direct supervision of Abbott Laboratories technical sales and service representatives.

Any product information in this guide should be used in conjunction with the latest version of the AEROSET System Operations Manual, Operations Manual Addendum, or Product Information Letter. If any discrepancies in information exist within this guide or any other, the latest version of the Operations Manual, Operations Manual Addendum, or Product Information Letter takes precedence.




Master Table of Contents/Index DisclaimerIncremental manual updates may cause the Master Table of Contents or Master Index page numbering to change.

Trademark StatementsAll Abbott Laboratories product names and trademarks are owned by or licensed to Abbott Laboratories, its subsidiaries, or affiliates. No use of any Abbott trademark, trade name, trade dress, or product name may be made without the prior written authorization of Abbott Laboratories, except to identify the product or services of Abbott Laboratories. All other trademarks, brands, product names, and trade names are the property of their respective companies. All rights reserved.

Except as permitted above, no license or right, express or implied, is granted to any person under any patent, trademark, or other proprietary right of Abbott Laboratories.

c 8000, AEROSET, ARCHITECT, AxSYM, IMx, MULTIGENT, Nembutal, and TDx are registered trademarks of Abbott Laboratories.

FastTrack, FlexRate, ICT, and SmartWash are trademarks of Abbott Laboratories.




NOTES


Assays/Reagents

Assays/Reagents


Assays/Reagents Not for Customer Distribution


NOTES




General Information

Assay Configuration/InstallationRefer to the most current version of Technical Bulletin 1018-2003 when installing new assays.

Drugs of Abuse (DOA) Assays

The Abbott Clinical Chemistry Drugs of Abuse (DOA) menu includes Amphetamine/Methamphetamine, Barbiturates, Benzodiazepines, Cannabinoids, Cocaine, Ethanol, Methadone, Opiates, Phencyclidine, and Propoxyphene.

Cutoff Calibrator Values

Cutoff calibrator levels used for each of the qualitative DOA assays are listed in the following table.

* Cutoff concentrations mandated by SAMHSA (Substance Abuse and Mental Health Services Administration) for Federal Workplace drug testing.

The Ethanol assay is a quantitative assay which is calibrated using two levels of calibrator, 0 mg/dL and 100 mg/dL.

Assay Level

Amphetamine/Methamphetamine 1,000 ng/mL*

Barbiturates 200 ng/mL

Benzodiazepines 200 ng/mL

Cocaine 300 ng/mL*

Cannabinoids (THC50) 50 ng/mL*

Methadone 300 ng/mL

Opiates 300 300 ng/mL

Opiates 2,000 2,000 ng/mL*

Phencyclidine (PCP) 25 ng/mL*

Propoxyphene 300 ng/mL




Qualitative Assay Configuration

Use the following instructions to configure a qualitative assay in Absorbance mode.

1. Select <Assays> in the Information Access Area of the Main Display.

2. Select the desired assay button. The ASSAY STATUS screen displays.

3. Select <Config> in the right column of the screen. The Assay Configuration screen displays.

4. The Outline page is the default view.

5. Verify Quantitative Ranges is selected. This is the default setting.

6. Edit the L-Reference field from “-9999” to “0.0”.

7. Select the Calibration tab to access the Calibration page.

8. Select the list box icon next to the Calib Mode field. Select <Abs> then select the return arrow to close the list.

9. Select <OK>.

Refer to Print Options, Absorbance Mode in this section for additional information.


Not for Customer Distribution Assays/Reagents


Print Options

Results for the Drugs of Abuse (DOA) assays can be printed using one of the following options:

• Factor Mode—Numeric Results

• Factor Mode—POS/NEG Results

• Absorbance Mode

Factor Mode—Numeric ResultsWhen the system is selected for Quantitative Ranges on the Outline page of the Assay Configuration screen, results print a positive number for a value equal to or higher than the Multi DOA Cutoff calibrator, and a negative number for a value lower than the Multi DOA Cutoff calibrator. A positive number is interpreted as positive; the specimen contains drug. A negative number is interpreted as negative; the specimen does not contain drug, or drug present yields a response less than that of the cutoff concentration for the assay being tested.

NOTE: Positive and negative numeric response values do not represent drug concentrations.

Perform the following steps to configure an assay in Factor mode—Numeric.

1. Select <Assays> in the Information Access Area of the Main Display. The ASSAYS screen displays.







Figure 1: Assay Configuration Screen, Outline Page

5. Verify Quantitative Ranges is selected (�). This is the default setting.


Figure 2: Assay Configuration Screen, Calibration Page

7. Verify the Factor option is selected in the Calib Mode field.

8. Verify 1000 is entered in the Factor field.

9. Select <OK> in the upper-right corner of the Assay Configuration screen. The Save dialog window displays.

10. Select <OK> to save the settings.

11. Repeat steps 1 through 10 for each DOA assay installed.

Select

Factor




Example of Factor Mode—Numeric Results Printout

The Barbiturates assay in this example would be reported as positive.

Phencyclidine, Propoxyphene, Opiates 300, Methadone, Amphetamine/Methamphetamine, Cocaine, and Benzodiazepines would be reported as negative.

10/17/01 13:01 SN A7602220SID 007Name John DoePOS 5 ( 2) PIDDate/Time Run 10/17/01 13:01

ERR NAME L/H RESULT ERR NAME L/H RESULTPCP - 30 AmpM - 36Prpx - 52 Coc - 16Opi3 - 17 Benz - 24Meth - 30 Barb H 10




Factor Mode—POS/NEG ResultsWhen the system is configured for Qualitative Ranges, results print as POS for a value equal to or higher than the Multi DOA Cutoff calibrator, and NEG for a value lower than the Multi DOA Cutoff calibrator. A POS result is interpreted as positive; the specimen contains drug. A NEG result is interpreted as negative; the specimen does not contain drug or drugs are present in concentrations below the cutoff level for the assay being tested.

Perform the following steps to configure an assay in Factor mode.






5. Quantitative Ranges is the default setting. Select the checkbox (�) next to Qualitative Ranges.

Select






7. Verify the Factor option is selected in the Calib Mode field.

8. Verify 1000 is entered in the Factor field.

9. Select <OK> in the upper-right corner of the Assay Configuration screen. The Save dialog window displays.



Factor




Example of Factor Mode—POS/NEG Results Printout

The Barbiturates assay in this example would be reported as positive.

Phencyclidine, Propoxyphene, Opiates 300, Methadone, Amphetamine/Methamphetamine, Cocaine, and Benzodiazepines would be reported as negative.

NOTE: A result of “0” would be reported as a positive result.


ERR NAME L/H RESULT ERR NAME L/H RESULTPCP NEG AmpM NEGPrpx NEG Coc NEGOpi3 NEG Benz NEGMeth NEG Barb POS




Absorbance ModeWhen the system is in Absorbance mode, results print as absorbance values. A result equal to or higher than the Multi DOA Cutoff calibrator absorbance is considered positive for the assay tested and negative for a value lower than the Multi DOA Cutoff calibrator absorbance.

Perform the following steps to configure an assay in Absorbance mode.






5. Verify Quantitative Ranges is selected (�). This is the default setting.

6. Edit the L-Reference field from “-9999” to “0.0”.

Select






8. Select the list box icon next to the Calib Mode field. Select <Abs> then select the return arrow to close the list.

9. Select <OK> in the upper right corner of the Assay Configuration screen. The Save dialog window displays.



Abs




Example of Absorbance Mode Results Printout

Each assay value in this example would be compared to its cutoff calibrator absorbance to determine if the result is positive or negative.

The following are examples only and do not demonstrate actual absorbance values.

The Barbiturates and Cannabinoids (THC50) assays in this example would be reported as positive.

Amphetamine/Methamphetamine, Benzodiazepines, Cocaine, Methadone, Opiates 300, Opiates 2,000, Phencyclidine, and Propoxyphene would be reported as negative.


ERR NAME L/H RESULT ERR NAME L/H RESULTPCP 0.3237 AmpM 0.2776Prpx 0.3870 Coc 0.3212Opi3 0.2341 Benz 0.2702Meth 0.3988 Barb 0.2926

Assay Sample Absorbance

Cutoff Absorbance Result

Amphetamine/Methamphetamine

0.2776 0.2778 Negative

Barbiturates 0.2926 0.2923 Positive

Benzodiazepines 0.2702 0.2705 Negative

Cannabinoids 50 0.3206 0.3206 Positive

Cocaine 0.3212 0.3232 Negative

Methadone 0.3988 0.3989 Negative

Opiates 300 0.2341 0.2378 Negative

Opiates 2,000 0.2781 0.2789 Negative

Phencyclidine 0.3237 0.3286 Negative

Propoxyphene 0.3870 0.3889 Negative




Summary of Print OptionsThe following table summarizes the three print options for the DOA assays.

NOTE: For troubleshooting purposes, Absorbance mode is recommended.

ICT™ Configuration

I-Index—Calibrator/Control Position 42

I-Index is not currently used, but Calibrator/Control position 42 (I-Index) must have a concentration of zero defined for all ICT assays. If the concentrations are not defined:

• ICT buttons do not display on the SELECT ASSAYS FOR CALIBRATION screen.

• Calibration Summary report does not print the ICT Cal L values.

Print Options Description of Results Outline Page Configuration

Calibration Page Configuration

Factor Mode— Numeric Results

Positive or negative numbers will print; numbers are relative to the cutoff calibrator and do not represent actual concentration.

Select Quantitative Ranges

Calib Mode = FactorFactor = 1,000

Factor Mode—POS/NEG Results

Results will print POS or NEG relative to the cutoff calibrator.

Select Qualitative Ranges

Calib Mode = FactorFactor = 1,000

Absorbance Mode Results will print as absorbance values; results should be interpreted as positive or negative relative to the absorbance of the cutoff calibrator.

Select Quantitative RangesEdit the L-Reference field to 0.0

Calib Mode = Abs




Biohazardous WasteBoth high and low-concentration waste contain reagent and sample and should be considered biohazardous.

Studies of the combined waste streams have shown the pH typically ranges from 5.5 to 7.

Dispose of waste in accordance with appropriate waste disposal regulations.

For additional environmental, health, and safety information, refer to Section 8, Hazards of the AEROSET System Operations Manual and the product-specific package insert.

Mercury Warning Symbol.

Because mercury is a persistent and toxic pollutant that bioaccumulates in the environment, several states have enacted legislation which impacts the marketing and labeling of products containing mercury or Thimerosal. Therefore, the above symbol was added to the following Abbott Clinical Chemistry products’ labeling due to mercury content.

• Albumin BCG

• Bilirubin Calibrators

• Urine/CSF Protein Calibrators




Calculated Assay Results

Recalculating Calculated Assay Results

The assays included in a calculated assay must be performed during the same run for the calculation to take place. The result is calculated with the original assay results and does not automatically recalculate with an assay’s rerun data.

If a retest is necessary for one of the assays of a calculated result, retest all the assays included in the calculated result.

Use the following instructions to move an assay’s rerun data to the original data, and to perform recalculation of the ratio.

1. On the DATABASE screen, select the rerun sample (rerun sample has the Processing Code “L”).

2. Select <Result> in the right column of the DATABASE screen. The RESULT screen displays.

3. Display the desired rerun result.

4. Select <Select> in the right column of the RESULT screen.

5. Select <OK> on the Select Result dialog window. An “S” displays to the left of the assay name and the rerun result is copied over the original result for this assay.

6. Select <OK> to exit the RESULT screen.

7. On the DATABASE screen, select the original sample result.

8. Select <ReCalc> in the right column. The Recalc dialog window displays.

9. Select <Select Assay> then select the ratio to be recalculated on the SELECT ASSAYS screen.

10. Select <OK>. The ratio is calculated from the rerun assay data.




Calibration Information

Drugs of Abuse (DOA) Assays

Ethanol

The Ethanol assay is a quantitative assay and uses the Ethanol 0 and 100 calibrators.

Qualitative Assays

Calibration of the qualitative DOA assays is performed by running the calibrators in duplicate. The Multi DOA Cutoff calibrator is configured as “0” (zero) in the Target Value field of the CALIBRATOR/CONTROL screen for the Amphetamine/Methamphetamine, Barbiturates, Benzodiazepines, Cannabinoids (THC50), Cocaine, Methadone, Opiates 2,000, Phencyclidine, and Propoxyphene assays. The Opiates 300 calibrator is configured as “0” (zero) for the Opiates 300 assay.

For Amphetamine/Methamphetamine, Barbiturates, Benzodiazepines, Cannabinoids (THC50), Cocaine, Methadone, Opiates 300, Opiates 2,000, Phencyclidine, and Propoxyphene assays, any result value equal to or greater than the Multi DOA Cutoff calibrator is positive; the specimen contains drug. Any result below the cutoff level for the assay being tested is interpreted as negative; the specimen does not contain drug, or drugs present yield a response less than that of the cutoff calibrator for the assay being tested.

The calibration is verified by running Multi DOA Verifiers I and II (recommended) and controls. Two levels of controls should also be run, with one control level 25% above the cutoff concentration and the other control level 25% below the cutoff concentration. Verifiers I and II and control results should show appropriate responses relative to one another, as shown:

Verifier I < – 25% Control < Cutoff Calibrator < + 25% Control < Verifier II




If any trends or sudden shifts in value of the verifiers occur, check the assay reagent cartridge for onboard dating and reagent expiration date. If necessary, replace the reagent cartridge and repeat calibration.

NOTE: The Opiates 300 calibrator contains methamphetamine. This does not interfere with the Opiates 300 assay.

Refer to the assay-specific package inserts for additional information on calibration, verifiers, and controls.

Assay DrugMulti DOA Verifier Ing/mL

Opiates 300 Calng/mL

Multi DOA Cutoff Cal

ng/mL

Multi DOA Verifier II

ng/mL

Amphetamine/ Methamphetamine

d-Methamphetamine 0 300 1,000 2,000

Barbiturates Secobarbital 0 200 800

Benzodiazepines Lormetazepam 0 200 1,000

Cannabinoids 11-nor-∆9-THC-9-COOH

0 50 200

Cocaine Benzoylecgonine 0 300 1,000

Methadone Methadone 0 300 1,000

Opiates Morphine 0 300 2,000 4,000

Phencyclidine Phencyclidine 0 25 100

Propoxyphene Propoxyphene 0 300 1,000




Factor

The Factor option only displays if Factor is selected as the calibration mode. This method allows the operator to enter the factor used to calculate the result as a concentration.

The Factor math model can be used for any reaction that is linear and stable across all reagent lots. The calibration factor is defined at a fixed value and only the reagent blank is performed for calibration. No calibrators are required. It is ideal for use in measuring enzyme activity in a sample, because the enzyme reaction occurs at a predictable and steady rate that can be determined for the chromophore, wavelengths, and volume parameters used.

Enzyme Factor Calculation

The following formula is used to calculate enzyme factors.

Where:

Total Volume

Reagent 1 volume + Reagent 1 water volume + Reagent 2 volume + Reagent 2 water volume + Sample volume

(Extinction factor) established by measuring varying concentrations of the chromophore (NADH, PNP, etc.) on the system. The slope of the linear regression of the measured absorbance versus the concentration equals the extinction factor. The factor is specific for the AEROSET and c 8000® Systems, and optical characteristics of these systems.

Enzyme Factor

Entered in the Factor field on the Calibration page of the Assay Configuration screen.

TotalaVolumeaxa1000SampleaVolume

a1aε

a EnzymeaFactor=




*3-carboxy-4-nitroaniline

Use Cal Factor From

Use Cal Factor From option only displays if Use Factor/Blank is selected as the calibration mode. This method allows the operator to enter the name of the assay from which the calibration data are used.

This list includes all the assays configured on the system.

This method may be used when two assays use the same reagent and have the same sample-to-reagent volume ratios. Rather than calibrating both assays, only one of the assays is calibrated and the other assay is configured to refer to this calibration data for result calculation. For example, a urine application of an assay may use the calibration data generated for the serum application for the same assay, e.g., urine Amylase.

The assay selected as the reference assay must generate its own curve and cannot also be defined with the Use Factor/Blank calibration mode.

Assay Chromophore WavelengthTotal

Volume µL

Sample Volume

µL

Extinction Factor

Enzyme Factor

Acid Phosphatase

Alpha-naphthol-Fast

Red TR complex

412/660 162.0 12.0 12.9 1046.5

Alkaline Phosphatase

PNP 404/476 257.0 7.0 17.08 2150

Amylase CNP 404/476 204.8 4.8 12.44 3431

ALT NADH 340/380 205.3 5.3 4.76 8141

ALT Activated NADH 340/380 178.7 3.7 4.76 10151

AST NADH 340/380 205.3 5.3 4.76 8141

AST Activated NADH 340/380 182.4 7.4 4.76 5180

CK NADH 340/412 204.0 4.0 5.68 8974

GGT A PNA* 412/660 204.0 4.0 6.31 8077

LD NADH 340/380 203.2 3.2 4.76 13341




Calibrators

Multiconstituent Calibrator (MCC), LN 1E65

Customers may observe differences among MCC calibrator lot numbers, within these specifications:

• Color—colorless to yellow

• Clarity—clear to opaque

Product Information

Calibrator Product Name List Number Configuration Assays

Multiconstituent 1E65-02 CAL 1: 3 x 5 mLCAL 2: 3 x 5 mL

AlbCaCholCreaCrea-UGluGlu-UPhos

Phos-UTPTrigUProUreaUrea-UUric

MCC DOA Cutoff 2G90-02 1 x 14 mL AmpMBarbBenzCocMeth

Opi2PCPPrpxTHC50

Apo Al/Apo B 6E54-02 1 x 1 mL ApoA ApoB

Bilirubin 1E66-03 CAL 1: 3 x 5 mLCAL 2: 3 x 5 mL

BilDBilN

BilT

C-Reactive Protein 8G68-02 CAL 1: 1 x 2 mLCAL 2: 1 x 2 mLCAL 3: 1 x 2 mLCAL 4: 1 x 2 mLCAL 5: 1 x 2 mLCAL 6: 1 x 2 mL

CRP

Carbamazepine 6E90-02 CAL 1: 1 x 5 mLCAL 2: 1 x 2 mLCAL 3: 1 x 2 mLCAL 4: 1 x 2 mLCAL 5: 1 x 2 mLCAL 6: 1 x 2 mL

Carb




Carbon Dioxide 1E64-02 CAL 1: 3 x 5 mLCAL 2: 3 x 5 mL

CO2

Digoxin 1E06-02 CAL 1: 1 x 4.8 mLCAL 2: 1 x 1.8 mLCAL 3: 1 x 1.8 mLCAL 4: 1 x 1.8 mLCAL 5: 1 x 1.8 mLCAL 6: 1 x 1.8 mL

Dig

Ethanol 9F59-02 (0 mg/dL)1G82-02 (100 mg/dL)

CAL 1: 1 x 3 mLCAL 2: 1 x 3 mL

ETOH

HDL 1E68-02 6 x 1 mL HDL

Hemoglobin A1c 2K96-02 CAL 1: 1 x 8 mLCAL 2: 1 x 2 mLCAL 3: 1 x 2 mLCAL 4: 1 x 2 mLCAL 5: 1 x 2 mLCAL 6: 1 x 2 mL

HbA1c

ICT™ (Serum) 1E46-02 CAL 1: 5 x 10 mLCAL 2: 5 x 10 mL

NaK

Cl

ICT Urine 1E47-02 URINE CAL L:5 x 10 mLURINE CAL H:5 x 10 mL

Na-UK-U

Cl-U

Iron/Magnesium 1E69-02 CAL 1: 3 x 5 mLCAL 2: 3 x 5 mL

IronMg

TIBC

Lactic Acid 1E75-02 1 x 10 mL Lact

Lipase 3E16-02 2 x 3 mL Lip

Microalbumin 2K98-02 CAL 1: 1 x 2 mLCAL 2: 1 x 2 mLCAL 3: 1 x 2 mLCAL 4: 1 x 2 mLCAL 5: 1 x 2 mL

uAlb

Opiates 300 2G92-02 1 x 14 mL Opi3





Phenobarbital 5F54-02 CAL 1: 1 x 5 mLCAL 2: 1 x 2 mLCAL 3: 1 x 2 mLCAL 4: 1 x 2 mLCAL 5: 1 x 2 mLCAL 6: 1 x 2 mL

Pheno

Prealbumin 6E57-02 CAL 1: 1 x 1 mLCAL 2: 1 x 1 mLCAL 3: 1 x 1 mLCAL 4: 1 x 1 mLCAL 5: 1 x 1 mL

PAlb

Rheumatoid Factor 8G67-02 CAL 1: 1 x 1 mLCAL 2: 1 x 1 mLCAL 3: 1 x 1 mLCAL 4: 1 x 1 mLCAL 5: 1 x 1 mL

RF

Specific Proteins Multiconstituent

1E78-02 CAL 1: 1 x 1 mLCAL 2: 1 x 1 mLCAL 3: 1 x 1 mLCAL 4: 1 x 1 mLCAL 5: 1 x 1 mL

C3C4HaptIgA

IgGIgMTRF

Theophylline 6E89-02 CAL 1: 1 x 5 mLCAL 2: 1 x 2 mLCAL 3: 1 x 2 mLCAL 4: 1 x 2 mLCAL 5: 1 x 2 mLCAL 6: 1 x 2 mL

Theo

Urine/CSF Protein 1E71-02 CAL 1: 1 x 5 mLCAL 2: 1 x 5 mLCAL 3: 1 x 5 mLCAL 4: 1 x 5 mLCAL 5: 1 x 5 mL

UPro

Valproic Acid 1E13-02 CAL 1: 1 x 1 mLCAL 2: 1 x 1 mLCAL 3: 1 x 1 mLCAL 4: 1 x 1 mLCAL 5: 1 x 1 mLCAL 6: 1 x 1 mL

VPA





Chemical Reactions for Clinical Chemistry Assays

Assay Name

Reaction Tips

ACP

α-Naphthylphosphate α-Napthol + PO4-3

α-Napthol + Diazotized 2-amino-5-chlorotoluene Dye complex

Use fresh, nonhemolyzed, nonicteric, and nonlipemic serum samples. All specimens need to be stabilized with 50 µL Liquid Stabilizer for every 1 mL of serum. The acidified serum should be analyzed immediately, or stored at 2 to 8°C, or frozen. Calibration is stable for approximately five days and performed using a water blank. Sample Interference Indices may assist with determination of sample integrity.

AlbG (BCG)

Albumin + BCG Colored complex

BCG = Bromcresol green

Results are running high, due to non-specific protein binding. Recommend AlbP if more specificity needed.

AlbP (BCP)

Human Albumin + BCP Colored complex

BCP = Bromcresol purple

Human albumin specific.

AlkP p-Nitrophenylphosphate + H2O p-Nitrophenol + phosphate AlkP reagent contains AMP buffer.

ALT

L-Alanine + α-Ketoglutarate Pyruvate + L-glutamate

Pyruvate + NADH L-lactate + NAD+

LD = Lactate dehydrogenaseNADH = Nicotinamide adenine dinucleotide

Do not use plasma samples collected using ammonium heparin.

* MULTIGENT® assay

ACP

AlkP

Mg+2, Zn+2

ALT

LD




ALT-A

L-Alanine + α-Ketoglutarate Pyruvate + L-glutamate

Pyruvate + NADH L-lactate + NAD+

LD = Lactate dehydrogenaseNADH = Nicotinamide adenine dinucleotide

Activated reagent contains pyridoxal-5-phosphate (P-5-P).


AmpM

Antibody to AmpM (R1) + G-6-PD-AmpM (R2) (Active)

G-6-PD-AmpM:Antibody complex (Inactive)

G-6-PD-AmpM:Antibody complex (Inactive) + AmpM G-6-PD-AmpM (Active) + AmpM:Antibody complex

G-6-PD-AmpM (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate

G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial sourceNADH = Nicotinamide adenine dinucleotide

Use Multi DOA Cutoff calibrator in duplicate for calibration. Cutoff calibrator value is zero on CALIBRATOR/CONTROL screen.

Amy10 CNPG3 9 CNP + 1 CNPG2

CNPG3 = 2-chloro-4 nitrophenyl-α D-maltotrioside

Chromophore is 2-chloro-4-nitrophenol (CNP), read at 404 nm.

ApoA

Apo-A1 + PEG/buffer (R1) + Antibody to Apo-A1 (R2) Turbidity due to Apo-A1:Antibody complex

PEG = Polyethylene glycol

ApoB

Apo-B + PEG/buffer (R1) + Antibody to Apo-B (R2) Turbidity due to Apo-B:Antibody complex


AST

L-Aspartate + α-Ketoglutarate Oxaloacetate + L-glutamate

Oxaloacetate + NADH L-Malate + NAD+

MD = Malate dehydrogenaseNADH = Nicotinamide adenine dinucleotide


Assay Name

Reaction Tips

* MULTIGENT® assay

ALT, P-5-P

LD

α-amylase

AST

MD




AST-A

L-Aspartate + α-Ketoglutarate Oxaloacetate + L-glutamate

Oxaloacetate + NADH L-Malate + NAD+

NADH = Nicotinamide adenine dinucleotideMD = Malate dehydrogenase

Activated reagent contains pyridoxal-5-phosphate (P-5-P).


Barb

Antibody to Barbiturates (R1) + G-6-PD-Barbiturates (R2) (Active) G-6-PD-Barbiturates:Antibody complex (Inactive)

G-6-PD-Barbiturates:Antibody complex (Inactive) + Barbiturates G-6-PD-Barbiturates (Active) + Barbiturates:Antibody complex

G-6-PD-Barbiturates (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate



Benz

Antibody to Benzodiazepines (R1) + G-6-PD-Benzodiazepines (R2) (Active) G-6-PD-Benzodiazepines:Antibody complex (Inactive)

G-6-PD-Benzodiazepines:Antibody complex (Inactive) + Benzodiazepines G-6-PD-Benzodiazepines (Active) + Benzodiazepines:Antibody complex

G-6-PD-Benzodiazepines (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate



Does not correlate well with AxSYM® Benzodiazepines assay.

Assay Name

Reaction Tips

* MULTIGENT® assay

AST, P-5-P

MD




BilD(LN 8G63-20)

Direct (Conjugated) Bilirubin + 2,4-Dichlorophenyl diazonium salt

Azobilirubin

The formation of azobilirubin is measured spectrophoto-metrically and is directly proportional to the concentration of bilirubin.

Avoid hemolysis during sample collection. Protect samples from light.

Same formulation as LN 2K59-20.

BilT(LN 8G62-20)

Total (Conjugated & Unconjugated) Bilirubin + 2,4-Dichlorophenyl

diazonium salt Azobilirubin



Same formulation as LN 2K58-20.

C3

Complement C3 + PEG/buffer (R1) + Antibody to C3 (R2) Turbidity due to C3:Antibody complex


C4

Complement C4 + PEG/buffer (R1) + Antibody to C4 (R2) Turbidity due to C4:Antibody complex


Analyze fresh or refrigerate at 2 to 8°C no more than two days.

Ca 2 Arsenazo III + Ca+2 Ca-Arsenazo complex+2 (blue-purple)

Must not be on the same line as the Lipase assay.New reference range: 9.0 to 10.4 mg/dL.

Assay Name

Reaction Tips

* MULTIGENT® assay

Acid

Surfactant




Carb

Antibody to Carbamazepine (R1) + G-6-PD-Carbamazepine (R2) (Active) G-6-PD-Carbamazepine:Antibody complex (Inactive)

G-6-PD-Carbamazepine:Antibody complex (Inactive) + Carbamazepine G-6-PD-Carbamazepine (Active) + Carbamazepine:Antibody complex

G-6-PD-Carbamazepine (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate


Blank this assay with Carb CAL 1.

When either the R1 or R2 reagent cartridge is empty, replace both cartridges and validate the system by analyzing controls.

Chol

Cholesterol esters + H2O Cholesterol + fatty acids

Cholesterol + O2 Cholest-4-ene-3-one + H2O2

2H2O2 + HBA + 4-AAP Quinoneimine dye + 4H2O

CE = Cholesterol esteraseCO = Cholesterol oxidase4-AAP = 4-AminoantipyrineHBA = Hydroxybenzoic acidPOD = Peroxidase

According to the National Cholesterol Education Program (NCEP), patients need not be fasting.Assay certified against Cholesterol Reference Method Laboratory Network (CRMLN) reference method.Must not be on the same line as the Lipase assay.

CK

ADP + Creatine phosphate ATP + Creatine

ATP + Glucose ADP + Glucose-6-phosphate

G-6-P + NADP+ 6-phosphogluconate + NADPH

HK = HexokinaseG-6-PD = Glucose-6-phosphate dehydrogenase

R1 contains N-acetylcysteine; therefore, this is a “NAC” CK method.

Assay Name

Reaction Tips

* MULTIGENT® assay

CE

CO

POD

CK

HK

G-6-PD




CO2

Phospho(enol)pyruvate + HCO3- Oxaloacetate + H2PO4

-

Oxaloacetate + NADH + H+ Malate + NAD+

PEPC = Phospho(enol)pyruvate carboxylaseNADH = Nicotinamide adenine dinucleotideMD = Malate dehydrogenase

Must not be on the same line as the Lipase assay.

Perform a calibration with each CO2 reagent cartridge used and with each new reagent lot.

Run a minimum of two levels of control with each new CO2 reagent cartridge and at a minimum of eight hour intervals between calibrations.

Discard the CO2 reagent cartridge with 50 tests remaining.

Coc

Antibody to Cocaine (R1) + G-6-PD-Cocaine (R2) (Active) G-6-PD-Cocaine:Antibody complex (Inactive)

G-6-PD-Cocaine:Antibody complex (Inactive) + Cocaine G-6-PD-Cocaine (Active) + Cocaine:Antibody complex

G-6-PD-Cocaine (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate



Crea Creatinine + Picrate Creatinine-picrate complex

24 hour calibration requirement due to onboard refrigerated storage.

Based on traditional Jaffe reaction.

CRPCRP (Sample) + Buffer (R1) + Antibody to CRP adsorbed to latex particles (R2)

Turbidity due to agglutination of CRP:Antibody:Particle complex

This method is not suitable for high-sensitivity (HS) measurements.

Assay Name

Reaction Tips

* MULTIGENT® assay

Mg+2PEPC

MD

Alkaline pH




DBil(LN 7D59)

Bilirubin Biliverdin

CAP survey results show a 38.2% CV for 16 different chemistry methodologies. The AEROSET System produces higher biliverdin values than most other analyzers. A factor may be entered to adjust. Not intended for use with neonatal specimens.

Abbott reagent LN 8G63-20 is the same reagent formulation as DCL labeled product LN 2K59-20.

DIBIL(LN 2K59-20,DCL Label)

Direct Bilirubin + 2,4-Dichlorophenyl diazonium salt Azobilirubin



Same formulation as LN 8G63-20.

Dig*

Digoxin + Antibody to Digoxin/BIS-TRIS buffer (R1) + Digoxin-coated

Microparticles (R2)

Digoxin:Antibody complex + Digoxin-coated Microparticle:Antibody complex

Digoxin concentration is inversely proportional to absorbance change. (High absorbance change = low digoxin concentration; low absorbance change = high digoxin concentration.)

Assay Name

Reaction Tips

* MULTIGENT® assay

Oxidation

Sodium Nitrite

Acid

Competition




ETOH

ADHEthyl Alcohol + NAD NADH + acetaldehyde

ADH = Alcohol dehydrogenaseNADH = Nicotinamide adenine dinucleotide

Uses Ethanol 0 and 100 mg/dL calibrators for calibration.

Sample handling: ethanol is a volatile analyte. To prevent evaporation, ethanol sample containers must be kept tightly capped.

GGT

L-γ-glutamyl-3-carboxy-4-nitroanilide + glycylglycine

L-γ-glutamyl-glycylglycine + 3-carboxy-4-nitroaniline

The Roche GGT assay on the Roche/Hitachi 717 has approximately a 30% low bias compared to the AEROSET System. Abbott has documentation to support this bias and the accuracy of the AEROSET values. The AEROSET methodology utilizes the IFCC method.

Glu

Glucose + ATP Glucose-6-Phosphate + ADP

Glucose-6-phosphate + NADP+ 6-Phosphogluconate + NADPH

HK = HexokinaseG-6-PD = Glucose-6-phosphate dehydrogenase

Hapt

Haptoglobin + PEG/buffer (R1) + Antibody to haptoglobin (R2) Turbidity due to Haptoglobin:Antibody complex


Assay Name

Reaction Tips

* MULTIGENT® assay

GGT

HK

G-6-PD




HbA1c*

Total Hemoglobin:

Hemoglobin + Alkaline Non-ionic surfactant

Hematin (green solution)

Hemoglobin A1c:

HbA1c + Anti-HbA1c Antibody:Microparticle complex

HbA1c:Antibody:Microparticle complex

Remaining unbound Anti-HbA1c:Antibody:Microparticle complex +

HbA1c Hapten HbA1c Hapten:Antibody:Microparticle complex

HbA1c concentration is inversely proportional to absorbance change. (High absorbance change = low HbA1c concentration; low absorbance change = high HbA1c concentration.)

HDL

HDL, LDL, VLDL, Chylomicrons Stable complexes

HDL HDL Disrupted

HDL Cholesterol ∆4 Cholestenone + H2O2

H2O2 + DSBmT + 4-AAP Quinoneimine Dye + H2O

DSBmT = N,N-bis(4-sulphobutyl)-m-toluidine-disodium4-AAP = 4-Aminoantipyrine

Linearity and control material must be human-based material.

IgA

IgA + PEG/buffer (R1) + Antibody to IgA (R2) Turbidity due toIgA:Antibody complex


IgG

IgG + PEG/buffer (R1) + Antibody to IgG (R2) Turbidity due toIgG:Antibody complex


IgG may be very elevated due to an IgG monoclonal paraprotein.

IgM

IgM + PEG/buffer (R1) + Antibody to IgM (R2) Turbidity due toIgM:Antibody complex


Samples containing high IgM can have increased viscosity.

Assay Name

Reaction Tips

* MULTIGENT® assay

Detergent

Polyanion

Detergent

Cholesterol Esterase

Cholesterol Oxidase

Peroxidase




Iron

Fe-transferrin Fe+3 + transferrin

Fe+3 Fe+2

Fe+2 + FERENE Fe-FERENE complex

Serum only. Separate from red blood cells as soon after collection as possible.

Deferoxamine mesylate interferes with this assay.

Lact

Lactic Acid Pyruvate + H2O2

H2O2 + Chromogen Dye complex

LO = Lactate oxidase

Venous specimens should be obtained without the use of a tourniquet or immediately after the tourniquet is applied.

Specimen must be collected using a fluoride-oxalate tube, centrifuged as soon after collection as possible and immediately remove the plasma from the red blood cells.

Calibration is required each time a new reagent is reconstituted.

LD

L-lactate + NAD+ Pyruvate + NADH + H+

NADH = Nicotinamide adenine dinucleotide

When correlating, verify whether the comparison method is L � P or P � L, since AEROSET LD utilizes the forward reaction (L � P) which gives lower results (U/L).

Assay Name

Reaction Tips

* MULTIGENT® assay

pH 4.5

Hydroxylamine Hydrochlorided hl d

LO

Peroxidase

LD




LDL*

HDL, LDL, VLDL, Chylomicrons LDL (non-LDL particlesconsumed in a non-color forming reaction)

LDL Cholesterol Cholesterone + H2O2

H2O2 + DSBmT + 4-AAP Quinoneimine dye + H2O

DSBmT = N,N-bis(4-sulphobutyl)-m-toluidine-disodium4-AAP = 4-Aminoantipyrine

MULTIGENT Direct LDL must not be on the same line as the Lipase assay.

Samples may be frozen one time at -80°C.

Lip

1,2 Diglyceride + H2O 2-Monoglyceride + fatty acid

2-Monoglyceride + H2O Glycerol + fatty acid

Glycerol + ATP Glycerol-3-phosphate + ADP

Glycerol-3-phosphate + O2 Dihydroxyacetone phosphate + H2O2

2H2O2 + 4-AAP + TOOS Quinoneimine dye + 4H2O

4-AAP = 4-Aminoantipyrine

TOOS = N-ethyl-N-(2-hydroxy)-3-sulfopropyl-m-toluidine

There are reports of interference by non-Abbott HDL methods. Correct SmartWash™ configuration is critical for some assays.

Serum only.

Must not be on the same line as Triglyceride, Calcium, Urine Calcium, Cholesterol, CO2, MULTIGENT LDL, and Uric Acid.

Meth

Antibody to Methadone (R1) + G-6-PD-Methadone (R2) (Active) G-6-PD-Methadone:Antibody complex (Inactive)

G-6-PD-Methadone:Antibody complex (Inactive) + Methadone G-6-PD-Methadone (Active) + Methadone:Antibody complex

G-6-PD-Methadone (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate



Assay Name

Reaction Tips

* MULTIGENT® assay

Detergent 1

COCE

POD

Detergent 2

Peroxidase

Lipase

MGLP

GK

GPO

POD




Mg Arsenazo III + Mg+2 Mg-Arsenazo III complex

Perform calibration with each reagent cartridge used.

24 hour calibration requirement due to onboard refrigerated storage.

Reagent contains chelating agents to prevent calcium interference.

NBil Bichromatic spectrophotometric absorbance only; no chemical reaction

Valid only in neonates, due to low concentration of carotenes in serum.

Opi

Antibody to Opiates (R1) + G-6-PD-Opiates (R2) (Active) G-6-PD-Opiates:Antibody complex (Inactive)

G-6-PD-Opiates:Antibody complex (Inactive) + Opiates G-6-PD-Opiates (Active) + Opiates:Antibody complex

G-6-PD-Opiates (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate


Opiates 300: Use Opiates 300 calibrator in duplicate for calibration.

Calibrator value is zero on CALIBRATOR/CONTROL screen for both Opiates 300 and Opiates 2,000 assays.

Opiates 2,000: Use Multi DOA Cutoff calibrator in duplicate for calibration.

PAlb

Prealbumin + PEG/buffer (R1) + Antibody to prealbumin (R2) Turbidity due to prealbumin:Antibody complex


Serum samples only. Alternate test method: nephelometry.

Assay Name

Reaction Tips

* MULTIGENT® assay




PCP

Antibody to Phencyclidine (R1) + G-6-PD-Phencyclidine (R2) (Active) G-6-PD-Phencyclidine:Antibody complex (Inactive)

G-6-PD-Phencyclidine:Antibody complex (Inactive) + Phencyclidine G-6-PD-Phencyclidine (Active) + Phencyclidine:Antibody complex

G-6-PD-Phencyclidine (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate


Use Multi DOA Cutoff calibrator in duplicate for calibration. Cutoff calibrator value is zero on CALIBRATOR/ CONTROL screen.

Pheno

Antibody to Phenobarbital (R1) + G-6-PD-Phenobarbital (R2) (Active) G-6-PD-Phenobarbital:Antibody complex (Inactive)

G-6-PD-Phenobarbital:Antibody complex (Inactive) + Phenobarbital G-6-PD-Phenobarbital (Active) + Phenobarbital:Antibody complex

G-6-PD-Phenobarbital (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate


Blank this assay with Pheno CAL 1.


Pheny

Antibody to Phenytoin (R1) + G-6-PD-Phenytoin (R2) (Active) G-6-PD-Phenytoin:Antibody complex (Inactive)

G-6-PD-Phenytoin:Antibody complex (Inactive) + Phenytoin G-6-PD-Phenytoin (Active) + Phenytoin:Antibody complex

G-6-PD-Phenytoin (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate


Blank this assay with Pheny CAL 1.


Phos Phosphate + molybdate Heteropolyacid complex

Assay Name

Reaction Tips

* MULTIGENT® assay

H+




Prpx

Antibody to Propoxyphene (R1) + G-6-PD-Propoxyphene (R2) (Active) G-6-PD-Propoxyphene:Antibody complex (Inactive)

G-6-PD-Propoxyphene:Antibody complex (Inactive) + Propoxyphene G-6-PD-Propoxyphene (Active) + Propoxyphene:Antibody complex

G-6-PD-Propoxyphene (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate


Use Multi DOA Cutoff calibrator in duplicate for calibration. Cutoff calibrator value is zero on CALIBRATOR/ CONTROL screen.

RFRF (Sample) + Buffer (R1) + Antibody to RF adsorbed to latex particles (R2)

Turbidity due to agglutination of RF:Antibody:Particle complex

TBil(LN 7D60)

Conjugated & Unconjugated Bilirubin Biliverdin

Abbott reagent LN 8G62-20 is the same reagent formulation as DCL labeled product LN 2K58-20.

Assay Name

Reaction Tips

* MULTIGENT® assay

Detergent

Solubilizer

Sodium Nitrite

Oxidation




THC50

Antibody to THC (R1) + G-6-PD-THC (R2) (Active) G-6-PD-THC:Antibody complex (Inactive)

G-6-PD-THC:Antibody complex (Inactive) + UC G-6-PD-THC (Active) + UC:Antibody complex

G-6-PD-THC (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate

THC = ∆9-TetrahydrocannabinolG-6-PD = Glucose-6-phosphate dehydrogenase from bacterial sourceUC = Urine cannabinoidsNADH = Nicotinamide adenine dinucleotide


Certain types of plastics adsorb cannabinoids (THC) from solutions, decreasing the concentration. To prevent adsorbtion:

• Fill AEROSET sample cups with 600 µL to minimize surface-to-volume ratio.

• Do not use disposable polyethylene transfer pipettes to dispense urine specimens, calibrator, or controls.

• Do not redispense solutions from a pipette into a calibrator, controls, or specimen container (includes redispensing after wetting pipette tip).

• Immerse pipette tip below surface of the liquid only far enough to aspirate the needed volume.

Assay Name

Reaction Tips

* MULTIGENT® assay




Theo

Antibody to Theophylline (R1) + G-6-PD-Theophylline (R2) (Active) G-6-PD-Theophylline:Antibody complex (Inactive)

G-6-PD-Theophylline:Antibody complex (Inactive) + Theophylline G-6-PD-Theophylline (Active) + Theophylline:Antibody complex

G-6-PD-Theophylline (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate


Blank this assay with Theo CAL 1.


TIBC

Apotransferrin + excess Fe+3 Fe-transferrin + Fe+3

Fe+3 + Fe-transferrin + alumina Eluent of Fe-transferrin;analyzed using Iron Reagent (LN 7D68)

Serum only.

TOBIL (LN 2K58-20,DCL Label)

Total (Conjugated & Unconjugated) Bilirubin + 2,4-Dichlorophenyl

diazonium salt Azobilirubin



Same formulation as LN 8G62-20.

TPCu+2 Cu+2-Protein Nitrogen complex

(Biuret reaction)

Dextran interferes with the Total Protein assay, a biuret method. Plasma values are generally 0.3 to 0.5 g/dL higher than serum values, due to the presence of fibrinogen.

Assay Name

Reaction Tips

* MULTIGENT® assay

Saturating Solution

AdsorbentColumns

Surfactant

OH-




TRF

Transferrin + PEG/buffer (R1) + Antibody to transferrin (R2) Turbidity due to transferrin:Antibody complex


Trig

Triglyceride + 3H2O Glycerol + 3 Fatty Acids

Glycerol + ATP Glycerol-3-phosphate + ADP

Glycerol-3-phosphate + O2 DAP + H2O2

H2O2 + 4-AAP + 4-CP Quinoneimine dye + 2H2O

ATP = Adenosine triphosphateGK = Glycerol kinaseGPO = Glycerol phosphate oxidaseDAP = Dihydroxyacetone phosphate4-AAP = 4-Aminoantipyrine4-CP = Chlorophenol

The expected range for Triglyceride stated in the package insert is < 200 mg/dL. The low reference value configured on the Assay Configuration screen is defined as 1 because the software does not allow for a “<” sign reference value. Must not be on the same line as the Lipase assay.

Hyperlipemic samples require a dilution to be performed to ensure accurate results.

uAlb*Microalbumin + Good’s buffer (R1) + TRIS buffer (R2) + Anti-human albumin

(goat) antibody (R2) Turbidity due to Microalbumin:Anti-human albumin (goat) antibody complex (Insoluble)

The degree of turbidity is proportional to albumin concentration in the specimen.

UProNative Protein + Benzethonium Chloride Denatured protein precipitate

(detected turbidimetrically)

This is a non-specific method that does not detect many proteins in urine and CSF.

Urea

Urea + H2O 2NH3 + CO2

NH3 + α-Ketoglutarate + NADH Glutamate + NAD+ + H2O

NADH = Nicotinamide adenine dinucleotideGLD = Glutamate dehydrogenase

Assay Name

Reaction Tips

* MULTIGENT® assay

Lipase

GK

GPO

Peroxidase

Urease

GLD




Uric

Uric Acid + O2 + H2O Allantoin + CO2 + H2O2

2H2O2 + 4-AAP + TBHB Quinoneimine + H2O

TBHB = 2,4,6 Tribromo-3-hydroxy benzoic acid4-AAP = 4-Aminoantipyrine

Calibrate each reagent cartridge. Run a minimum of two levels of control with each new reagent cartridge.

Ascorbate interferes with this method.

Currently, Sigma linearity standards recover at approximately 50% for the highest level on the AEROSET System. The same is seen with Roche assays run on the Roche/Hitachi. Verichem linearity was able to recover at 100%.

VPA*

Valproic Acid + Antibody to Valproic Acid/BIS-TRIS buffer (R1) +

Valproic Acid-coated Microparticles (R2)

Valproic Acid:Antibody complex + Valproic Acid-coated Microparticle:Antibody complex

Valproic acid concentration is inversely proportional to absorbance change. (High absorbance change = low valproic acid concentration; low absorbance change = high valproic acid concentration.)

Assay Name

Reaction Tips

* MULTIGENT® assay

Uricase

Peroxidase

Competition




Drugs of Abuse (DOA) AssaysAssay Details

Trade/Alternate Name Street Name Physical

Description

Major Compounds/Metabolites

Amphetamine/Methamphet-amine

Dexedrine, Ritalin, Adderall,N-Methylamphetamine

Bennies, Dexies, Uppers, Meth, Doe, Crystal, Ice

Capsules, tablets, liquid

Amphetamine, Methamphet-amine, and hydroxy metabolites

Barbiturates Amytal (amobarbital sodium), Nembutal® (pentobarbital sodium), Seconal (secobarbital sodium), Fiorinal (butalbital), Butisol

Blues, Blue Dolls, Rainbows, Yellows, Yellow Jackets, Nebbies, Reds, Red Devils, M&M’s, Barbs, Downers

Capsules, tablets

Parent compounds of each with hydroxy metabolite

Benzodiazepines Valium (diazepam), Tranxene (clorazepate), Librium(chlordiazepoxide), Serax (oxazepam), Dalmane (flurazepam), Ativan (lorazepam) Xanax (alprazolam), Versed, Halcion,Restoril

Benzos, mellow, “Mickey Finn” (when used with alcohol)

Powder, capsules, tablets

Oxazepam (for diazepam and chlordiazepoxide)

Cannabinoids Marinol (dronabinol) THC, Mary Jane, Weed, Grass, Pot, Hash, Reefer, Ganja, Dope

Capsules; plant material—flowering tops, leaves and seeds, small stems coated with resinous oil

11-nor-∆9-THC-9-carboxylic acid and other marijuana metabolites

Cocaine Cocaine hydrochloride Coke, Rock, Snow, Flake, Blow, Crack

• Free base form—rocks (“dime rocks”)

• White powder

Benzoylecgonine, 3-Methyl-ecgononine, Ecgonine

Ethanol Ethanol, beer, wine, liquor, Everclear

Booze, Hooch, Sauce Liquid, flavorings added for taste

Acetaldehyde, acetic acid




Methadone Dolophine, Amidone Methadose Tablets Methadone (EDDP) and metabolites

Opiates Heroin: DiacetylmorphineMorphine: Duramorph, Oramorph, MSContinOther: Meperidine (Demerol, Mepergan), Hydromorphone (Dilaudid), Oxycodone (OxyContin, Percodan, Percocet), Codeine

• Heroin: Smack, Horse, White Lady, Skag, “H”

• Morphine: Junk, White Stuff, Morpho, “M”

• Other: analgesics, anti-tussives

• Heroin: brown to white powder

• Morphine: small white tablets or powder, injectable form

• Other: tablets, liquid, powder, and injectable forms

• Heroin: Morphine

• Morphine: Morphine

• Other: Codeine to morphine parent compound

Phencyclidine None Angel Dust, Hog, Killer Weed (when used on marijuana)

Fine white powder

PCP and metabolites

Propoxyphene Darvon, Darvocet-N Yellow Footballs Capsules, tablets

Propoxyphene and norpropoxyphene

Assay Details (Continued)

Trade/Alternate Name Street Name Physical

Description

Major Compounds/Metabolites





UseNormal

Detection Time in Urine

Symptoms of Abuse Possible Dangers


Taken orally, injected, inhaled

Dependent on urine pH: 3 to 5 days

Insomnia, psychosis, anorexia, euphoria, tachycardia

High blood pressure, loss of appetite and weight

Barbiturates Taken orally • Phenobarbital: up to 30 days

• Amobarbital, pentobarbital, butabarbital, secobarbital: 4 to 6 days

Drowsiness, slurred speech, irritability

• Acute: respiratory collapse, loss of consciousness

• Chronic: addiction• Abstinence:

seizures, death• Deadly when

combined with alcohol

Benzodiazepines Taken orally • Flurazepam: 1 to 2 days

• Oxazepam, etc.: 2 to 7 days

“Laid back,” mellow personality, mental confusion

• Acute: intoxication, loss of inhibitions

• Chronic: addiction, involuntary muscle movements of the face, limbs, and trunk (tardive dyskinesia)

Cannabinoids • Smoked as cigarette or in a pipe

• Eaten as part of other food (brownie, salad)

• Occasional user: 3 to 5 days

• Chronic user: up to 14 days

• Large person, chronic user: up to 30 days (based on 25 ng/mL detection limit)

Indifference (lethargy), confusion, lazy (amotivational syndrome), slow mental activity

• Acute: intoxication similar to alcohol

• Chronic: amotivational syndrome, decreased emotional development, increased susceptibility to disease




Cocaine • Free base: vaporized then smoked

• White power: intravenously, nasal insuffulation (“snorting” or “sniffing”)

2 to 3 days Extreme euphoria, insomnia, psychosis, anorexia, rapid heart rate (transient tachycardia)

High blood pressure, abnormal heartbeat pattern (cardiac arrhythmia), elevated temperature, stroke, heart failure, psychosis

Ethanol Taken orally Dose dependent: up to 24 hours

Mental confusion, vomiting, blackouts, personality change when drinking

• Acute: intoxication, hangover, vomiting, death

• Chronic: abstinence—seizures, addiction, inflammation of stomach lining (gastritis), inflammation of liver (hepatitis), inflammation of pancreas (pancreatitis), death

Methadone Taken orally 14 days • Acute: abnormal sense of well-being (euphoria)

• “Good sick”: nauseous but it feels pleasurable

• “Nod”: central nervous system (CNS) depression, drowsiness

• Withdrawal: watery eyes, salivation, GI symptoms, discomfort, agitation

Addiction, but less than morphine or heroin


UseNormal






Opiates Intravenously, orally

• Heroin: rapidly metabolizes to morphine, 72 hours

• Morphine: 3 days

• Other: 2 to 4 days

• Acute: Abnormal sense of well-being (euphoria)

• “Good sick”: nauseous but it feels pleasurable

• “Nod”: central nervous system (CNS) depression, drowsiness

• Withdrawal: watery eyes, salivation, GI symptoms, discomfort, agitation

Addiction, overdose, death

Phencyclidine Smoked on marijuana, taken intravenously or orally

Up to 10 days Aggressive behavior, combativeness, involuntary rhythmic movements of eyes (nystagmus), uncoordinated movement (ataxia)

Aggressive and dangerous behavior, persistently elevated blood pressure (hypertension), seizures, involuntary muscle contractions (spasms)

Propoxyphene Orally, intravenously

7 days • Acute: abnormal sense of well-being (euphoria), drowsiness, slurred speech

• Withdrawal: agitation, seizures

Addiction, overdose, death


UseNormal






Cross Reactivity

Refer to Assay-specific Information in this section for additional assay-specific cross reactivity information. Each DOA assay includes a table which lists cross reactivity testing performed on the AEROSET System by SYVA; this information is not included in the Abbott Clinical Chemistry Drugs of Abuse package inserts.

Method Comparison

For the qualitative drug of abuse assays Amphetamine/Methamphetamine, Barbiturates, Benzodiazepines, Cannabinoids, Cocaine, Methadone, Opiates, Phencyclidine, and Propoxyphene, urine samples known to be free from interfering substances or other drugs should be used. Run 40 positive and 40 negative specimens. The concentration of drug should cover the entire assay range, with particular emphasis at the cutoff concentration. All discrepant data points between the AEROSET DOA assay and comparative method should be investigated further by GC/MS to confirm the results.

Because the Ethanol assay is a quantitative assay, routine method comparison studies should be performed. Serum and urine samples known to be free from interfering substances or other drugs should be used. Run 40 positive and 40 negative specimens. The concentration of drug should cover the entire assay range.

For the c 8000® System, the package insert describes rate results between the cutoff rate and ± 25% rate, also the ± 50% rate. For the AEROSET System, only results between the cutoff rate and ± 25% rate are discussed, not the ± 50% rate. This is because of the new Guidance for Industry and FDA staff document, Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests, released December 2, 2003. AEROSET method comparison rate results were completed before the guidance document was updated.




MULTIGENT® Assays

General Information

MULTIGENT assays are supplied to Abbott from Original Equipment Manufacturers (OEM) and include Abbott Laboratories as the distributor on all MULTIGENT labeling. The MULTIGENT assay menu, including OEM supplier information, is listed in the following table.

Manufacturer Information

Seradyn, Inc.7998 Georgetown Road, Suite 1000Indianapolis, IN 46268(800) 428-4072(317) 610-3828www.seradyn.com

Genzyme DiagnosticsOne Kendall SquareCambridge, MA 02139-1562(800) 332-1042(617) 252-7500www.genzymediagnostics.com

Wako Chemicals USA, Inc.1600 Bellwood RoadRichmond, VA(877) 714-1924(804) 271-7677www.wakousa.com

MULTIGENT Assay OEM Supplier

Digoxin Seradyn

Direct LDL Genzyme

Hemoglobin A1c Seradyn

Microalbumin Wako

Valproic Acid Seradyn




Plasma Claims for Gel Barrier TubesFor assays that allow plasma as a suitable specimen, the following statement appears in the package insert: “Use plasma collected by standard venipuncture techniques in glass or plastic tubes without gel barrier”.

Clarification—plasma tubes with a gel barrier were not tested; therefore, no claim is made for these types of tubes.




Proficiency Testing

AAB Reagent Codes

Analyte Code Methodology

Albumin BCG 130 Abbott bromcresol green

Albumin BCP 146 Abbott bromcresol purple

Alkaline Phosphatase 146 Abbott no DEA 37°C

ALT 147 Abbott no P5P 37°C

Amylase 135 Abbott CNPG3 substrate

AST 147 Abbott no P5P 37°C

Bicarbonate (CO2) 146 Abbott UV/serum blanks

Bilirubin, Total (LN 7D60)

147 Abbott oxidation

Calcium 135 Abbott arsenazo III

Chloride 135 Abbott diluted ISE

Cholesterol, Total 146 Abbott

Creatine Kinase (CK) 146 Abbott NAC 37°C

Creatinine 135 Abbott nonenzymatic rate

GGT 146 Abbott IFCC substrate 37°C

Glucose 142 Abbott hexokinase 340 nm

HDL Cholesterol 135 Abbott direct (homogeneous)

Iron 146 Abbott FERENE-based

Lactate Dehydrogenase (LD)

135 Abbott L-P 37°C

Magnesium 135 Abbott arsenazo

Phosphorus 147 Abbott UV-bichrom smp blk

Potassium 135 Abbott diluted ISE

Sodium 135 Abbott diluted ISE

Total Protein 142 Abbott bichromatic-no SB

Triglyceride 135 Abbott gly-unc/GPO

Urea 135 Abbott GLDH-rate

Uric Acid 135 Abbott enzymatic-uncorrected




CAP Codes

Serum Survey

Analyte CAP Code Methodology

Acid Phosphatase 1518 Abbott/37°C

Albumin BCG 1099 Bromcresol green/dye binding

Albumin BCP 1101 Bromcresol purple/dye binding

Alkaline Phosphatase 1518 Abbott/37°C

ALT 1518 Abbott/37°C

ALT Activated 1526 Abbott pyridoxal phosphate activated reagent/37°C

Amylase 1518 Abbott/37°C

Apolipoprotein A1 1241 Immunoturbidimetric

Apolipoprotein B 1241 Immunoturbidimetric

AST 1518 Abbott/37°C

AST Activated 1526 Abbott pyridoxal phosphate activated reagent/37°C

Bilirubin, Direct (LN 7D59)

1764 Oxidation

Bilirubin, Direct(LN 2K59, DCL)

1114 Diazo-caffeine/benzoate coupling (Jendrassik-Grof) with blank

Bilirubin, Neonatal 1120 Spectrophotometric, without blank

Bilirubin, Total (LN 7D60)

1764 Oxidation

Bilirubin, Total(LN 2K58, DCL)

1114 Diazo-caffeine/benzoate coupling (Jendrassik-Grof) with blank

Calcium 1138 Arsenazo III dye

Carbon Dioxide (CO2) 1160 Enzymatic

Chloride 1227 Ion-selective/diluted (indirect)

Cholesterol 1154 Enzymatic

Creatine Kinase (CK) 1518 Abbott/37°C

Creatinine 1161 Kinetic alkaline picrate

GGT 1518 Abbott/37°C

Glucose 1172 Hexokinase, UV* MULTIGENT® assay




Hemoglobin A1c* 1055 Abbott AEROSET

HDL, Direct 1757 Liquid selective detergent (enzymatic)

Iron 1207 FERENE without a protein removal step

Lactate Dehydrogenase (LD)

1518 Abbott/37°C

Lactic Acid 1321 Oxidation of lactate to pyruvate (automated)

LDL, Direct* 1757 Liquid select detergent (Equal, Genzyme, Pointe, ThermoTRACE)

Lipase 1518 Abbott/37°C

Magnesium 1763 Arsenazo

Phosphorus 1216 Phosphomolybdate UV

Potassium 1227 Ion-selective/diluted (indirect)

Prealbumin 3254 Abbott AEROSET

Protein, Total 1217 Biuret

Sodium 1227 Ion-selective/diluted (indirect)

TIBC 1018 Alumina adsorption

Transferrin 3254 Abbott AEROSET

Triglyceride 1685 Enzymatic (glycerol phosphate oxidase)

Urea 1253 Urease with GLDH (coupled enzyme)

Uric Acid 1262 Uricase


* MULTIGENT® assay




Urine Survey

CSF Survey

Immunology


Amylase 1518 Abbott/37°C

Calcium 1138 Arsenazo III dye

Chloride 1227 Ion-selective electrode/diluted (indirect)

Creatinine 1161 Kinetic alkaline picrate

Glucose 1172 Hexokinase, UV

Magnesium 1763 Arsenazo

Microalbumin* 1637 Turbidimetric/immunoturbidimetric

Phosphorus 1216 Phosphomolybdate, UV

Potassium 1227 Ion-selective electrode/diluted (indirect)

Sodium 1227 Ion-selective electrode/diluted (indirect)

Urea 1253 Urease with GLDH (coupled enzyme)

Uric Acid 1262 Uricase

Urine/CSF Protein 0010 Other method, specify on result form

* MULTIGENT® assay


Glucose 1172 Hexokinase, UV

Urine/CSF Protein 0010 Other method, specify on result form


C-Reactive Protein 1637 Turbidimetric/immunoturbidimetric

Complement C3 1637 Turbidimetric/immunoturbidimetric

Complement C4 1637 Turbidimetric/immunoturbidimetric

Haptoglobin 1637 Turbidimetric/immunoturbidimetric

Immunoglobulin A 1637 Turbidimetric/immunoturbidimetric

Immunoglobulin G 1637 Turbidimetric/immunoturbidimetric

Immunoglobulin M 1637 Turbidimetric/immunoturbidimetric

Rheumatoid Factor 1637 Turbidimetric/immunoturbidimetric




Therapeutic Drug Monitoring

Urine Drug Testing (Drugs of Abuse)


Carbamazepine 3254 Abbott AEROSET

Digoxin* 3254 Abbott AEROSET

Phenobarbital 3254 Abbott AEROSET

Phenytoin 3254 Abbott AEROSET

Theophylline 3254 Abbott AEROSET

Valproic Acid* 3254 Abbott AEROSET* MULTIGENT® assay


Amphetamine/ Methamphetamine

1031 EIA (EMIT)

Barbiturates 1031 EIA (EMIT)

Benzodiazepines 1031 EIA (EMIT)

Cannabinoids 1031 EIA (EMIT)

Cocaine 1031 EIA (EMIT)

Methadone 1031 EIA (EMIT)

Opiates 300 1031 EIA (EMIT)

Opiates 2,000 1031 EIA (EMIT)

Phencyclidine 1031 EIA (EMIT)

Propoxyphene 1031 EIA (EMIT)

Ethanol (quantitative) 1031 EIA (EMIT)




Quality Control

Bio-Rad Control Products

NOTE: Information in tables is subject to change; refer to vendor for latest information

Control Product Name Catalog Number Configuration Assays

Lyphochek Assayed Chemistry Control

L-1: C-310-5L-2: C-315-5

12 x 5 mL12 x 5 mL

ACPAlbAlkPALTAmyApoAApoBASTBilDBilTC3C4CaCarbChol

CKClCO2CreaDigGGTGluHaptIgAIgGIgMIronKLactLD

LipMgNaPhenoPhenyPhosTheoTIBCTPTRFTrigUreaUricVPA

Liquid Assayed Multiqual Chemistry Control

L-1: 694L-2: 695L-3: 696

12 x 3 mL12 x 3 mL12 x 3 mL

ACPAlbAlkPALTAmyApoAApoBASTBilDBilNBilTC3C4CaCarbCholCK

ClCO2CreaDigETOHGGTGluHaptHDLIgAIgGIgMIronKLactLD

LDLLipMgNaPAlbPhenoPhenyPhosTheoTIBCTPTRFTrigUreaUricVPA




Liquichek Pediatric Control L-1: 354L-2: 355

6 x 4 mL6 x 4 mL

BilDBilNBilTCa

ClGluK

MgNaTheo

Liquichek Ethanol/Ammonia Control

L-1: 544L-2: 545L-3: 546

6 x 3 mL6 x 3 mL6 x 3 mL

ETOH

Liquichek Spinal Fluid Control

L-1: 751L-2: 752

6 x 3 mL6 x 3 mL

AlbClGlu

IgAIgGIgM

LDNaTP

Liquichek Immunology Control

L-1: 591L-2: 592L-3: 593L-1: 594L-2: 595L-3: 596

6 x 1 mL6 x 1 mL6 x 1 mL6 x 3 mL6 x 3 mL6 x 3 mL

AlbApoAApoBC3C4

CRPHaptIgAIgGIgM

PAlbRFTPTRF

Liquichek Urine Chemistry Control

L-1: 397L-2: 398

12 x 10 mL12 x 10 mL

AmyCaClCreaGlu

KMgNaPhos

TPuAlbUreaUric

Lyphochek Quantitative Urine Control

L-1: 376L-2: 377

12 x 10 mL12 x 10 mL

BarbCaClCreaGlu

IronMgNaPhos

TPuAlbUreaUric

Liquichek Rheumatoid Factor Control

L-1: 501L-2: 502L-3: 503

6 x 2 mL6 x 2 mL6 x 2 mL

RFNOTE: Control means may shift at the end of shelf life and control ranges may need to be reestablished. Control Level 1 varies in concentration.

Recommendation: Do not use Level 1 if < 15 IU/mL.





Liquichek Qualitative Urine Toxicology Control

Negative: 454Positive: 455

6 x 3 mL6 x 3 mL

AmpMBarbBenz

CocETOHMeth

PCPPrpxTHC

Liquichek Immunology Plus Control

Trilevel: 360L-1: 361L-2: 362L-3: 363

12 x 5 mL (4 ea.)12 x 5 mL12 x 5 mL

CarbDigIron

PhenoPheny

TheoVPA

Liquichek Therapeutic Drug Monitoring Control

Trilevel: 724L-1: 725L-2: 726L-3: 727

12 x 5 mL12 x 5 mL12 x 5 mL

CarbDig

PhenoPheny

TheoVPA





Ordering Information

Commercial controls are available from several vendors.

NOTE: Analyte concentrations in commercial controls can vary from vendor to vendor and lot to lot.

Bio-Rad

Clinical Diagnostics(800) 2-BIORAD [(800) 224-6723]

Information(888) 5-BIORAD [(888) 524-6723]

Worldwide Webwww.bio-rad.com

NOTE: The Bio-Rad package insert includes the following statement for assignment of control values:

“The mean values printed in this insert were derived from replicate analyses and are specific for this lot of control. The tests listed were performed by the reagent manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of control. Individual laboratory means should fall within the corresponding acceptable range; however, the values listed may vary during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation, and reagents, or by manufacturer test method modifications. It is recommended that each laboratory establish its own means and acceptable range, and use those provided only as guides.”

Biochemical Diagnostics, Inc.

East Coast(800) 223-4835 or (631) [email protected]

West Coast(800) [email protected]

Worldwide Webwww.biochemicaldiagnostics.com




Establishing Quality Control Limits

Use the following instructions to establish quality control limits for Abbott Clinical Chemistry assays.

Temporary Quality Control Limits

1. Enter the assay parameters for the appropriate new assay.

2. Calibrate and run three replicates each of a multi-level control in a single run. Record the results on the Temporary Control Limits Worksheet at the end of this section. Do not discard any result unless it was generated by operator error or instrument malfunction, or results can be rejected as a statistical outlier.

3. Repeat the calibration and controls two more times for a total of three calibration and control runs (nine values for each control). Add fresh calibrators and controls to each analyzer cup for each new run.

4. Calculate the mean for each control level and record it on the worksheet. Multiply each mean by 0.20 and record the result (20% of the mean) on the worksheet.

5. Determine the temporary control limits for each control level (± 20% of each mean control concentration). For example, if the mean control concentration of Theophylline is 10 µg/mL, the control limits are 8 µg/mL (– 20%) and 12 µg/mL (+ 20%).

6. Use these temporary control limits when running patient samples. Test at least two levels of control every 24 hours, or more often as specified by the laboratory’s quality control program.

7. Use the following rules to determine if the run can be accepted.

a. If controls are within the temporary control limits, accept the run.

b. If any control is not within its control limits, rerun the control. If the control is within the control limits, accept the run.

c. If the control is still not within its control limits, reject the run. Recalibrate the assay. After recalibration, if the controls are within their control limits, test patient samples.




d. After calibration, if any control is not within its control limits, check control, calibrator, and reagent handling, then rerun the control. If the control is within its control limits after retesting, test patient samples.

8. Use the temporary limits until permanent control limits are established. Record and plot all routine control results on Levey-Jennings charts. These control results are used to determine the permanent control limits.

Permanent Control Limits

1. Start on the first testing day after temporary control limits were established; assay one aliquot each of two or more controls in a single run.

2. Use the following rules to determine if the run can be accepted.

a. If controls are within the temporary control limits, test patient samples.

b. If the control is still not within its control limits, reject the run and recalibrate. Run controls again. After recalibration, if the controls are within their control limits, accept the run.

c. If the control is still not within its control limits, reject the run then recalibrate. Run controls again. After recalibration, if the controls are within their control limits, accept the run.

d. If after recalibration the control is not within its control limits, check the control, calibrator, and reagent handling, then rerun the control. If the control is within its control limits after retesting, test patient samples.

3. Evaluate control results for 30 calendar days (a minimum of 20 values for control level) to determine the permanent control limits. Recalibrate whenever a control fails or every 14 calendar days. Record control results. Do not discard any result unless it was generated by operator error or instrument malfunction, or results can be rejected as a statistical outlier.




Temporary Control Limits Worksheet

Assay Name:_______________________________________________ Lot#: _______________________Exp. Date: _________________________________________________ Lot#: _______________________Control 1: _________________________________________________ Lot#: _______________________Control 2: _________________________________________________ Lot#: _______________________Control 3: _________________________________________________ Lot#: _______________________

Temporary control limits accepted by:

Name: ____________________________________________________ Date: _______________________

Calibration/Accepted by Replicate Control 1 Control 2 Control 3

1 1

by: 2

3

2 1

by: 2

3

3 1

by: 2

3

Mean (x)

20% of Mean(x) (0.20)

Lower Limit(x – 20%)

Upper Limit(x + 20%)




Reagent Test Count Tracking

Reagent Test Counts

The AEROSET System performs a level sense in the reagent cartridge and calculates the remaining volume of reagent. The dead volume (based on the height of the low aspiration limit) and the configured reagent volume plus over-aspiration is subtracted from the reagent volume; remaining volume is calculated as the number of tests remaining.

When a reagent cartridge is configured for two different assays, the number of tests is divided by two and the volume displays for both assays. For example, assays with both a serum and urine application, such as Glucose and Creatinine, use the same reagent cartridge but have different assay numbers. The total number of tests is divided by two—half for the serum assay and half for the urine assay.

In-house studies have validated the number of estimated tests per kit, included in the assay-specific Abbott Clinical Chemistry Package Inserts. However, the test count displayed on the REAGENTS screen is not always correct.

Example: the Glucose package insert claims an estimated tests per kit of 3,770 (3,770 divided by 10 kits = 377 tests per cartridge). In our studies, the number of tests left per cartridge after the first calibration showed R1 = 223 and R2 = 176 when both should have been 368 [377 – 9 (3 calibrator levels at 3 replicates)]. Despite the displayed volume, 377 tests were performed before an empty reagent error was generated.




Sample Blanking

Self Blank vs. Non-Self Blank

Self Blank

The blank is done in the same cuvette as assay measurement. It is typically done with R1 and sample immediately before R2 is added. On the Base page of the Assay Configuration screen, in the Sample Blank Test field, you must select the same assay name as the assay you are configuring, then a Blank Read Time must be defined. The absorbance value measured during the Blank Read Time is corrected for the sample/reagent dilution ratio, then is subtracted from the absorbance value measured during the Main Read Time. If the Blank Read Time is defined after the addition of R2, the absorbance value is not corrected for the dilution ratio.

Non-Self Blank

A separate assay parameter file is defined to measure the blank reading. All parameters must be defined as if it was a “stand-alone” assay. This stand-alone blank assay should have nothing selected in the Sample Blank Test field or in the Blank Read Time field. For example, for the blank test, you could use saline or water, and sample. On the Base page of the Assay Configuration screen of the assay to be blanked, you must select the assay name of the configured blank assay in the Sample Blank Test field. The Blank Read Time fields must remain zero. When the assay is ordered, the AEROSET System dispenses the sample and reagent defined in the assay configuration into one cuvette and dispenses the sample and reagent defined in the blank configuration into another cuvette. They are treated as two separate tests to be dispensed and measured. When measurement is completed, the system subtracts the absorbance value measured during the Main Read Time of the blank assay from the absorbance value measured during the Main Read Time of the assay.




Sample Interference IndicesThe Sample Interference Indices Protocol is available on the AEROSET Assay Disk, Assays > 50 (LN 2K15 and 2K16). This feature allows semi-quantitative or qualitative estimates (index values) for the presence of hemolysis, icterus, or lipemia (turbidity) in serum or plasma samples.

The AEROSET System uses specific wavelength combinations to measure absorbance of hemolysis, icterus, and lipemia. The absorbance data are converted to semi-quantitative values according to the specific formulas defined in the assay parameters. The operator can choose between semi-quantitative (i.e., Index units) or qualitative (0, 1+, 2+, 3+, 4+) results format.

To estimate hemolysis, icterus, and lipemia on a sample, a reference photometric assay file must be configured. To configure this file, the operator must define which reagent (saline, ALT, or AST) to use for the analysis.

Package inserts are available for both the Saline and the ALT/AST Protocols to run the Sample Interference Indices.

Sample Interference Indices are used to observe the color of a sample that is due to hemolysis, icterus, and lipemia. The indices measurement is performed on each sample, not each assay.

Sample Interference Indices report the presence of hemolysis, icterus, and lipemia. These values are not used to correct results, but to indicate when assay results should be evaluated. To correct results for interferences, the Self or Non-Self Blank options are used.




SmartWash™

SmartWash (Reagent Carryover) When Moving A and B-Line Assays

When the AEROSET Assay/Configuration Disks are loaded, A and B-Line definition is complete. Throughput is maximized while minimizing the possibility of reagent carryover when defining the A and B-Line assays.

If an operator needs to change the assay configuration and move an A-Line assay to the B-Line (or B to A) to improve throughput, they must consider how this would affect the reagent carryover (SmartWash).

Things to consider:

1. When an assay is defined in the B-Line, the SmartWash page only allows selection of a reagent probe wash with other assays in the B-Line. These reagent probe washes are defined for the Abbott assays. If the assay is moved to the A-Line, the assay may be affected by carryover from an assay in the A-Line. Refer to the assay-specific or Abbott Clinical Chemistry Package Inserts and the following table to define any probe washes needed for A-Line and B-Line assays.

2. Some assays should not be configured for the same line; it is not possible to ensure sufficient washing to eliminate reagent carryover.

The following assays should not be positioned on the same line as Lipase:

• Calcium

• Urine Calcium

• Cholesterol

• CO2

• Triglyceride

• Uric Acid

• MULTIGENT® Direct LDL




SmartWash™ Parameters

When a SmartWash is configured for the reagent probe, the AEROSET System attempts to schedule the assay so the two assays are separated by another reagent, maximizing throughput and eliminating need for the wash.

NOTE: If the interfering and affected assays are both two-reagent assays (R1 and R2) and the assay that separates the interfering and affected assay uses one reagent (R1) only:

• SmartWash is not performed for the R2 reagent

• An extra “routine” water rinse is performed for R2

If the interfering assay is followed by the affected assay, the reagent probe aspirates the required volume of wash solution to clean the probe between the assays, and dispenses wash solution into an empty cuvette to also clean the mixer(s). An extra cuvette is used for this procedure.

When a SmartWash is configured for the reaction cuvette, wash solution is added to the cuvette to minimize reagent interference. This decreases the assay throughput from extra time spent washing the reaction cuvette.

When a SmartWash is configured for the sample probe, the probe is washed immediately before aspirating the sample, delaying throughput by one cycle.

SmartWash for Non-Abbott Reagent Applications

It is the customer’s responsibility to determine possible reagent carryover and SmartWash required for non-Abbott reagent applications. Refer to Reagent Carryover in Section 2, Installation Requirements and Special Procedures of the AEROSET System Operations Manual.




Specific Proteins AssaysThe Abbott Clinical Chemistry Specific Proteins menu includes Apolipoprotein A1 and B; Complement C3 and C4; Haptoglobin; Immunoglobulin A, G, and M; Prealbumin; and Transferrin.

Imprecision

• The R2 component of two-reagent assay contain the active ingredient

• R2 dispense and mixing drives the reaction

• When troubleshooting precision concerns, verify R2 mixer alignment and function, R2 reagent probe dispense and position, and proper installation of R2 reagent syringe seal tips and O-ring.

Bar Code Read Errors

• Round bottles may rotate slightly in adapters when the Reagent Carousel rotates, moving the bar code label and affecting the ability of the bar code scanner to read the bar code label.

– Turn the reagent bottle toward the center of the Reagent Carousel to allow the bar code scanner to read the bar code label.

– Insert the bottle from the bottom of the adapter so the bar code label is not scraped.

• Reagent bottles may fit tightly in some adapters. Frequent reloading and removal of bottles may damage the bar code label.




)

Frequently Asked Questions (FAQ)

Question Response

Why are linearity claims only up to the highest calibrator?

• Non-linear assays (C3, C4, Hapt, IgA, IgG, IgM, and TRF): accuracy by recovery cannot be guaranteed beyond the highest calibrator. The AEROSET System uses %EXT to prevent extrapolation.

• Linear assays (ApoA, ApoB, and PAlb): accuracy above the highest calibrator is dependant on calibrator concentrations, which vary from lot to lot. The AEROSET System uses %EXT to prevent extrapolation. Although R&D testing supports linearity beyond the highest calibrator, linearity was defined up to the high calibrator. Data from a large cohort of samples indicate very few samples will exceed the highest calibrator concentration.

Why are calibration modes for ApoA, ApoB, and PAlb linear if the calibration curves are not straight?

Although the graphs appear non-linear for these assays, the calibrations approximate a linear response close enough to ensure accurate results across the calibration range. Therefore, the calibration modes were defined as linear for each of these assays.

When the Specific Proteins assays were originally launched for the AEROSET System, only two levels of controls were run for precision. Why are three levels of controls now included for precision?

• Commercial trilevel controls were used for the ARCHITECT® c 8000® precision testing. The Level 3 control is approximately the same concentration as the Level 2 control used in original AEROSET testing.

• The revised package inserts now include a combination of AEROSET and/or c 8000 data. The data were selected based on the highest total %CV for each control level, independent of the instrument on which they were tested.




When a manual dilution is performed for the IgA and IgM assays, what value should be entered for the sample dilution?

Enter the manual dilution factor only. The system automatically adjusts for use of a standard sample dilution.Example: a manual 1:4 dilution is prepared and tested using the standard sample dilution (1:5). Enter 4 for the manual dilution; the system automatically multiplies the measured concentration by 20 (manual dilution × standard sample dilution) to determine the result.

Why are the linear low and LOQ different values?

• LOQ is the lowest analyte concentration at which %CV = 20.

• Some Specific Proteins assays become increasingly inaccurate as analyte concentrations drop below the lowest calibrator and approach the LOQ. For this reason, the linear low limits for these assays are based on accuracy by recovery studies, not LOQ studies.

When running the IgA or IgM assay, and an LH Result Error Code occurs, what should the customer do?

The sample should be diluted and rerun. An automated dilution can be performed using Dil 2.

When running the IgA or IgM assay, and an LL Result Error Code occurs, what should the customer do?

The sample should be rerun undiluted. An automated dilution can be performed using Dil 1.

Frequently Asked Questions (FAQ) (Continued)

Question Response




Specimen Collection and HandlingIn the SPECIMEN COLLECTION AND HANDLING section of the package inserts, many state: “Separate from red blood cells as soon after collection as possible”.

To clarify a reasonable time period for “as soon as possible”, Tietz Textbook of Clinical Chemistry, 2nd ed. uses the same verbiage but adds “..., and certainly within two hours”.

Reference: Laessig RH, et al. Changes in serum chemical values as a result of prolonged contact with the clot. Am J Clin Pathol 1986 Mon;66(#):598–604.

Serum should be separated within two hours of collection, and prolonged contact of serum with the clot will affect potassium, glucose, and ammonia results.

Reference: McClatchey KD, editor. Clinical Laboratory Medicine, 1st ed. Philadelphia, PA: Lippincott, Williams, and Wilkins, 1994:85.




Therapeutic Drug Monitoring (TDM) AssaysThe Abbott Clinical Chemistry Therapeutic Drug Monitoring (TDM) menu includes Carbamazepine, Phenobarbital, Phenytoin, and Theophylline.

Calibration

• A full calibration is required with each reagent cartridge change and each change in reagent lot number.

• CAL 1 must always be used as the blank. Do not use water to calibrate.

• A Blank Adjustment calibration using CAL 1 is required once each day of assay use, unless a full calibration is performed.

• To obtain recommended volume requirements for the Abbott TDM calibrators, hold the bottles vertically and dispense two drops (50 µL) of each calibrator into each respective sample cup.

Troubleshooting Tips

The following issues may impact TDM assay results:

• Crimped tubing

• Flared tubing—reagent probes

• Wash flow rates for reagent and sample probes

• Cuvette dryer tip tubing disconnected





Question Response

Why are Phenytoin precision data from only two instruments included in the package insert?

Because of instrument issues, data from only two instruments will be included in the package insert but additional studies are being performed for inclusion at a later date.

Why are AEROSET precision data different than the c 8000® precision data presented?

Precision was performed for all four TDM assays at the same time on both the c 8000 and AEROSET Systems. Testing was repeated on the AEROSET for all four assays because of additional requirements for a daily blank calibration and calibration with each new wedge.

Why is it now necessary to calibrate with each new reagent cartridge?

It is necessary to recalibrate with each new cartridge to optimize performance, and to achieve 28 days reagent onboard stability and 14 days calibration stability. Also, this eliminates the need to recap reagent cartridges and place them back in the refrigerator, which is necessary with other vendor products, such as Olympus.

How is Abbott’s precision claim determined? Abbott’s package insert claim for total precision is CV < 7% for Carbamazepine and Phenobarbital, and CV < 8% for Phenytoin and Theophylline. These are based on initial product requirements used in product development. The validation and verification testing demonstrated total precision of less than 7%. Representative data are included in the package insert.

What is the benefit of running a blank calibration (using CAL 1) once each day of assay use?

It provides an additional level of robustness to assay performance.

Why was the method comparison data changed from the previous package insert?

Slope, correlation coefficient, and Y-intercept were recalculated using least squares regression; this aligns with the method used to calculate c 8000 data.

Was there a change to the TDM onboard stability?

Yes, changes were made to provide an additional level of robustness to onboard stability.




Why is Phenytoin compared to high-performance liquid chromatography (HPLC) methodology, but not the other TDM assays?

HPLC is commonly considered the gold standard in immunoassay. Phenytoin is extensively metabolized and the major pathway is para-hydroxylation of the phenyl ring. The resulting metabolite, p-hydroxyphenytoin (HPPH) is inactive and present largely as a glucuronide conjugate (HPPG). Both metabolites are structurally similar to phenytoin, and may interfere with immunoassays. This is especially true in renal insufficiency, where HPPG clearance is decreased and plasma levels of HPPG may be increased 10 times the phenytoin concentration.


Question Response




Verification Procedures

Confirming the Limit of Detection (LOD)

The Limit of Detection (LOD) represents the noise associated with the analytical system in the absence of analyte. The LOD is determined by analyzing a zero concentration sample (saline or equivalent zero level material and adding two standard deviations (SD) to the mean of the results. The LOD is the mean concentration of an analyte-free sample + 2 SD, where SD equals the pooled, within-run standard deviation of the analyte-free sample.

Before performing the study, the following conditions must be met:

• Maintenance procedures are up to date.

• Reagent and samples are available in sufficient quantity.

• Assays are calibrated.

• All control levels are in range.




Procedure1. Prepare one blank level for each assay to be tested.

2. Select <Database> in the Information Access Area of the Main Display. The DATABASE screen displays.

3. Select <Order> in the right column of the screen. The Order Samples screen displays. If this is not the first sample ordered, select <New>.

4. Enter the following information:

• Name or SID

• C/P

• Replicates (5)

5. Select the assay(s) to be evaluated.

6. Select <Copy> in the right column of the Order Samples screen. The Copy Order dialog window displays.

7. Enter 1 in the How Many Copies? field to request one copy (N = 10, 2 samples × 5 replicates) then select <OK>. The Order Samples screen displays.

8. Load the sample(s) in the designated C/P.

9. Select <OK> in the right column of the screen.

10. Select <RUN> in the Action Area of the Main Display. The RUN OPTIONS screen displays.

11. Select the Patient option (�).

12. Select <Start> in the right column of the RUN OPTIONS screen to initiate the run.




Limit of Detection for Abbott Assays Data Sheet

Date: _____________ Analyte: ___________________________________________________________Instrument: ___________________________________________ Serial No.: ______________________

Record the values for the zero concentration sample replicates.

Calculate the limit of detection.

Comments: ____________________________________________________________________________________________________________________________________________________________________Technologist: _____________________________________________ Date: _______________________ Reviewed by: _____________________________________________ Date: _______________________

Lot Number Expiration Date

Reagent Kit

Calibrators

Replicate Value

1

2

3

4

5

6

7

8

9

10

A. Determine the mean of the replicates: Mean* = __________________

B. Determine the SD of the replicates: SD = __________________

C. Multiply the SD by 2: 2 × SD = __________________

D. Add line A and line C: Mean + (2 × SD) = __________________

* If the calculated mean is � 0, enter 0 as the mean.

Data Summary Calculated Value Expected Value

Limit of Detection




Limit of Detection for Abbott Assays Data Sheet Example

Date: 3/11/03 Analyte: ABC Instrument: AEROSET System Serial No.: 1243

Record the values for the zero concentration sample replicates.

Calculate the limit of detection.

Comments: Confirmed limit of detection _______________________________________________________________________________________

Technologist: (Name) Date: 3/11/03 Reviewed by: (Name) Date: 3/11/03


Reagent Kit 334455MB 07/07/03

Calibrators 50383 05/01/03

Replicate Value

1 0.05

2 0.05

3 0.03

4 0.04

5 0.02

6 0.06

7 0.03

8 0.02

9 0.10

10 0.02

A. Determine the mean of the replicates: Mean* = 0.04

B. Determine the SD of the replicates: SD = 0.02

C. Multiply the SD by 2: 2 × SD = 0.04

D. Add line A and line C: Mean + (2 × SD) = 0.08

* If the calculated mean is � 0, enter 0 as the mean.


Limit of Detection 0.08 0.12




Confirming the Limit of Quantitation (LOQ)

The Limit of Quantitation (LOQ) represents the analyte concentration corresponding to a coefficient of variation (CV) of 20%. This is considered the functional sensitivity of an assay.

Before performing the study, the following conditions must be met:

• Maintenance procedures are up to date.

• Reagent and samples are available in sufficient quantity.

• Assays are calibrated.

• All control levels are in range.

Procedure1. Prepare the low analyte sample for each assay to be tested.

Review the reagent package insert for the LOQ. Dilute the first or second non-zero calibrator to the approximate concentration of the LOQ stated in the insert. For example, the LOQ for AEROSET Carbamazepine is 0.5 µg/mL. The Level 2 calibrator (first non-zero calibrator) contains 2.0 µg/mL of analyte. The following dilution can be prepared:

1:4 dilution of the Level 2 calibrator, resulting in a 0.5 µg/mL sample for testing

2. Select <Database> in the Information Access Area of the Main Display. The DATABASE screen displays.

3. Select <Order> in the right column of the screen. The Order Samples screen displays. If this is not the first sample ordered, select <New>.

4. Enter the following information:

• Name or SID

• C/P

• Replicates (5)

5. Select the assay(s) to be evaluated.

6. Select <Copy> in the right column of the Order Samples screen. The Copy Order dialog window displays.

7. Enter 1 in the How Many Copies? field to request one copy (N = 10, 2 samples × 5 replicates) then select <OK>. The Order Samples screen displays.




8. Load the sample(s) in the designated C/P.

9. Select <OK> in the right column of the screen.


11. Select the Patient option (�).

12. Select <Start> in the right column of the RUN OPTIONS screen to initiate the run.




Limit of Quantitation for Abbott Assays Data Sheet

Date: _____________ Analyte: ___________________________________________________________Instrument: ___________________________________________ Serial No.: ______________________

Record the values for the low analyte sample replicates.

Calculate the limit of quantitation.

Comments: ____________________________________________________________________________________________________________________________________________________________________Technologist: _____________________________________________ Date: ________________________Reviewed by: _____________________________________________ Date: _______________________


Reagent Kit

Calibrators

Replicate Value

1

2

3

4

5

6

7

8

9

10

A. Determine the mean of the replicates: Mean = __________________

B. Determine the SD of the replicates: SD = __________________

C. Determine the %CV of the replicates: %CV = __________________


Limit of Quantitation

SD

Mean× 100%CV =




Limit of Quantitation for Abbott Assays Data Sheet Example

Date: 3/11/03 Analyte: ABC Instrument: AEROSET System Serial No.: 1243

Record the values for the low analyte sample replicates.

Calculate the limit of quantitation.

Comments: Confirmed limit of quantitation _______________________________________________________________________________________

Technologist: (Name) Date: 3/11/03 Reviewed by: (Name) Date: 3/11/03


Reagent Kit 334455MB 07/07/03

Calibrators 50383 05/01/03

Replicate Value

1 0.25

2 0.25

3 0.25

4 0.23

5 0.20

6 0.26

7 0.24

8 0.35

9 0.35

10 0.25

A. Determine the mean of the replicates: Mean = 0.26

B. Determine the SD of the replicates: SD = 0.0481

C. Determine the %CV of the sample: %CV = 18.5


Limit of Quantitation 18.5% 20.0%

SD

Mean× 100%CV =




NOTES




Assay-specific Information

Acid Phosphatase

Method Comparison

The Abbott Clinical Chemistry Acid Phosphatase (ACP) assay compares well to some other assays and not as well to others. Review of CAP proficiency testing survey results indicates the degree of comparability that can be expected. For two survey specimens, the mean values are listed in the following table.

Array and AEROSET values for ACP agree with each other, as do the Vitros and Paramax, but the Array/AEROSET do not agree with Vitros/Paramax. ACP values for three other CAP specimens tested by Paramax and AEROSET demonstrate similar disparity (1.93, 10.85, and 7.73 U/L by Paramax; 5.67, 40.39, 29.19 U/L by AEROSET).

Method comparison data for AEROSET and Paramax yielded the following least squares equation:

AEROSET = 3.61 (Paramax) - 2.96, r = 0.992, N = 78

When the same data were analyzed using Passing-Bablok, the equation was:

AEROSET = 2.86 (Paramax) - 1.59, r = 0.992, N = 78

Instrument Specimen 1 (U/L) Specimen 2 (U/L)

Array 1.55 19.78

AEROSET 1.66 21.70

Paramax 0.44 5.57

Vitros 0.65 5.55




Although Paramax and AEROSET assays definitely correlate (as shown by the r value), a specimen tested on the AEROSET will yield a value approximately three times greater than that obtained by the Paramax System. The Paramax uses alpha-naphthylphosphatase as the substrate for the ACP reaction, as does the AEROSET and Vitros (Array substrate unavailable). Despite the use of the same substrate and generally similar reaction schemes, different reagents do not yield similar results. The Paramax employs a solid tablet reagent format, the Vitros a unique dry (damp) slide format, and the Array and AEROSET both use liquid reagents. The exact content of all of these reagents is not known, this is proprietary information. Given the many factors affecting ACP analysis, such as heterogeneity of the enzyme (different isozymes are found in liver, spleen, erythrocytes, prostate, etc.), differences in conditions for optimal activity of these isozymes (pH, inhibitors, etc.), need to maintain an acidic environment to stabilize and preserve ACP activity (addition of an acidifying solution to serum specimens after collection), and the variety of different reagent formulations that exists, it is not surprising that roughly equivalent results are not obtained when the same specimens are tested using kits from different vendors.




Albumin BCG

Calibrators

Do not use Multiconstituent Calibrator CAL 1 (MCC 1) for calibration. Use MCC 2 for both CAL 1 and 2. The AEROSET System automatically dilutes MCC CAL 2 for CAL 1.

Observed Problem

Alkaline Phosphatase

Observed Problem

Illegal assay configuration

Probable Cause(s) Corrective Action(s)

Diluent not configured. Ensure new assay parameters are installed. (Diluent is now necessary for calibration; refer to Revision 3 or greater of the package insert.) Refer to Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual.

RL% Result Error Code


R2 reagent probe is out of alignment. Adjust the R2 reagent arm. Refer to Reagent Arm Adjustment in the Hardware section of this guide.




ALT

Ammonium Heparin Tube Not Acceptable

Ammonium heparin was removed from the list of approved anticoagulants for ALT, ALT-A, AST, and AST-A. The reference used to support this recommendation is Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry, 2nd ed. Philadelphia, PA: WB Saunders, 1994:795.

This reference states:

“Elevated levels of L-GLD (EC 1.4.1.3) may be encountered in some sera from patients with parenchymal liver disease. If ammonia is also present in the serum specimen or in one of the reagents, the GLD reaction will proceed and interfere with the AST determination by consuming oxoglutarate and NADH. Thus, use of ammonia-free reagents is recommended.”

ALT/AST Activated Versus ALT/AST

Differences

ALT Activated and AST Activated assays contain the coenzyme (activator) pyridoxal-5-phosphate (P-5-P); ALT and AST assays do not contain P-5-P. Most laboratories in the U.S. prefer non-activated formulations, while use of activated assays is prevalent in European laboratories. The IVD Directive is encouraging laboratories to use activated forms of the reagent.

There is no difference in reaction, and there are minimal differences with most patient results. The activated reagent is useful in patients with nutritional deficiencies, where the coenzyme P-5-P level may be decreased with resultant decreased enzyme activity. With these patients, the activated reagent provides an advantage because it activates enzymes that may not otherwise be fully active if the patient has a P-5-P deficiency.

However, ALT Activated and AST Activated assays require reconstitution, and have shorter onboard stability than the non-activated assays—seven days vs. 27 days.

ALT Activated


Refer to ALT in this section for details.





Cross Reactivity Testing Performed on the AEROSET System by SYVA

Compounds listed in the following table yielded a negative result at 1,000 ng/mL d-methamphetamine (Multi DOA Cutoff calibrator) when tested at the concentration listed.

Compound SYVA Package Insert µg/mL

Acetaminophen 1,000

Acetylsalicylic acid 1,000

Alpha-acetyl-N, N-dinormethadol (dinor LAAM)

25

l-Alpha-acetylmethodol (LAAM) 25

Buprenorphine 100

Caffeine 1,000

Clomipramine 2.5

Clonidine 1,000

Codeine 500

Cotinine 100

Cyclobenzaprine 28

Doxepin 10

Glutethimide 500

Ketamine 100

Lysergic acid diethylamide (LSD) 10 ng/mL

Meperidine 1,000

Phenytoin 1,000

Tramadol 100

Zidovudine (AZT) 2 mg/mL

Zolpidem 100




Amylase

Interference Information

Icodextrin, a complex carbohydrate contained in some fluids used for peritoneal dialysis, has been reported to interfere with amylase assays. Low amylase values may be obtained due to inhibition of amylase activity by icodextrin. No testing has yet been conducted for the specific amylase method used on the AEROSET System. In addition, the mechanism of the reported amylase inhibition may not affect all amylase assays. Until specific information is available for the AEROSET, amylase results from patients receiving peritoneal dialysis must be assessed in relation to their clinical condition and exposure to icodextrin.

Wang G, Leesch V, Turner P, Moberly JB, Martis L. Kinetic analysis of icodextrin interference with serum amylase assays, Adv Perit Dial 2002;18:96–99.

Anderstam B, Garcia-Lopez E, Heimburger O, Lindholm B. Determination of alpha-amylase activity in serum and dialysate from patients using icodextrin-based peritoneal dialysis fluid, Perit Dial Int 2003;23:146–50.




Apolipoprotein A1

Observed Problems

Falsely lowered results near the concentration of CAL 1


Apo Al/Apo B calibrator not prepared correctly.

Prepare calibrators correctly:• Reconstitute with 1.0 mL Type II water.• Allow to stand for 10 minutes.• Dissolve by swirling—do not shake.• Prepare the four calibrator dilutions using

the reconstituted calibrator and diluent.

LH Result Error Code observed when result is less than the highest calibrator


Linear Range-H field not edited to high calibrator concentration.

Edit the Linear Range-H field to the high calibrator concentration (as stated in the calibrator value sheet).

Poor precision or erroneous results


R2 reagent arm is out of alignment. Adjust the R2 reagent arm. Refer to Reagent Arm Adjustment in the Hardware section of this guide.

R2 reagent is not dispensed correctly. • Check R2 dispense components (sample or reagent probe, syringes, wash, mixer, tubing).

• Check the reagent cartridge for bubbles or foam. If present, remove with an applicator stick; use a new applicator stick for each cartridge.

• Check reagent adapters to verify they are seated properly.

Reagent container bar code label not read


Bar code label not positioned correctly.

Check positioning of the R1 and R2 reagent bottles; verify the bar code label is facing the center of the carousel.




Apolipoprotein B

Observed Problems

Falsely lowered results near the concentration of CAL 1


Apo Al/Apo B calibrator not prepared correctly.

Prepare calibrators correctly:• Reconstitute with 1.0 mL Type II water.• Allow to stand for 10 minutes.• Dissolve by swirling—do not shake.• Prepare the four calibrator dilutions using

the reconstituted calibrator and diluent.


















AST



AST Activated



Observed Problem

Results within normal range are flagged with LL Result Error Code


The L-Linear Range parameter was edited in the updated assay parameter file, from the Limit of Detection (LOD) value of 2.8 U/L to the Limit of Quantitation (LOQ) value of 7.8 U/L. The LOQ value is rounded up to the number of decimal places defined in the Decimal Places field, and results with a value < 8 U/L are flagged with a LL Result Error Code.

NOTE: LOQ was chosen as the lower limit because it represents the lowest limit at which quantitative information is reliable (%CV = 20), rather than using the LOD which represents the noise associated with the analytical system in the absence of analyte. An in-house normal range study is planned.

If a report with a result < 8 U/L (no LL Result Error Code) is desired, an alternate method should be used.




Barbiturates


Compounds listed in the following table yielded a negative result at 200 ng/mL secobarbital (Multi DOA Cutoff calibrator) when tested at the concentration listed.


Acetaminophen 1,000

N-Acetylprocainamide (NAPA) 400


Alpha-acetyl-N, N-dinormethadol (dinor LAAM)

25


Amitriptyline 1,000

Buprenorphine 100

Caffeine 1,000

Cimetidine 1,000

Clomipramine 2.5

Clonidine 1,000

Codeine 500

Cotinine 100

Cyclobenzaprine 28

Desipramine 800

Diphenhydramine 1,000

Doxepin 10

2-Ethylidene-1,5-dimethyl-3, 3-diphenylpyrrolidine (EDDP)

1,000

Fluoxetine 500

Ibuprofen 1,000

Ketamine 100

Ketorolac tromethamine 1,000


Meperidine 1,000

Naproxen 1,000




Nortriptyline 750

Promethazine 1,000

Ranitidine 900

Scopolamine 500

Tramadol 100

Tyramine 100


Zolpidem 100





Benzodiazepines


Compounds listed in the following table yielded a result approximately equivalent to the Multi DOA Cutoff calibrator (200 ng/mL lormetazepam).

Compounds listed in the following table yielded a negative result at 200 ng/mL lormetazepam (Multi DOA Cutoff calibrator) when tested at the concentration listed.

Compound Concentration Calculated ng/mL

SYVA Package Insert ng/mL

7-aminoflunitrazepam 341 295

CompoundSYVA Package Insert

µg/mL (Tested at 150 ng/mL Cutoff)

Acetaminophen 1,000



Alpha-acetyl-N, N-dinormethadol(dinor LAAM)

25


Amitriptyline 1,000

Buprenorphine 100

Caffeine 1,000

Cimetidine 1,000

Clomipramine 2.5

Clonidine 1,000

Codeine 500

Cotinine 100

Cyclobenzaprine 28

Desipramine 800


Doxepin 10


1,000




Fluoxetine 500

Glutethimide 500

Ketamine 100



Meperidine 1,000

Nortriptyline 750

Phenytoin 1,000

Promethazine 1,000

Ranitidine 900

Scopolamine 500

Thioridazine 100

Tramadol 100

Tyramine 100


Zolpidem 100






Calcium

Observed Problem

LOD/LOQ claim not duplicated by customer


Reagent cross contamination.NOTE: Creatinine contaminates Calcium at very low levels, even with SmartWash™ configured. The contamination is not clinically significant.

Run Calcium in batch mode for LOD/LOQ testing.




Cannabinoids


Compounds listed in the following table yielded a negative result at 50 ng/mL 11-nor-∆9-THC-9-carboxylic acid (Multi DOA Cutoff calibrator) when tested at the concentration listed.


Acetaminophen 1,000



25


Buprenorphine 100

Caffeine 1,000

Cimetidine 1,000

Clomipramine 2.5

Clonidine 1,000

Codeine 500

Cotinine 100

Cyclobenzaprine 28

Desipramine 800


Doxepin 10


1,000

Fluoxetine 500

Glutethimide 300

Ibuprofen 1,000

Ketamine 100



Naproxen 1,000

Nortriptyline 750

Phenytoin 1,000




Troubleshooting Imprecision

Imprecision on the Cannabinoids assay can be the result of:

• Crimped tubing, especially at the cuvette wash station

• Incomplete cuvette wash

Certain types of plastics adsorb cannabinoids (THC) from solutions, decreasing the concentration. Observe the following guidelines to prevent adsorption.

• AEROSET sample cups should be filled with 600 µL of calibrator, control, or specimen to minimize the surface-to-volume ratio.

• Do not use disposable polyethylene transfer pipettes to dispense calibrators, controls, or specimens.

• Do not redispense solutions from a pipette back into a calibrator, control, or specimen container (includes redispensing after wetting a pipette tip).

• Immerse the pipette tips below the surface of the liquid only far enough to aspirate the needed volume; this minimizes contact of the pipette tip with calibrator, control, or specimen.

Ranitidine 900

Scopolamine 500

Thioridazine 100

Tramadol 100

Tyramine 100


Zolpidem 100





Cocaine


Compounds listed in the following table yielded a negative result at 300 ng/mL benzoylecgonine (Multi DOA Cutoff calibrator) when tested at the concentration listed.





25


Buprenorphine 100

Caffeine 1,000

Cimetidine 1,000

Clomipramine 2.5

Clonidine 1,000

Codeine 500

Cotinine 100

Cyclobenzaprine 28

Desipramine 800


Doxepin 10


1,000

Fluoxetine 500

Glutethimide 500

Ibuprofen 1,000

Ketamine 100



Meperidine 1,000

Naproxen 1,000

Nortriptyline 750

Phenytoin 1,000




Promethazine 1,000

Ranitidine 900

Scopolamine 500

Thioridazine 100

Tramadol 100

Tyramine 100


Zolpidem 100






Complement C3

Observed Problems


















Complement C4

Observed Problems


















C-Reactive ProteinBefore troubleshooting the CRP assay, ensure the assay parameters were configured correctly. Do not install the CRP assay using assay parameters on the Import Disk—Serum Proteins Version 1.0.

Standard Material Recovery

Recovery accuracy results of the standard material are summarized in the following table.

Assay Standard Material N Units Expected

ValueRecovered

(Mean) Value %Recovery

CRP (LN 8G65)

CRM 470 4 IU/mL 203.72 213.14 104.62

4 IU/mL 105.73 115.62 109.35

4 IU/mL 50.93 52.47 103.02

4 IU/mL 26.43 27.19 102.87


Question Answer

The LOQ claim is 0.50 mg/dL in the CRP package insert. The insert also states that a study was performed on the AEROSET and ARCHITECT® c 8000® Systems, which resulted in an LOQ of 0.25 mg/dL. Where did the LOQ claim of 0.50 mg/dL originate?

The LOQ study yielded representative data of 0.25 mg/dL (worst case result observed). The claim of 0.50 mg/dL is the Product Requirement, minimum acceptable performance, which was determined before performing the LOQ study.Product claims are based on product requirements which Abbott Laboratories determines from literature, customer feedback, and other sources of information. Actual product performance “typical results” may perform better than the claim.

In the package insert, why is there is a serum reference range but not a plasma reference range?

The reference range study was performed with only serum specimens to confirm the literature reference, which also used only serum specimens.A separate reference study with plasma specimens was not performed.




The CRP R2 reagent contains latex microparticles. Is inversion of R2 reagent required before every run to ensure the particles do not settle?

Inversion is not required before running the test. The latex microparticles are very small and remain suspended after the R2 cartridge is initially inverted and placed on the Reagent Carousel.Although a specific study was not performed, we suspect the carousel movement keeps the microparticles suspended.

How much control variability should be observed between reagent lots of the CRP assay?

The CRP assay was tested with a minimum of three lots. These lots included freshly prepared reagent, and one nearing the expiration date. Minimal variability in controls was observed. Control ranges (also called Action Limits) were not reset with a change in reagent lot.

How would results be affected if reagent kits are inadvertently frozen during delivery? The package insert does not address this issue.

The customer should check QC performance. Freeze/thaw studies by the OEM supplier support acceptable performance with frozen material.

Will customers have an issue if there are not enough Abbott assay users when results from a proficiency survey are compared to other manufacturers’ CRP assays?

OPEN QUESTION – Under evaluation.We do not have data for this. However, CAP Proficiency Survey specimens were recently run at Abbott, as they are for all on-market products. We will review the results and communicate them internally when published by CAP.

Were gel barrier tubes tested for use with the CRP assay?

A study has not yet been performed with gel barrier tubes. However, this will be considered for a future study.

If CRP is not inverted before use, what errors are observed?

A specific study has not been performed. However, if latex particles have settled to the bottom of the reagent cartridge and are not pipetted, it is possible that low absorbance values could be observed.

Is the Hitachi method for CRP a turbidimetric method?

Boehringer Mannheim reagents for use on Hitachi instruments are described in the BM package inserts as “immunological agglutination” which is a turbidimetric method.


Question Answer




Is the assay number for the new CRP assay the same as the original CRP assay?

Yes. However, this it not an issue because the “original” CRP assay was never released to customers.A new Import Disk—Serum Proteins Version 2.0 was released with the new CRP assay.

Conv Units SI UnitsOld Import Disk LN 4E43-03 4E43-06New Import Disk LN 2K89-02 2K90-02

Why does the RF assay have a Reaction Check programmed but the CRP assay does not?

The shape of the RF progress curve allows for use of the Reaction Check feature. At concentrations > 30 mg/dL, the CRP progress curve does not demonstrate enough difference in Read Times A & B for the Reaction Check flag to detect each occurrence. However, it was verified that the EXT and High flags work appropriately with CRP.

Why do AEROSET CRP control means listed in the Precision section of the package insert not match those for c 8000®?

Precision studies for the AEROSET and c 8000 Systems were done at different times with different lots of control material. The lots are referenced as Lots A and B in the package insert to note this difference.

Does the milky composition of the CRP R2 reagent have any impact on instrument dispense components?

No impact was observed over several years of internal product evaluation.

Did the CRP assay cause any build-up in the high-concentration waste pump manifold tubing?


If a reagent kit was not mixed properly before use then discovered after the fact, would it be acceptable to mix and run controls to determine whether to continue use? The amount of volume used for testing prior to mixing would have some impact on the suitability for use, but is it correct that we have only control performance to use in evaluating that?

It would be acceptable to continue if only a small quantity of reagent was used. You would not want the ratio of liquid reagent and concentration of the microparticles to change in the R2 cartridge. The cartridge should be mixed by gentle inversion, then evaluate controls.


Question Answer




As the lamp ages and performance diminishes, should we assume that results will increase for this assay? Logically, less lamp intensity would translate as additional turbidity, and therefore higher concentration. Were any study data generated with a diminished lamp?

A specific study has not been performed to evaluate diminished lamp intensity.


Question Answer




Creatine KinaseFlexRate™ linearity is not stated in the Linearity section of the CK package insert; however, Flex Read times (22 – 25) and Abs Limits (0 – 2.8) are configured in the assay parameters.

The Flex Read Time is used if less than three data points fall within the absorbance range during the Main Read Time. However, because of the nature of the CK assay, this condition does not occur, and the Flex Read Time is never utilized by the AEROSET System for the CK assay. Linearity of CK is 4,267 U/L. To obtain a higher value than 4, 267, the result can be auto diluted 1:2 or 1:10 using the dilution protocols defined for the CK assay.

Digoxin (MULTIGENT®)

Spironolactone/Canrenone Interference Results

A case report by Steimer et al has shown that a negative bias in the determination of digoxin results may be observed when the aldosterone inhibitor spironolactone or canrenone is present in serum. A sample containing 2.0 ng/mL of digoxin was spiked separately with 800 µg/L spironolactone and 3,000 µg/L canrenone and analyzed with the MULTIGENT Digoxin assay. The following results demonstrate no significant interference.

Reference: Steimer W, Muller C, Eber B, et al. Intoxication due to negative canrenone interference in digoxin drug monitoring. Lancet 1999;354:1176–7.

SampleControl

Concentration Recovered

Compound (ng/mL Digoxin)

(nmol/L Digoxin)

(ng/mL Digoxin)

(nmol/L Digoxin)

Spironolactone 1.98 2.53 1.98 2.53

Canrenone 2.07 2.65 2.12 2.71




Cross Reactivity

The following digoxin cross reactivity data are not included in the package insert.

NOTE: Test results were obtained with an alternate assay configuration with the same antibody as MULTIGENT® Digoxin.

Compound

Conc. of Cross Reactant Spiked

(ng/mL)

Digoxin Reported

Value (ng/mL)

% Cross Reactivity

Acetaminophen 1,000,000 0.0 0.0%

Cortisol(hydrocortisone)

10,000 0.0 0.0%

Cortisone 10,000 0.0 0.0%

Dehydroisoandrosterone 10,000 0.0 0.0%

D(+)-Digitoxose 10,000 0.0 0.0%

Estriol 10,000 0.0 0.0%

Furosemide 50,000 0.0 0.0%

Gitoxin 150 0.7 0.5%

Hydrochlorothiazide 100,000 0.0 0.0%

11α-Hydroxyprogesterone 10,000 0.1 0.001%

17α-Hydroxyprogesterone 10,000 0.0 0.0%

Lidocaine HCl 100,000 0.0 0.0%

Ouabain octahydrate 150 2.8 1.9%

Phenytoin 100,000 0.0 0.0%

Prednisolone 10,000 0.0 0.0%

Prednisone 10,000 0.0 0.0%

Procainamide 100,000 0.0 0.0%

Progesterone 10,000 0.0 0.0%

Propanolol HCl 100,000 0.0 0.0%

Quinidine sulfate dihydrate

100,000 0.0 0.0%

Salicylate 1,000,000 0.0 0.0%

Secobarbital 100,000 0.0 0.0%

Testosterone 5,000 0.0 0.0%




Sample Carryover

No sample carryover effects were observed when testing samples with high digoxin concentration (4.0 to 5.0 ng/mL) immediately before samples with low digoxin concentration (0.3 to 0.8 ng/mL).


Question Response

MULTIGENT® Digoxin results do not match another method. Why?

MULTIGENT Digoxin is a competitive binding method, in which lowest levels of digoxin concentration produce highest signal levels. In addition, the reading wavelength of 700 nm minimizes interference from HAMA (human anti-mouse antibodies), hemolysis, bilirubin, and lipemia. The disagreement between methods may be due to cross reactivity and interference differences.

Which controls are recommended? Which controls have AEROSET assay values?

Bio-Rad Liquichek TDM control has been used successfully with this method, although system-specific assay values are not provided in the package insert. Onboard stability and 20 day precision testing were done with this product.

Why am I getting negative calibration rates? Is this normal?

This is normal. The competitive binding method provides a curve in which the signal is inversely proportional to concentration, i.e., low sample values produce the highest rates. The zero calibrator rate (highest rate) is used as a blank and is subtracted from the rates of all other calibrators, causing them to be negative.

How does this assay perform with DLIS (digoxin-like immunoreactive substances)?

Refer to the Interfering Substances section of the Digoxin package insert.




Direct LDL (MULTIGENT®)

Sample Storage and Stability

• Samples should not be frozen at -20°C.

• Samples stored at -25°C for 1 month showed a – 14% bias.

• Samples stored at -80°C for 3 months showed a 2% bias.

Reagent Storage and Stability

• Do not freeze reagents.

• Protect reagents from light.

Calibrator Storage and Stability

• Do not refreeze calibrator.

• The calibrator should not be frozen at -20°C.

• The calibrator concentration changes with each lot number and is listed on the label.

• The calibrator is reconstituted with 1 mL DI water, allowed to stand for 5 minutes, and swirled until dissolved. Due to the low volume of the calibrator (1 mL), a 1 mL Class A volumetric pipette should be used.

• Do not shake the calibrator. Shaking can cause calibration inconsistencies due to bubbles in the vial.

• The calibrator is traceable to the National Reference System for Cholesterol, NRS/CHOL.

• The calibrator is supplied with the reagent, and cannot be ordered separately.




Linearity Verifiers (80-5953-00, 2 x 3 mL)

The Linearity Verifiers are Genzyme products and should be ordered from Genzyme. Verifiers are stable for 7 days when stored at 2 to 8°C.

Perform the following steps to confirm linearity of the assay.

1. Reconstitute with 3 mL of DI water, swirl, and let stand for 30 to 60 minutes at room temperature. Invert gently and let stand for an additional 15 minutes.

2. Make admixtures* from the high and low level verifiers, and run in quadruplicate.

* Admixtures are additional levels created by diluting the high and low level verifiers. Refer to the following table.

3. Graph the admixtures using 40% as the theoretical value. The 40% dilution is considered truth to calculate the remaining admixture’s theoretical values.

a. Calculate the mean value of the replicates for each dilution.

b. Calculate the theoretical value of each sample using the value determined for the 40% sample.

c. Plot the results: theoretical (x axis), mean values of the samples (y axis).

d. Inspect the plot for linearity and make a visual determination as to the acceptable reportable range.

e. Calculate the %recovery for each sample: %recovery = (mean result/theoretical result) × 100.

f. Each sample value should be within ± 10% of the theoretical value. If not, evaluate the clinical significance.

% Sample Volume High Verifier (µL)

Volume Low Verifier (µL)

0 0 500

20 100 400

40 200 300

60 300 200

80 400 100

100 500 0




g. Document findings.

% Sample Mean Result

Theoretical Result %Recovery

0 0.5 0 N/A

20 175 174 (= 40% Mean Result × 0.5)

101%

40 347 347 100%

60 80 694 (= 40% Mean Result × 1.5)

102%

80 704 694 (= 40% Mean Result × 2.0)

101%

100 886 868 (= 40% Mean Result × 2.5)

102%

The reportable range has been verified up to 868 mg/dL.




Observed Problem


Question/Comment Response

MULTIGENT® Direct LDL does not match the Friedewald (calculated) LDL.

• As the triglyceride level rises above 400 mg/dL, the Friedewald calculation underestimates the true LDL concentration.

• In the Friedewald, an erroneously calculated LDL result can be compounded by an error measuring total cholesterol, triglyceride, or HDL.

On a proficiency survey, the peer comparison looks OK—but the comparison to the reference method (ultracentrifugation) has a significant bias.

• Matrix effects are not uncommon with proficiency material, especially lipids.

• Results should be evaluated against the peer group for LDL.

• Comparison of the homogeneous LDL to ultracentrifugation should be performed using fresh serum samples.

The doctor is questioning the LDL result (high or low).

• Was the test repeated on the original serum or plasma sample?

• Are other lipid results available? Is the triglyceride level greater than 1,293 mg/dL?

• Sample integrity—verify the serum/plasma sample was stored at 2 to 8°C if not analyzed immediately.

• Was plasma used? Plasma in citrate tubes is not acceptable; use plasma in EDTA, sodium, or lithium heparin tubes.

A bias (negative or positive) is seen with CAP proficiency survey results.

Verify the customer is reporting under CAP Code 225: Liquid Selective Detergent.

Imprecision


Problem with sample probe (e.g., not aligned, bent, etc.).

1. Run multiple reps of sample to confirm the problem exists.

2. If problem still exists, troubleshoot the sample probe. Refer to Section 10, Troubleshooting and Diagnostics of the AEROSET System Operations Manual.




Ethanol

Specificity

Ethanol (ethyl alcohol) specificity was tested by conducting studies on specific compounds; refer to the package insert for additional information. An ethanol-free aqueous matrix was used. Levels tested exceeded toxic concentrations. Therefore, cross reactivity is not considered clinically significant, with the exception of n-propanol which showed a cross reactivity of approximately 10% in the Ethanol assay.

GGT

Observed Problem

Imprecision


R2 reagent probe is not centered over the cuvette. If R2 reagent is dispensed down the side of the cuvette, complete reagent/sample mixing does not occur.

Adjust the R2 reagent arm over the cuvette. Refer to Reagent Arm Adjustment in the Hardware section of this guide.




Haptoglobin

Observed Problem


















Hemoglobin A1c (MULTIGENT®)

Reaction Diagram

Step 1

Step 2

Hemoglobin A1c concentration is inversely proportional to absorbance change. High absorbance change = low HbA1c concentration; low absorbance change = high HbA1c concentration.

HbA1c (Sample) Anti-HbA1c

Antibody:Microparticle Complex (Reagent 1)

HbA1c:Antibody:Microparticle Complex (lower rate of agglutination—increased

absorbance rate)

Remaining Unbound Anti-HbA1c

Antibody:Microparticle Complex (Reagent 1)

HbA1c Hapten (Reagent 2)

HbA1c:Antibody:Microparticle Complex (higher rate of agglutination—decreased

absorbance rate)




Pretreatment (Hemolysate Preparation)

1. Using a calibrated positive displacement micropipette, dispense 400 µL Hemoglobin Denaturant into a microcentrifuge tube.

NOTE: Dispense Hemoglobin Denaturant directly to the bottom of the tube; do not allow the denaturant to drip down the inside of the tube.

2. Using another calibrated positive displacement micropipette, withdraw exactly 10 µL of the well-mixed whole blood patient specimen or control.

3. Insert the pipette into the microcentrifuge tube containing the Hemoglobin Denaturant, allowing the tip of the pipette to barely make contact with the surface of the denaturant. Dispense the specimen (1:41 dilution).

4. Withdraw and redispense the mixture two times, keeping the tip of the pipette in constant contact with fluid in the tube.

5. Mix by gently vortexing at medium speed 5 to 10 seconds. Avoid foaming.

6. Prior to testing, allow the hemolysate to incubate for at least 5 minutes at 15 to 30°C.

7. Transfer hemolysate to a sample cup and place on the instrument.




Accuracy by Recovery of Standards

Six midpoint samples were prepared by mixing 1:1 proportions of each calibrator with the next highest calibrator. In the following table, the shaded “theoretical” values are normal calibrator concentrations. The other values were prepared from these standards to yield the midpoint standards. An additional standard was created to test the very low end of the curve. Each midpoint sample was tested in triplicate; results are listed below.

The spline method of calibration matches the theoretical calculation value at the midpoints of the curve.

Theoretical g/dL

Recovered g/dL

Variation%

Variation g/dL

0.00 0.00 0 0

0.094 0.12 27.7 0.026

0.24 0.26 8.3 0.02

0.47 0.48 2.1 0.01

0.63 0.65 3.2 0.02

0.78 0.79 1.3 0.01

0.89 0.89 0 0

0.99 1.00 1.0 0.01

1.27 1.23 3.1 -0.04

1.54 1.57 1.9 0.03

1.80 1.85 2.8 0.05

2.06 2.06 0 0




Hemoglobin Denaturant Storage Conditions

The recommended storage temperature for the Hemoglobin Denaturant is 2 to 8°C. A study was performed to evaluate the effect of room temperature storage of Hemoglobin Denaturant. The study used the same lot of Hemoglobin Denaturant, with one bottle stored at 4°C and another stored at room temperature (22°C). One normal and one high sample were used for the evaluation. Results are listed in the following table.

There is little to no apparent difference between the HbA1c result for the room temperature (22°C) and 4°C denaturant solutions.

Sample Mixing (Vortex Mixing vs. Pipet Mixing)

A study was performed to evaluate effects of vortex mixing and pipet mixing on sample results. Procedures to perform this study are included below.

Vortex Mix

1. 400 µL denaturant was added to plastic tubes, using the same tip for three tubes.

2. Blood sample was pipetted by rinsing the tip once with blood.

3. The pipet tip was wiped clean on the outside, with precautions taken to not wick any sample.

4. Blood was dispensed into denaturant and the tip was rinsed two times.

5. The treated sample was vortexed at medium speed approximately five seconds.

Room Temp 2 to 8°C

HbA1c g/dL

THb g/dL

HbA1c %

HbA1c g/dL

THb g/dL

HbA1c %

Level 1, Rep 1 0.75 15.2 4.9 0.73 14.1 5.2

Level 1, Rep 2 0.75 15.3 4.9 0.73 14.7 5.0

Level 2, Rep 1 1.62 14.1 10.7 1.52 13.8 11.0

Level 2, Rep 2 1.61 14.9 10.8 1.50 13.9 10.8




Pipet Mix

1. 400 µL denaturant was added to plastic tubes.

2. Blood sample was pipetted by rinsing the tip once with blood.

3. The pipet tip was wiped clean on the outside, with precautions taken to not wick any sample.

4. Blood was dispensed into denaturant and the tip was rinsed two times.

5. The pipet tip used to dispense denaturant was used to mix the treated sample by pipetting and dispensing the sample five times.

The following data were observed.

There is no difference in the final HbA1c result based on mixing method.

Vortex Mix Pipet Mix

Prep 1, Rep 1 8.4 8.2

Prep 1, Rep 2 8.3 8.2

Prep 2, Rep 1 8.6 8.3

Prep 2, Rep 2 8.4 8.2

Prep 3, Rep 1 8.2 8.3

Prep 3, Rep 2 8.4 8.4

Mean 8.4 8.3





Any condition that shortens RBC survival, e.g., hemolytic anemia or hemolytic diseases, pregnancy, and recent significant blood loss, results in decreased HbA1c.

Samples containing hemoglobin variants S and C may result in up to a 40% increase in apparent HbA1c result.

Samples containing > 10% HbF may give lower results.

Samples containing HbE were shown to not interfere.

The following table was obtained from the National Glycohemoglobin Standardization Program (NGSP) website; it lists effects of frequently encountered hemoglobin variants and derivatives on HbA1c (GHB) measurement. A list of references can be found on the website, http://web.missouri.edu/~diabetes/ngsp.html. All of these methods, with the exception of Beckman Diatrac and Helena Glyco-Tek, were NGSP certified as of March 2002.

Method

Interference (Yes/No)

HbC Trait

HbSTrait

HbE Trait

Elevated HbF

Carbamyl-Hb

Axis-Shield Nycocard (Primus Nycocard)

No No — — —

Bayer DCA 2000 No No No — No

Beckman Diatrac Yes Yes — Yes Yes

Beckman Synchron CX7 No No — — —

Bio-Rad Variant A1c No Yes No — Yes

Bio-Rad Variant GHb No No — — —

Bio-Rad Variant II A1c

No Yes/No Conflicting

data in literature

— No � 24%

HbF

No

Helena Glyco-Tek Yes No — — —

Menarini HA8140

No Yes Yes No Yes/No Conflicting

data in literature

Primus CLC 330/385 No No No — No




Provalis Glycosal (Bio-Rad MicroMat)

Yes No — — —

Roche Cobas Integra Yes Yes — — —

Roche Tina-quant IINo No No No

� 30% HbF

No

Roche Unimate Yes Yes — — No

Tosoh A1c 2.2 Plus

No No Yes — Yes/No Conflicting

data in literature

Method

Interference (Yes/No)

HbC Trait

HbSTrait

HbE Trait

Elevated HbF

Carbamyl-Hb





Question Response

MULTIGENT® Hemoglobin A1c results do not match another method. Why?

MULTIGENT Hemoglobin A1c is an indirect method, in which lower HbA1c concentrations produce higher signal levels. This may provide less imprecision at these lower concentrations. The reading wavelength of 604 nm minimizes interference from HAMA (human anti-mouse antibodies), hemolysis, bilirubin, and lipemia.


MULTIGENT Hemoglobin A1c controls, LN 2K96-10, are recommended for the Hemoglobin A1c assay. Refer to the MULTIGENT Hemoglobin A1c Control value sheet for control ranges.


This is normal. The indirect assay method provides a curve in which the signal is inversely proportional to concentration, i.e., low sample values produce the highest rates. The zero calibrator rate (highest rate) is used as a blank and is subtracted from the rates of all the other calibrators, causing them to be negative.

How does this assay perform with specific hemoglobin variants, e.g., HbA2, HbF, HbS?

Refer to the Interfering Substances section of the Hemoglobin A1c package insert.

The Reaction Mode for Total Hemoglobin is listed as END UP in the package insert. Why does the Reaction Graph appear to show an END DOWN reaction?

• This occurs because sample and reagent are added and mixed at Read Time 1. However, it takes time for the reaction mixture to settle. Bubbles and swirling of the mixture in the cuvette cause absorbance of the sample to start at a higher number than when the final read is taken.

• The reaction is classified as END UP because absorbance increases with increasing analyte concentration within the main read window.




The Reaction Mode for HbA1c is listed as RATE UP in the package insert. Why does the Reaction Graph appear to show an END DOWN reaction?

• The reaction is defined as RATE UP because the change in absorbance per minute increases over time as agglutination occurs in the main read window.

• The appearance of the Reaction Graph is because the assay is based on competitive inhibition. When there is a small amount of HbA1c in the sample, the HbA1c hapten (agglutinator) in the R2 reagent binds with the HbA1c antibody-coated microparticles in the R1 reagent. The resultant agglutination causes increased absorbance.

• When HbA1c concentration in the sample is high, there is less agglutination because there are fewer binding sites available for the agglutinator. This results in a lower absorbance change over time.

Does Abbott have microcentrifuge tubes? Abbott TDx® centrifuge tubes, LN 9527-40 can be ordered. There are 100 tubes per box.

There is no sample probe SmartWash™ in assay configuration. Was hemolysate build-up on the sample probe an issue during assay testing?

Studies were run on assays most sensitive to hemolysis, and there was no evidence of hemoglobin interference. Also, calculations were done based on maximum sample probe carryover and the worst case of carryover was lower than hemoglobin interference claims for the assays most sensitive to it.

Why are four reagent cartridges provided for THb, and only two cartridges provided for HbA1c?

Reagent volume requirements are 200 µL for THb and 100 µL for HbA1c.

Besides MULTIGENT® HbA1c controls, have other vendor controls from been tested?

No.

Was sodium fluoride tested as an anticoagulant for the HbA1c assay?

No.


Question Response




ICT™

L and H (Reference Range) Result Flags Display with No Result when Error Log Message 351 or 352 Is Generated

When the Error Log Message “351 - ICT Reference Solution Cup Not Filling” or “352 - ICT Reference Solution Not Aspirated” is generated, the ICT result is masked but the L and H result flags display.

Resolution: There is no corrective action to mask the L and H flag. Refer to Error Log Messages—Supplemental Information in Section 10, Troubleshooting and Diagnostics of the AEROSET System Operations Manual for initial recovery from Error Log Messages 88, 351, and 352.




Immunoglobulin A

Observed Problems

Assay button text is black


Diluent not loaded and/or configured in assay parameters.

Configure correctly and/or load diluent.


















Immunoglobulin G

Observed Problems


















Immunoglobulin M

Observed Problems

Assay button text is black


Diluent not loaded and/or configured in assay parameters.

Configure correctly and/or load diluent.







Issues with the source lamp. Check the lamp:• Normal lamp function: flat line between

reads 2 and 16, and a smooth line bending from vertical to horizontal between reads 17 and 33.

• Lamp degeneration: progress curve not smooth (exhibits an erratic sawtooth appearance).















Iron


Desferal is the brand name for deferoxamine mesylate or desferoxamine; it is an iron chelating substance indicated for the treatment of acute iron intoxication and chronic iron overload. Desferal prevents iron from entering into further chemical reactions and readily chelates iron from ferritin and hemosiderin, but not readily from transferrin. It does not combine with iron from cytochromes and hemoglobin. Young states that Desferal (desferoxamine) chelates iron, making it unavailable to react with most chromagens thereby giving falsely low iron concentrations. Young also states, “At concentrations of 250 mg/dL and higher iron concentration reduced when measured by method on Kodak Ektachem systems”. In addition, the Vitros uses ascorbic acid as a reducing agent. Ascorbic acid is unique in its property not only to reduce but also chelate iron. Iron methodologies containing ascorbic acid are prone to over-recovery of serum iron liberated from non-transferrin sources. In one study, ascorbic acid significantly and selectively increased iron concentrations and iron recovery measured on the Ektachem.

Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed. Washington, DC: AACC Press, 1995:3-361–3-364.

Letter to Editor, Underestimation of serum iron with automated methods, Clin Chem 1995;41:1199–1201.

Physicians’ Desk Reference 54th Edition, Montvale, NJ, Medical Economics Company, 2000;54:2012–2013.

Kempinaire A, Laureys M, Goedhuys W, et al. Spuriously low concentrations of serum iron measured with Generation 14 Kodak Ektachem slides: prevalence, possible causes, and partial improvement with Generation 16 slides, Clin Chem 1992; 38:2457–64.




Magnesium

Units Conversion

Current assay configuration settings for the Magnesium assay provide mEq/L as conventional units and mmol/L as international (SI) units. If magnesium values will be reported in mg/dL units, edits to assay configuration parameters and Magnesium calibrator values are required. Editing the reporting units does not automatically convert the appropriate parameters.

In the Abbott Clinical Chemistry Iron/Magnesium calibrator package insert, calibrator values for the Magnesium assay are provided in mEq/L and mmol/L units. The calibrator vial lists Magnesium units in mEq/L only, due to limited area available on the vial label. Package inserts will be revised at a later date to include values for mg/dL; these values are listed in the following table.

When converting units for an assay, the following parameters must be edited, if applicable, using the appropriate conversion factor.

• Calibrator Values

• Panic Range

• Min and Max Values

• Reference Range

• Linear Range

• Qualitative Range

• Control Means

mEq/L mmol/L mg/dL

Magnesium Calibrator Value CAL 1

1.0 0.50 1.2


4.0 2.00 4.9




Perform the following steps to convert Magnesium results from mEq/L to mg/dL.

1. Multiply existing values by the conversion factor, 1.215.

2. Edit the following parameters as described in Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual. The following example uses values listed in the Abbott Clinical Chemistry Magnesium package insert, Commodity No. 30-3348/R6, March 2004.

3. On the Base page of the Assay Configuration screen, edit the Units field from mEq/L to mg/dL.

4. Edit control mean values on the CALIBRATOR/CONTROL screen.

5. Verify all edits are saved.

6. Calibrate the Magnesium and/or Magnesium Urine assays as appropriate.

7. Run two levels of controls to verify the calibration.

Parameters Requiring Edits Serum/Plasma Values in mg/dL

Urine Values in mg/dL

L-Reference 2.1 User defined value × 1.215, rounded to one significant digit

Reference-H 2.8 User defined value × 1.215, rounded to one significant digit

L-Linear Range 0.7 0.4

Panic-L User defined value × 1.215, rounded to one significant digit

User defined value × 1.215, rounded to one significant digit

Panic-H User defined value × 1.215, rounded to one significant digit

User defined value × 1.215, rounded to one significant digit

Linear Range-H 9.5 5.2


1.2 1.2


4.9 4.9




Methadone


Compounds listed in the following table yielded a negative result at 300 ng/mL methadone (Multi DOA Cutoff calibrator) when tested at the concentration listed.



l-Alpha-methadol 2

Buprenorphine 100

Caffeine 1,000

Cimetidine 1,000

Clomipramine 2.5

Clonidine 1,000

Cotinine 100

Cyclobenzaprine 28

Desipramine 800

Diphenhydramine 500

Doxepin 10


1,000

Fluoxetine 500

Glutethimide 500

Ibuprofen 1,000

Ketamine 100



Naproxen 1,000

Phenytoin 1,000

Ranitidine 900

Scopolamine 500

Tramadol 100

Tyramine 100


Zolpidem 100




Microalbumin (MULTIGENT®)

Specimen Storage

If specimens cannot be analyzed immediately, they should be stored observing the following guidelines:

• Up to two weeks at 4°C

• Up to five months at -70°C

• Repeated freeze/thaw cycles should be avoided

• Frozen specimens must be adequately mixed prior to testing; if not, reduced values could be observed


Question Response

Can I use another vendor’s controls, or is use of MULTIGENT Microalbumin controls required?

Bovine or other sourced control material, e.g., Bio-Rad controls, do not work with the MULTIGENT Microalbumin assay. The control must be a human-sourced control.Use MULTIGENT Microalbumin controls, LN 2K98-10.

If controls are out of range, what troubleshooting should be performed?

1. Check the dryer tip. If the dryer tip is not perfectly aligned, residual water or excess protein can remain in the cuvettes.

2. Inspect the sample probe for protein build-up.




Opiates 300


Compounds listed in the following table yielded a negative result at 300 ng/mL morphine (Opiates 300 calibrator) when tested at the concentration listed.


Acetaminophen 1,000




25


Amitriptyline 500

Buprenorphine 100

Caffeine 1,000

Cimetidine 1,000

Clomipramine 2.5

Clonidine 1,000

Cotinine 100

Cyclobenzaprine 28

Desipramine 800


Doxepin 10


1,000

Fluoxetine 500

Glutethimide 500

Ibuprofen 1,000

Ketamine 100



Naproxen 1,000

Nortriptyline 750




NOTE: Therapeutic doses of ofloxacin (Floxin) or levofloxacin (Levaquin), non-opiates, may produce positive results with this assay. A positive result from an individual taking ofloxacin or levofloxacin should be interpreted with caution and confirmed by another method.

Phenytoin 1,000

Promethazine 143

Ranitidine 900

Scopolamine 500

Thioridazine 100

Tramadol 100

Tyramine 100


Zolpidem 100





Opiates 2,000


Compounds listed in the following table below yielded a negative result at 2,000 ng/mL morphine (Multi DOA Cutoff calibrator) when tested at the concentration listed.


Acetaminophen 1,000




25


Amitriptyline 1,000

Buprenorphine 100

Caffeine 1,000

Cimetidine 1,000

Clomipramine 2.5

Clonidine 1,000

Cotinine 100

Cyclobenzaprine 28

Desipramine 800


Doxepin 10


1,000

Fluoxetine 500

Glutethimide 500

Ibuprofen 1,000

Ketamine 100



Naproxen 1,000

Nortriptyline 750




NOTE: Therapeutic doses of ofloxacin (Floxin) or levofloxacin (Levaquin), non-opiates, may produce positive results with this assay. A positive result from an individual taking ofloxacin or levofloxacin should be interpreted with caution and confirmed by another method.

Phenytoin 1,000

Promethazine 1,000

Ranitidine 900

Scopolamine 500

Thioridazine 100

Tramadol 100

Tyramine 100


Zolpidem 100





Phencyclidine


Compounds listed in the following table yielded a negative result at 25 ng/mL phencyclidine (Multi DOA Cutoff calibrator) when tested at the concentration listed.


Acetaminophen 1,000




Buprenorphine 100

Caffeine 1,000

Cimetidine 1,000

Clomipramine 2.5

Clonidine 1,000

Codeine 500

Cotinine 100

Cyclobenzaprine 28

Desipramine 800


Doxepin 10


1,000

Fluoxetine 500

Glutethimide 500

Ibuprofen 1,000



Naproxen 1,000

Nortriptyline 750

Phenytoin 1,000

Ranitidine 900

Scopolamine 500




Tramadol 100

Tyramine 100


Zolpidem 100





Prealbumin

Observed Problems







Issues with the source lamp. Check the lamp:• Normal lamp function: flat line between

reads 2 and 16, and a smooth line bending from vertical to horizontal between reads 17 and 33.

• Lamp degeneration: progress curve not smooth (exhibits an erratic sawtooth appearance).












Propoxyphene


Compounds listed in the following table yielded a negative result at 300 ng/mL propoxyphene (Multi DOA Cutoff calibrator) when tested at the concentration listed.


Acetaminophen 1,000




25


Buprenorphine 100

Cimetidine 1,000

Clomipramine 2.5

Clonidine 1,000

Cotinine 100


Doxepin 10

Fluoxetine 500

Glutethimide 500

Ibuprofen 1,000

Ketamine 100



Meperidine 1,000

Naproxen 1,000

Phenytoin 1,000

Ranitidine 900

Scopolamine 500

Thioridazine 100

Tramadol 100




Tyramine 100


Zolpidem 100





Rheumatoid FactorBefore troubleshooting the RF assay, ensure the assay parameters were configured correctly. Do not install the RF assay using assay parameters on the Import Disk—Serum Proteins Version 1.0.

NOTE: At the end of control shelf life, means may shift and control ranges may need to be reestablished. Bio-Rad Liquichek RF Control Level 1 varies in concentration.

Recommendation: Do not use Level 1 if < 15 IU/mL.

Standard Material Recovery

Recovery accuracy results of the standard material are summarized in the following table.

Assay Standard Material N Units Expected

ValueRecovered

(Mean) Value %Recovery

RF (LN 8G66)

WHO 64/2 4 mg/dL 3.92 3.8513 98.25

4 IU/mL 105.73 115.62 109.35

4 IU/mL 50.93 52.47 103.02

4 IU/mL 26.43 27.19 102.87





Question Response

How much shift is observed for the RF Bio-Rad Liquichek control toward the end of shelf life?

The Bio-Rad Liquichek Immunology control package insert states, “Variation over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents or by manufacturer test method modifications.”For the Abbott Clinical Chemistry RF assay application, we used control ranges of approximately 15%. In one case, the control ranges needed to be reset for controls near expiration. In one other case, controls possibly stored inappropriately required reevaluation after control ranges were established.Based on our experience, however, the need to reevaluate control ranges should be infrequent.

The RF R2 reagent contains latex microparticles. Is inversion of R2 reagent required before every run to ensure the particles do not settle?

Inversion is not required before running the test. The latex microparticles are very small and remain suspended after the R2 cartridge is initially inverted and placed on the Reagent Carousel.Although a specific study was not performed, we suspect the carousel movement keeps the microparticles suspended.

How much control variability should be observed between reagent lots of the RF assay?

The RF assay was tested with a minimum of three lots. These lots included freshly prepared reagent, and one nearing the expiration date. Minimal variability in controls was observed. Control ranges (also called Action Limits) were not reset with a change in reagent lot.




Were plasma specimens evaluated for use with the RF assay?

Yes. Initially, it was the project development team’s goal to develop a plasma claim for the RF assay application. Acceptable performance was observed with the majority of plasma specimens.However, there is a small population of plasma specimens that will generate a falsely elevated result. Therefore, it was not possible to generate a reliable plasma claim and customers should not use plasma specimens with the RF assay.

How would results be affected if reagent kits are inadvertently frozen during delivery? The package insert does not address this issue.

The customer should check QC performance. Freeze/thaw studies by the OEM supplier support acceptable performance with frozen material.

Will customers have an issue if there are not enough Abbott assay users when results from a proficiency survey are compared to other manufacturers’ RF assays?

CAP surveys do not work with RF and should not be used. The cause for this is under investigation. The RF assay cannot be used with plasma specimens, and CAP survey sample is based on plasma as well as other processing which makes it a very artificial matrix.

Were gel barrier tubes tested for use with the RF assay?

A study has not yet been performed with gel barrier tubes. However, this will be considered for a future study.


Question Response




During RF precision studies on the AEROSET and c 8000®, how many points were below the LOQ of 10, and excluded for the Level 1 control?

None. Excluding data points from the precision study would have prevented achieving the correct number of test results per the NCCLS protocol.Before performing any studies that involved a control (either for testing or assay validity check), a lot of Bio-Rad Liquichek Immunology controls requires setting Action Limits. If a specific control lot had a result for the Level 1 control that was too low, it was not assigned an Action Limit or used in subsequent studies. In those cases, only Level 2 and 3 materials were used.The frequency of obtaining a Level 1 control with a concentration too small is dependent on Bio-Rad manufacturing processes.

If RF is not inverted before use, what errors are observed?

A specific study has not been performed. However, if latex particles have settled to the bottom of the reagent cartridge and are not pipetted, it is possible that low absorbance values could be observed.

Is the Hitachi method for RF a turbidimetric method?

Boehringer Mannheim reagents for use on Hitachi instruments are described by the BM package inserts as “immunological agglutination” which is a turbidimetric method.

Is the assay number for the new RF assay the same as the original RF assay?

Yes. However, this it not an issue because the “original” RF assay was never released to customers.A new Import Disk—Serum Proteins Version 2.0 was released with the new RF assay.

Conv Units SI UnitsOld Import Disk LN 4E43-03 4E43-06New Import Disk LN 2K89-02 2K90-02


Question Response




Why does the RF assay have a Reaction Check programmed but the CRP assay does not?

The shape of the RF progress curve allows for use of the Reaction Check feature. At concentrations > 30 mg/dL, the CRP progress curve does not demonstrate enough difference in Read Times A & B for the Reaction Check flag to detect each occurrence. However, it was verified that the EXT and High flags work appropriately with CRP.

Why do AEROSET RF control means listed in the Precision section of the package insert not match those for c 8000®?

Precision studies for the AEROSET and c 8000 Systems were performed at different times with different lots of control material. The lots are referenced as Lots A and B in the package insert to note this difference.

Does the milky composition of the RF R2 reagent have any impact on instrument dispense components?


Did the RF assay cause any build-up in the high-concentration waste pump manifold tubing?


If a reagent kit was not mixed properly before use then discovered after the fact, would it be acceptable to mix and run controls to determine whether to continue use? The amount of volume used for testing prior to mixing would have some impact on the suitability for use, but is it correct that we have only control performance to use in evaluating that?

It would be acceptable to continue if only a small quantity of reagent was used. You would not want the ratio of liquid reagent and concentration of the microparticles to change in the R2 cartridge. The cartridge should be mixed by gentle inversion, then evaluate controls.

As the lamp ages and performance diminishes, should we assume that results will increase for this assay? Logically, less lamp intensity would translate as additional turbidity, and therefore higher concentration. Were any study data generated with a diminished lamp?

A specific study has not been performed to evaluate diminished lamp intensity.


Question Response




Total Bilirubin

Observed Problem

Total Protein


Dextran has been reported to negatively interfere with the Abbott Clinical Chemistry Total Protein assay, a biuret method.

The following summary is from the Methods in Clinical Chemistry, 1987, by Laurence A. Kaplan.

“Low molecular weight dextrans interfere with the biuret assay. The dextrans, used as plasma volume expanders for the treatment of low blood pressure, complex with copper and tartrate in the reaction mixture and form a precipitate. The degree of the resulting interference varies greatly with the concentration of dextran and the composition of the biuret reagent. The percent interference can range from 3% to 5% at usually encountered dextran levels. Although the interference is usually a positive one, a negative interference was reported for the bichromatic DuPont ACA procedure.”

Direct Bilirubin result exceeds Total Bilirubin result


Total bilirubin concentration of 0.2 mg/dL (3.4 µmol/L) or less; observed when nearly all reacting bilirubin is direct bilirubin.

For information only. In this situation, individual laboratories should establish reporting guidelines.

Hemolyzed sample. Obtain a new sample.




Transferrin

Observed Problems


















Valproic Acid (MULTIGENT®)

Accuracy by Recovery

Five midpoint samples were prepared by mixing 1:1 proportions of each calibrator with the next highest calibrator.

For example: 100 µL CAL 1 (0 µg/mL) + 100 µL CAL 2 (12.5 µg/mL) yields a 6.25 µg/mL standard.

Each midpoint sample was tested in triplicate and results are listed in the following table.


Any assay using mouse antibodies has potential for interference from human anti-mouse antibodies (HAMA) in the patient sample. To test this, we obtained a normal human serum pool (control) and two types of human anti-mouse antibodies, HAMA type 1 and HAMA type 2. We then spiked them with identical amounts of valproic acid. Each sample was assayed in duplicate on the AEROSET System using the MULTIGENT Valproic Acid assay. The means of both duplicate HAMA samples were compared to the mean of the control normal human serum. Test results show a recovery of 100 + 10%.

Expected Average Diff

Midpoint # (µg/mL) (µg/mL) %Recovery (µg/mL)

1 6.25 5.61 89.8 -0.64

2 18.75 19.10 101.9 0.35

3 37.50 37.60 100.3 0.10

4 75.00 78.41 104.5 3.41

5 125.00 122.52 98.0 -2.48

N Mean(µg/mL) %Recovery

Control 2 98.24 —

HAMA 1 2 90.96 92.6

HAMA 2 2 94.2 95.9





Question Response

MULTIGENT® Valproic Acid results do not match another method. Why?

MULTIGENT Valproic Acid is an indirect method, in which lower valproic acid concentrations produce higher signal levels. The reading wavelength of 604 nm minimizes interference from HAMA (human anti-mouse antibodies), hemolysis, bilirubin, and lipemia. The disagreement between methods may be due to cross reactivity and interference differences.


Bio-Rad Immunoassay Plus controls have been used successfully with this method, although system-specific assay values are not provided in the package insert.


This is normal. The competitive binding method provides a curve in which the signal is inversely proportional to concentration, i.e., low sample values produce the highest rates. The zero calibrator rate (highest rate) is used as a blank and is subtracted from the rates of all other calibrators, causing them to be negative.


Section 10: Software

System Troubleshooting Guide

Software


Software Not for Customer Distribution


NOTES


Not for Customer Distribution Software


Color Coding on the AEROSET System

Assay OK(Green)

Reagent Low/Cal error(Yellow)

Reagent expiredor empty/calibrationexpired orunusable

(Pink)

Illegal assay(Black)

Database Running(Brown)

Pending(Pink)

Complete/not validated

(Blue)

Incomplete/not validated

(Blue)

Validated(Black)

Run Progress Patient Sample(Gray)

STAT Sample(Pink)

Calibrator(Green)

Control(Yellow)

Water Bath Hot(Pink)

OK(Green)

Cold(Blue)

ControlsLevey-Jennings

Graph

2 SD(Yellow)

1 SD(Green)

3 SD(Red)

Outside 3 SD(Blue)

Cal SummaryPending/

Cal expired(Pink)

OK(Black)

Failed(Brown)

START UPSHUTDOWN

Bulk solutionslow

(Red)

Bulk solutionsOK

(Green)

Reagent Expired/empty(Pink)

OK(Green)

Reagent low(Brown)

Reagentscanned

(Brown text)

Reagentmanually

configured(Black text)

Assay Status Previous curve(grey)

Current curve(blue)

Stored curve(pink)

Error Log Level 1(Red)

No error(Gray)

Level 2(Pink)

Level 3(Yellow)

(Gray)(Blue) (Pink)




Exporting Files

Exported Data

A change was made to the name of the folder to which data are exported. In software v1.00ER005 and v1.00ER005.2, the folder was named USR. In software v1.02ER000, the folder is named EXTERNAL.

This change does not impact file names (which are user defined) and does not impact the export function.

Exported Files

Due to an anomaly associated with the Export function, when exported files are imported into a PC spreadsheet (.csv format), certain characters may not appear correctly on the spreadsheet. The following are some examples of this anomaly:

• French character é appears as “,”

• Spanish character ú appears as “£”

To correct the problem, manually edit the affected characters on the spreadsheet.




Host Interface Trace LogWhen transmission errors occur, the system generates an Error Log Message. The message in the Display Area no longer appears.

Use the following instructions to enable the Host Interface Trace log.

1. Log On with the “extra” or “guest” level user code and password.

2. Hold down the [Alt] key on the keyboard and press [Print Scrn]. The CONTROL BOX dialog window displays.

3. Select <Special> in the drop-down list box. The c:\ prompt appears in the Display Area.

4. Type dbgmode at the c:\ prompt then press [Enter].

5. In the drop-down list box next to Online, select <Printer>.

6. Select <OK>.

7. Type exit at the c:\ prompt to return to the Main Display.

When the Host communication error “Illegal Message: Text Error” is generated, ensure the Host is configured to resend the sample.

Use the following instructions to disable the Host Interface Trace log.


2. Hold down the [Alt] key on the keyboard and press [Print Scrn]. The CONTROL BOX dialog window displays.

3. Select <Special> in the drop-down list box. The c:\ prompt appears in the Display Area.

4. Type dbgmode at the c:\ prompt then press [Enter].

5. In the drop-down list box next to Online, select <NONE>.

6. Select <OK>.

7. Type exit at the c:\ prompt to return to the Main Display.




Observed Problems—Software=

Auto Rerun is not performed on replicate samples


System functionality. Manually order the rerun. Dil 1 or Dil 2 must be selected manually, if required.

CLT Result Error Code falsely generated for a diluted sample


The following sample aspiration sequence occurred:1. A sample that requires a dilution is

aspirated from the sample cup.2. A clotted sample is aspirated and a

CLT Result Error Code is generated.

3. The sample probe moves to the wash cup to attempt removal of clot.

4. The diluted sample cannot be dispensed into a new cuvette and is flagged with a CLT Result Error Code.

After the clot or clotted sample is removed from the system, rerun the diluted sample.

<START> is selected on the RUN OPTIONS screen to begin a run, but the run is not initiated; system status is READY


<START> was selected when the system status was changing from SUSPEND to READY.


2. Select <START> to initiate the run.




<START> is selected on the SELECT ASSAYS FOR STAT screen to begin a run, but the run is not initiated; system status is RUN


<START> was selected when the system status was changing from SUSPEND to READY.

1. Select <STAT> in the Action Area of the Main Display. The SELECT ASSAYS FOR STAT screen displays.

2. Select <START> to initiate the run.

Unresolved Host communications error, including but not limited to Error Log Message 339 Time Out, Order Not Received from SCC


Communication failure between the AEROSET system and Host interface.

Cycle power on both the AEROSET system and Host computer.




Quality Control

Interval QC

Interval QC is not based on the actual number of samples for an assay, but is based on the number of samples aspirated on the FastTrack™ or Sample Carousel. When the “As Needed” option is selected, QC will not run for an assay if samples were not run for that assay. When “As Needed” is not selected, the QC will run for every defined control at the set interval, whether or not samples are ordered for the assay.

Interval QC for all assays is reset by the instrument being powered off or when the interval occurs on a different day. In this example, the system was powered off as part of SHUTDOWN and the interval for the QC was reset.

QC Rounding

For a QC result to be flagged with an “L” or “H” Result Flag, the mean concentration and SD must be considered. A result is rounded to the reporting number of decimals for an assay after comparing the result to the QC range.

The range in the following example is 90 to 100.

When the result is 90, it is not known if the actual value was 90.001 (no Flag) or 89.999 (L Flag).

Actual Result Rounded Results Result Flag

90 90.0 L or No Flag

89.15 89.2 L

99.49 99.5 No Flag

99.89 99.9 No Flag

99.91 99.9 No Flag

99.95 100.0 No Flag

100 100.0 H or No Flag

100.34 100.3 H

100.45 100.5 H

100.56 100.6 H




QC Statistics—Decimal Places

The decimal places used for QC statistics are based on the value configured in the Decimal Places field on the Base page of the Assay Configuration screen.

Mean = Decimal places value + 1 additional decimal place

SD = Decimal places value + 1 additional decimal place

CV = 2 Decimal places (fixed)

Range = Decimal places value

Decimal Places Value (Base Page

of Assay Configuration

Screen)

Decimal Places of Mean Values

Decimal Places of SD Values

Decimal Places of CV Values

Decimal Places of Range Values

1 2 2 2 1

2 3 3 2 2

3 4 4 2 3




Rounding of NumbersThe AEROSET System allows only 7 digits, one of which may be a decimal. When the last digit is 5 or greater, the number rounds up. If the last digit is less than 5, the number rounds down. For example, 1.15 rounds to 1.2 and 1.14 rounds to 1.1.

Sample Sequence/Smart Sampling

Smart Sampling Selected Smart Sampling Deselected

Sample Sequence Defined

Only acknowledges ICT™ assays defined in Sample Sequence. Aspirates photometric assays using Smart Sampling scheduling. Iron* is always aspirated last.

Runs assays as defined in Sample Sequence, except Iron. Then runs assays in the order of buttons on the ASSAYS screen (left to right). Iron* is last, independent of button placement.

Sample Sequence Not Defined

Aspirates using Smart Sampling scheduling. ICT assays are run later in the run. Iron* is always aspirated last.

Aspirates in the order of buttons on the ASSAYS screen (left to right). Iron* is last, independent of button placement.

* Iron special handling is due to 2-cycle sample aspiration requirements.

• Sample Sequence—will run first defined A-Line assay with first defined B-Line assay, etc.• Does run a B-Line assay in cuvette pair where ICT assays are run as A-Line.




Screen Hierarchy

Act

ion

Are

a o

f th

e M

ain

Dis

pla

y

RU

N O

PT

ION

S

SE

LEC

T A

SS

AY

S F

OR

ST

AT

ST

AR

T U

P O

PT

ION

S

SH

UT

DO

WN

OP

TIO

NS

ER

RO

R L

OG

HO

ST

CO

MM

UN

ICA

TIO

N

Prin

ter

Con

figur

atio

n

Log

On

Sys

Cfg

Bee

p O

FF

Sm

plS

eq

Sam

plin

g

ON

LIN

E

CO

NF

IGU

RA

TIO

N

Res

etE

rr

Sys

tem

SC

C

Rgt

Are

a 2

Rgt

Are

a 1

QC

Rul

e

Rxn

Are

a

SW

Info

MA

INT

EN

AN

CE

U

TIL

ITIE

S

Prin

t

ST

OP

RE

AG

EN

T S

CA

N

RU

N O

PT

ION

SS

ysC

fgS

mpl

Seq

QC

Rul

e

Can

cel

Sav

e

Sta

rt




Info

rmat

ion

Acc

ess

Are

a o

f th

e M

ain

Dis

pla

y

Ord

erP

rint

AS

SA

YS

Del

Pre

v

RE

SU

LT

Prin

t Opt

ions

Pag

e S

etup

Ord

er S

ampl

es

LJ G

raph

Ass

ay S

tatu

s

Res

ult

CA

LIB

RA

TIO

N

SU

MM

AR

Y

QC

SU

MM

AR

Y

CA

LIB

RA

TO

R/

CO

NT

RO

L

Dat

esD

etai

lA

vera

ge

Con

figC

alib

Exp

ort

Dat

alis

tD

etai

ls

QC

Rep

lace

Cle

arW

izar

dE

xpor

tIm

port

Fre

eTex

t

ReC

alc

Edi

tR

erun

Rea

ctio

n G

raph

Acc

ept

Cal

ibra

tion

Bas

eO

utlin

e

Add

Del

ete

Leve

y-Je

nnin

gs

Gra

ph

Cal

Det

ails

Rer

un R

ules

Sm

artW

ash

QC

Err

or S

tatu

s

Set

2S

et 1

C/C

Crs

l

Abs

Dat

aE

xpor

t

Sav

eE

xpor

tIm

port

Prin

t

Set

3

Exp

ort

Dat

alis

tD

etai

ls

Del

ete

R1-

DR

1-C

R1-

BR

1-A

Vie

w

R2-

BR

2-A

R2-

CR

2-D

Cle

ar A

llR

epor

t

Opt

ions

For

m1/

2P

rint

Prin

tA

djus

ted/

Fre

e/N

orm

al

Prin

t

Sta

tus

Prin

t

Prin

t

Cle

ar A

llA

llS

tore

dP

rint

All

Exp

ort

Prin

t

D. R

ange

Del

ete

Del

ete

Rec

alc

Exp

ort

Rer

unR

xnG

raph

Acc

ept




Screen Navigation

Main Display

REAGENTS Screen




REAGENTS (Supply Center Segment) Screen

Reagent Supply Center Segment Details Screen

DILUENT

Bar Code Scanned (Reagent name text is BROWN)

Manually Configured (Reagent name text is BLACK)




DATABASE Screen

Search Dialog Window

Patient Demographics Dialog Window




Print Options Dialog Window—Order List/Loadlist

Order Samples Screen




PAGE SETUP Screen (Form 1)

Form 1 Report




PAGE SETUP Screen (Form 2)

Define Free Text Screen




Form 2 Report

On-line Data Transfer Dialog Window

5/21/98 13:10 Instrument #: 0001

Address 1Address 2Address 3Address 4Address 5

Sample ID: Age:Name: Nelson ,Harry Sex:Patient ID: Doctor:Carrier/Pos: 1(4) Date/Time Run: 5/21/98 11:32Comment:

ASSAY LOW/HIGH RESULT REFERENCE RANGES

Na-S L 135 mmol/L 136.0 - 145.0CO2 25 mEq/L 22.0 - 29.0Urea 12 mg/dL 7.0 - 18.0ALT 12 U/L 10.0 - 35.0Crea H 1.4 mg/dL 0.7 - 1.3Ca H 12.3 mg/dL 8.4 - 10.2Phos L 2.6 mg/dL 2.7 - 4.5TBil 0.8 mg/dL 0.2 - 1.0




RESULT Screen

RESULT Screen—Viewing Rerun Result




Reaction Graph Screen—Error Code

Reaction Graph Screen—Rate Assay




Reaction Graph Screen—End-point Assay

Absorbance Data Screen

DATABASE Screen, Accept Results Dialog Window




CALIBRATOR/CONTROL Screen

CALIBRATOR/CONTROL Screen—Set 1




Position Dialog Window

CALIBRATION SUMMARY Screen




Calibration Details Screen

QC SUMMARY Screen




Levey-Jennings Graph Screen

Print Options (QC) Dialog Window




Levey-Jennings Graph Report

QC Details Dialog Window

QC Data List Screen




ASSAYS Screen

ASSAY STATUS Screen




Assay Configuration Screen, Outline Page

Assay Configuration Screen, Base Page (End-point Assay)




Assay Configuration Screen, Base Page (Rate Assay)

Assay Configuration Screen, Calibration Page (Linear Calibration Mode)




Assay Configuration Screen, SmartWash™ Page

Assay Configuration Screen, Rerun Rules Page




RUN OPTIONS Screen

SYSTEM CONFIGURATION Screen

NOTE: The Sample Barcodes, Reagent Barcodes, External Robotics, and ICT™ fields can only be edited using guest Log On.




SELECT ASSAYS FOR STAT Screen

Pause Function




Unpause Function

START UP OPTIONS Screen




SHUTDOWN OPTIONS Screen

ERROR LOG Screen

Level 1 (Red)

Level 2 (Pink)

Level 3 (Yellow)




MAINTENANCE UTILITIES Screen, System Page

NOTE: Zero Set is only visible with guest Log On.

MAINTENANCE UTILITIES Screen, SCC Page




MAINTENANCE UTILITIES Screen, Sampling Page

NOTE: Step Edit is visible only with guest Log On.

Pressure Monitor Screen




MAINTENANCE UTILITIES Screen, Rgt Area 1 Page

MAINTENANCE UTILITIES Screen, Rgt Area 2 Page




MAINTENANCE UTILITIES Screen, Rxn Area Page

Cuvette Blank Screen




Cuvette Integrity Check Screen

MAINTENANCE UTILITIES Screen, SW Info Page

Printer A Configuration Window




ONLINE (HOST) CONFIGURATION Dialog Window

Run Progress Area

Log On Screen

User Alert Dialog Window

With Optional Clot Detection and Sample Carryover Reduction Installed

Without Optional Clot Detection and Sample Carryover Reduction Installed




System Configuration

FAC Limit % Field—Configuration

The FAC Limit % field was added to the Calibration page of the Assay Configuration screen with software version 1.02ER000. Acceptable entries in the FAC Limit % field range from 0 to 99. After installation of software v1.02ER000, the default setting is 10. If set to zero, the FAC Limit check is not performed.

For those assays configured on the AEROSET System at the time of software installation, the default setting for the FAC Limit % field is 10.

Any assays imported (from the Import Disks listed below) after upgrade to software v1.02ER000 will have a FAC Limit % default setting of 0 and must be edited to 10.

The FAC Limit % was defined as 10 (%) in all versions of AEROSET software prior to v1.02ER000, but this was not an editable field. This value was used in validation testing for all currently released Abbott assays and was applied to any non-Abbott assays configured on the system prior to v1.02ER000.

For non-Abbott assays or manually configured assays—the default setting will be 10 for the FAC Limit % field.

Refer to Assay Configuration in Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual for instructions on editing the FAC Limit % field.

• 4E43-02/4E43-05 Import Disk 1–50/Import Disk >50

• 4E43-08/4E43-09 Import Disk Drugs of Abuse v5.00

• 4E43-03/4E43-06 Import Disk Serum Proteins v3.0

• 4E43-04/4E43-07 Import Disk TDMs v4.00




System Configuration Software Disk v3.0

The AEROSET System Configuration Software Disk v3.0 can only be used with AEROSET software v1.00ER005.0 or v1.00ER005.2.

Do not use System Configuration Software Disk v3.0 with AEROSET software v1.02ER000 or greater. Installation of the System Configuration Software Disk v3.0 on a v1.02ER000 AEROSET System adversely affects system parameters on the Unit Configuration and automatic Startup/Shutdown Setting screens.

NOTE: AEROSET System software version 1.03ER000 prevents restoration of System Configuration parameters using a System Configuration disk created from a different version of system software.

The Unit Configuration and automatic Startup/Shutdown Setting screens should only be accessed by Abbott personnel. Perform the following steps to access these screens.


2. Perform the steps below to access the Unit Configuration or automatic Startup/Shutdown Setting screens.

a. Press [Alt] + [Print Screen] on the keyboard at the same time. The CONTROL BOX dialog window displays.

b. Press [�] on the keyboard to highlight the Special option then press [Enter] to select. A DOS window with the c:\prompt displays.

c. Type the appropriate entry to access the desired screen:

• Type unitconf then press [Enter] to access the Unit Configuration screen.

• Type setups then press [Enter] to access the automatic Startup/Shutdown Setting screen.

3. Edit the appropriate fields back to the default settings listed in the following sections. These screens should match exactly, except those fields noted as customer defined.

4. Select <OK> to save the settings and exit.




5. For the Unit Configuration screen only: select <OK> on the Save Parameters confirmation dialog window to return to the c:\ prompt.

6. Type exit then press [Enter].

7. Select the Exit icon in the Action Area of the Main Display to Log Off the system.

8. On the Log On screen, type bye in the User Code field.

9. Perform the Power OFF Procedure; wait 15 seconds then Power ON the system.




Unit Configuration Default Screen

The default view of the AEROSET software v1.02ER000 Unit Configuration screen is shown below. Also included is a table that describes fields on the Unit Configuration screen which can be affected if the System Configuration Software Disk v3.0 is loaded after upgrade to software v1.02ER000.

Figure 7: Unit Configuration Screen, Default View

Figure 8: Unit Configuration Default Screen, Default View Page 2 (Software Version 1.02ER000)

NOTE: For software v1.03ER000, refer to the following page for default settings on the Unit Configuration screen, Page 2.

1 24 3

5




* Customer defined at v1.02ER000 installation. Refer to the Installation Configuration Questionnaire included in the most recent revision of TSB 125-022.

** Not customer defined. These fields should not be changed from the default settings.

Unit Configuration Screen, Default View Page 2 (Software Version 1.03ER000)

Figure 9: Unit Configuration Default Screen, Default View Page 2 (Software Version 1.03ER000)

NOTE: The New Sample Wash Cup option should only be selected if the optional hardware upgrade was installed. Review the Log On screen to determine if this hardware was installed.

Unit Configuration Screen

Field Default Setting

1. Priority on Rgt Bar Code* Deselected

2. Multiple Rgt Ctgs* Deselected

3. Reagent Link* Deselected

4. Area/20mlW** 305

5. ICT™ reference cup check**

Selected




Startup/Shutdown Setting Default Screens

Default views of the AEROSET software v1.02ER000 automatic Startup/Shutdown Setting screen are shown below. Also included is a table that describes fields on the Startup/Shutdown Setting screen which can be affected if the System Configuration Software Disk v3.0 is loaded after upgrade to software v1.02ER000.

Figure 10: Startup/Shutdown (Startup-1) Settings Screen, Default View

* None of the Automatic START UP Options are customer defined. Each of these settings should match the defaults listed in this table.

Automatic START UP Options

Option Startup-1 Startup-2 Startup-3

Change Bath-water X X X

Wash Cuvettes X X X

Wash Probes by: Water Alk Water

• Water• Alk (Wash)• Acid (Wash)• Alk + Acid

Wash ISE by: ICAL EW + ICAL

• ICAL (IRef)• EW (I-Clean)• EW + ICAL

Change MCC(Drain & Fill IRef Cup)

X X

Probe Air Purge(Flush Water Lines)

X X X




Figure 11: Startup/Shutdown (Shutdown-1) Setting Screen, Default View

Automatic SHUTDOWN Options

Option Shutdown-1 Shutdown-2 Shutdown-3

Change Bath-water X X X

Wash Cuvettes X X X

Fill with Dtg

Wash Probes by:

• Water• Alk (Wash)• Acid (Wash)• Alk + Acid

Alk Water Alk

Wash ISE by:

• ICAL (IRef)• EW (I-Clean)• EW + ICAL

EW + ICAL

Change MCC(Drain & Fill IRef Cup)

X

Clear Database:• Cal, QC• All Results• All Records• Cal, QC, QC Clo• All Res., QC Clo• All Rec., QC Clo




User Codes/PasswordsA new user code/password was created to give customers access to “extra” level functions. The password changes daily, so the customer does not have permanent or ongoing access. The new user code is “guest” and the password is the same daily number used for IMx® and AxSYM®.

1 0507 21 0729

2 0128 22 0321

3 0908 23 1128

4 0816 24 0701

5 1006 25 0603

6 0222 26 0808

7 0524 27 0418

8 1026 28 0922

9 0130 29 1102

10 0817 30 0221

11 1107 31 0702

12 0513 32 0220

13 0616 33 1207

14 0202 34 0315

15 1016 35 0405

16 0728 36 1216

17 0614 37 0810

18 0416 38 1126

19 1119 39 0717

20 0924 40 0521




NOTES


Section 10: Hardware

Hardware


Hardware Not for Customer Distribution

222 AEROSET® System Troubleshooting Guide 94816-107—November 2004

NOTES


Not for Customer Distribution Hardware


CPU Used with the AEROSET SystemThe following table describes units used with the AEROSET System.

.

Figure 11: AEROSET CPU, Rear View (133/233 MHz)

CPU Memory (RAM)

ETM10-AD Pentium 133 MHz 16 MB

Pentium MMX 233 MHz 64 MB

Celeron 566 MHz 256 MB

KeyboardPort

Printer Port

125649

Host Port

PowerReceptacle

Monitor Port Touchscreen GPIBPort

Alignment Pin

Port




Figure 12: AEROSET CPU, Rear View (566 MHz)

Power Receptacle Printer Port

Monitor Port Touchscreen Port

GPIB Port

Keyboard Port Host Port




Cuvettes

Cuvette Volumes—Minimum and Maximum

Volumes (Min and Max) for the reaction cuvettes:

• Minimum volume in cuvette to achieve adequate mixing = 100 µL

• Minimum volume to achieve photometric reads = 160 µL

• Maximum volume of cuvette = 360 µL

Cuvette Warranty

The AEROSET cuvette warranty is one year post-installation.

Cuvette Identification

New cuvettes (type H) are shipped dry; however, cuvettes have been shipped dry since cuvette type G. That remains a valid way to identify “good” cuvettes, but type G cuvettes are also acceptable.

The only exact way to identify cuvettes is on the cuvette segment itself. The letter designation is located on the underside of the cuvette segment. In the following illustration, note the YC at the bottom. The C indicates this is a cuvette type C. There is no way to identify individual cuvette cells.

Figure 13: Cuvette Segment, Underside




GPIBGPIB is the acronym for General Purpose Interface Bus.

ICT™ Warranty InformationThe ICT module is warranted for whichever occurs first:

• A period of two months after installation on the AEROSET System, or

• 15,000 ICT samples, or• Until the expiration date on the package label.

Before troubleshooting the ICT module, verify it is within the stated usage period. The ICT module expiration date is on the label of the ICT module box. The expiration date can also be calculated by adding seven months to the date of manufacture coded in the ICT module lot number.

The customer should receive the ICT module a minimum of 90 days before the expiration date.

Noise SpecificationsWhen the instrument is running, continuous noise is 64 decibels (dB); non-continuous noise is 68 dB. For example, non-continuous noise is caused by an additional pump or degasser running that normally does not run the entire time a sample test is processing.

EXAMPLE: AA80717002

Month

Year

Day




Observed Problems—Hardware

Figure 14: Clot Detection Pressure Sensors

Erroneous Error Log Messages related to the Clot Detection system:341 Invalid Status Was Received from PM Board342 Sample Aspiration Error Occurred (A-Line)343 Sample Aspiration Error Occurred (B-Line)344 Unable to Remove Sample Probe Obstruction (A-Line)345 Unable to Remove Sample Probe Obstruction (B-Line)

NOTE: Refer to the following illustrations for details.


Sample probe is obstructed or damaged.

Clean or replace sample probe.

Sample arm tubing is crimped. Replace the sample arm tubing.

Pressure sensor tubing is loose or crimped.

Reseat or replace the pressure sensor tubing.

Pressure sensor is defective. Contact your Abbott Reprepresentative to replace the pressure sensor.




Figure 15: Clot Detection Pressure Sensors (Close-up)

Fatal Error: GPIB Error Log Message X (X equals 1 through 11)


• GPIB cable is loose or defective.• CPU printed circuit board is

defective.• Flash memory data are corrupt.• SCC previously configured in

Demo mode and software reloaded.

1. Reseat the GPIB cable.2. Reset error in the Error Log.3. Cycle power to the analyzer.4. Flash memory.5. Reconfigure SCC to Demo mode.

Cable to PCB

Tubing to Probe

Sensor

Tubing to Syringe




Reagent Supply Centers have no water


Water evaporated. Ensure Reagent Supply Center covers are securely in place.

Flush Water Lines option of the START UP Procedure was not performed.

Perform the Flush Water Lines option of the START UP Procedure.• Ensure water is present in the Reagent

Supply Center.• If still unresolved, contact your Abbott

Representative.

Cuvette wash pump valve failure or crimped tubing.

Contact your Abbott Representative.

System DI water source is not functioning.

1. Check the DI water system.2. Perform the Flush Water Lines option of the

START UP Procedure. Refer to Section 9, Service and Maintenance of the AEROSET System Operations Manual.

3. Check for water delivery to the Reagent Supply Centers.

Bellows pump failure/valve failure. Contact your Abbott Representative.

Refrigerator condensation pan contains bluish water


A bluish tint in the water originating from the Reagent Supply Centers’ refrigerated condensation units is caused by a coating within the unit. This observation is normal. The length of time of this situation varies, relative to the daily amount of condensation generated by the instrument. Under normal conditions, the bluish water should not persist longer than one month post-installation.

None required.




Serial NumbersInterpretation of AEROSET serial numbers:

A = AEROSET

3 = 2003, 2 = 2002, 1 = 2001, 0 = 2000, 9 = 1999, 8 = 1998, 7 = 1997

51 = January, 52 = February, 53 = March, 54 = April, 55 = May, 56 = June, 57 = July, 58 = August, 59 = September, 60 = October, 61 = November, 62 = December

2 = Space holder

001 = Sequence Number

For example A0542236 means AEROSET, April 2000, Sequence Number 236.




Specifications

Water

USP Purified and WFI Requirements

Purified Water Water for Injection

Conductivity Not greater than 2.1 mS/cm at 25°C*

Not greater than 2.1 mS/cm at 25°C*

pH 5.0 to 7.0 5.0 to 7.0

Total Organic Carbon Not greater than 500 ppb Not greater than 500 ppb

Total Bioburden Does not exceed 10,000 CFU/100 mL

Does not exceed 10,000 CFU/100 mL

Endotoxin N/A Not more than 0.25 Endotoxin Unit per mL

Coliform Level Zero per 100 mL Zero per 100 mL

* Refer to USP 24/NF19 Monograph <645> “Water Conductivity” if conductivity meter is not temperature compensated, or conductivity value exceeds 2.1 mS/cm at 25°C.

NOTE: The above USP specifications are derived from the ASTM Type III Specification.




Verification Procedures/Adjustments/Alignments

Lamp Gain and A/D Check

Perform the following procedure to check lamp gains and A/D reads. This will determine if the lamp should be replaced or if additional troubleshooting is necessary.

Materials Required

None

Procedure

1. Ensure the system status is READY.

2. Remove one cuvette segment.

3. Select the Maintenance Utilities icon in the Action Area of the Main Display. The MAINTENANCE UTILITIES screen displays.

4. Select the Rxn Area tab. The Rxn Area page displays.

Figure 16: MAINTENANCE UTILITIES Screen, Rxn Area Page

5. Using the Rxn Crsl buttons, rotate the Reaction Carousel to place the empty position in the optics light path.

6. Select Shutter <ON> to open the shutter.

Rxn Crsl

Shutter

Data




7. Select <Data>. The Photometer and ICT™ A/D Data screen displays.

Figure 17: Photometer and ICT A/D Data Screen

8. Observe the displayed Gain and A/D values. Ensure the Gain values are � 2.6 AND A/D readings are > 35,000, with a range of < 300.

NOTE: If the Gain value is 2.6 AND A/D reading is � 35,000, or if the Gain value is 4.0, replace the lamp. Refer to Source Lamp Replacement in Section 9, Service and Maintenance of the AEROSET System Operations Manual. After lamp replacement, recheck the Gain and A/D values; verify all Gain values are � 2.6 and A/D readings are > 35,000. If not resolved, contact your Abbott Representative.

9. Print the screen for reference. Select <OK>. The Rxn Area page of the MAINTENANCE UTILITIES screen displays.

10. Select Shutter <OFF> to close the shutter.

11. Using the Rxn Crsl buttons, rotate the Reaction Carousel to replace the cuvette segment.

12. Select Rxn Crsl <Home>.

13. Select <OK> to exit the Rxn Area page.

14. Select <Cancel>.

Gain and A/D Values




Reagent Arm Adjustment

NOTE: Ensure the reagent probe is not bent or damaged before performing any of the following adjustment procedures.

NOTE: The following procedures can be used for both the R1 and R2 probe reagent arm adjustment.

Materials Required

Empty reagent cartridge, large size

R1A Probe Horizontal Adjustment

NOTE: Any robotic position can be adjusted using the Adj (Adjust) button, clockwise or counterclockwise, after moving the robotic arm to that particular position.


2. Select the Rgt Area 1 tab. The Rgt Area 1 page displays.

3. Install a clean, empty reagent cartridge in position A1 of the Reagent Supply Center.

Figure 18: MAINTENANCE UTILITIES Screen, Rgt Area 1 Page

A-LIne (Outer)A <Adj>




4. Select A-Line (Outer) A <Adj> to position the empty cartridge in the R1A adjustment position.

5. Select Rgt Arm A Horz Rgt <Adj>.

CAUTION: The R1A reagent probe moves over the Reagent Carousel.

6. Verify the reagent probe is centered over the cartridge in position A1.

7.

8. Select <Adjust> on the right side of the screen.

If... Then

Reagent probe is not centered over the cartridge

Proceed to step 8.

Reagent probe is centered over the cartridge

Proceed to step 16.

!




9. Select <CW> (clockwise) or <CCW> (counterclockwise) as needed to center the probe over the reagent cartridge.

10. When the probe is centered, select <OK> to save the position.

11. Verify the probe position.

12. Select Rgt Arm A Vert Down <Adj>. Verify the probe is centered in the cartridge.

13. Select Rgt Arm A Vert Home/Up <Adj>.

NOTE: Proceed to step 14 if additional adjustment is needed.

14.

NOTE: If unable to center the probe front to back, proceed to Reagent Carousel Alignment.

15. When the probe is centered, select <OK> to save the position.

16. Select <OK> on the MAINTENANCE UTILITIES screen then select <OK> on the Home All Robotics dialog window.

If... Then

Reagent probe is not centered in the cartridge

Repeat steps 7 through 12.

Reagent probe is centered in the cartridge

Proceed to step 15.

CounterclockwiseClockwise




Reagent Carousel Alignment

NOTE: This procedure is performed after R1A Probe Horizontal Adjustment.

1. Install a clean, empty reagent cartridge in position A1 of the Reagent Supply Center.



4. Select Rgt Arm A Horz Rgt <Adj>.

5. Select A-Line (Outer) A <Adj>.


NOTE: Steps 1 through 5 position the empty cartridge in the R1A adjustment position.

A-Line (Outer)A <Adj>




6. Verify reagent probe alignment over the reagent cartridge.



9. Select <OK> to save the position.

10. Select Rgt Arm A Vert Down <Adj>.

11. Verify the reagent arm position.

12.


14. Repeat steps 4 through 12.

If... Then

Reagent probe is not aligned over the reagent cartridge

Proceed to step 13.

Reagent probe is aligned over the reagent cartridge

Select <OK> on the MAINTENANCE UTILITIES screen then select <OK> on the Home All Robotics dialog window.





R1A Probe Cuvette Alignment




3. Select Rgt Arm A Cuv <Adj>.

Rgt Arm ACuv <Adj>




4. Verify the R1A probe is centered over the A-Line cuvette in the Reaction Carousel.

5.


If... Then

R1A probe is not centered over the cuvette

Proceed to step 6.

R1A probe is centered over the cuvette

Proceed to step 9.

A-Line Cuvette





NOTE: If unable to align the reagent probes, contact your local Abbott Representative.



Clockwise

Counterclockwise




R1A Probe Wash Cup Alignment




3. Select Rgt Arm A WCup <Adj>.

NOTE: The reagent arm may not move if it is centered over the wash cup.

Rgt Arm AWCup <Adj>




4. Verify the R1A probe is centered over the wash cup.

5.


If... Then

R1A probe is not centered over the wash cup

Proceed to step 6.

R1A probe is centered over the wash cup

Proceed to step 9.




7. Select <CW> (clockwise) or <CCW> (counterclockwise) as needed to center the probe over the wash cup.


9. Select Rgt Arm A Vert Down <Adj>.

10. Verify the R1A probe is centered in the wash cup.

11.


13. Repeat steps 3 through 12.

NOTE: If the probe fails to align in the wash cup, contact your Abbott Representative.


If... Then

Reagent probe is not centered in the wash cup

Proceed to step 12.

Reagent probe is centered in the wash cup

Proceed to step 14.



Flowcharts

TroubleshootingFlowcharts


Flowcharts Not for Customer Distribution


NOTES


Not for Customer Distribution Flowcharts


Abbott Assay—Basic Assay Troubleshooting

Customerperceive assayis performingas expected?

Canperformance

change be tracedto a certain

event or date?

Yes

Text for assayon ASSAYS

screen green?Yes Stop

Investigate thefollowing

bullet points(next page)

Troubleshootevent, or

investigateimplementationof different lots/

shipments ofreagent or

calibrator fordate in question

Yes

No

NoNo

Yes

No

Proceed toQC OOR

FlowchartQC OOR?

Proceed toIllegal

Configuration orCalibration

ErrorsFlowchart




Abbott Assay—Basic Assay Troubleshooting, Continued

Assay Characteristics

If multiple assays are affected, look for similar characteristics such as:

• Same line

• Assays using R1 only vs. assays using R1 and R2

• Similar wavelengths

• Same calibrators

• Same sample and reagent volumes

• Rate vs. end-point reaction

If the issue affects one assay:

• Verify assay parameters with the assay-specific package insert

• Was a different bottle of reagent, calibrator, or control used, and was it handled correctly?

• Was a different lot of calibrator or reagent used?

• Are there any non-Abbott assays on the original line? If so, were carryover studies performed between those assays and the affected assay?

• Move the assay to an alternate line. If the issue is not resolved, proceed to step 2 of Instrument Troubleshooting.

Instrument Troubleshooting

1. Is the issue on both lines? If yes, troubleshoot common items, including:

• Lamp

• Cuvette washer

• Water

• Bulk solution use

• Maintenance

• Probe/mixer wash flow




2. If issue is only on one line, troubleshoot:

• Sample probes for damage, obstruction, and alignment

• Reagent probes for damage, obstruction, and alignment

• All probe tubing for crimps or leaks

• Sample, reagent, and wash solution syringes

• Mixers

• Maintenance

• Probe/mixer wash flow




Non-Abbott Assay—Basic Assay Troubleshooting

System ErrorLog Messages

NoOnly affected

assay?

What isconcern?

Illegal assayconfiguration:

noteassay-specific

error.Abbott Dist.

OEM reagents?

Followrecommended

troubleshooting inOperations

Manual

Yes

QC in range?

Canperformance

change betraced to a

certain eventor date?

Customertried freshreagent &

calibrators?

Open freshreagent &

calibrators;recalibrate.Resolved?

Yes

Was this aninstrumentevent? (e.g.,service call,

maintenance)

Abbott assayswith similar

characteristicsperforming as

expected?

Troubleshootevent

Investigateenvironment,operator, &

Refer toVendor

Yes

Instrumentmaintenanceup to date?

YesCarryover

studiesperformed?

Refer toVendor

Performcarryoverstudies

NoNo

No

Performmaintenance,recalibrate, &rerun controls

Yes

No

Yes

Refer toVendor

Yes

No

Patient issue?Sample

handlingcorrect?

No

Yes

Correct &repeat.

Resolved?

No

Stop

All calibratortargets entered

correctly?Yes

Calibrationconcern?

No No

Correctvalues &

recalibrate.Resolved?

No

No

Yes

Yes

Obtain fax ofcustomer

parameters.Verify assay

configurationparameters.

Correct?

Yes

Correctconfiguration& rerun assay

No

Obtain fax ofcustomer TPF &

vendorconfiguration.

Correct?

No

Yes

YesRefer toVendor

Yes

No

QC concern?

Recalibrate &rerun QC. OK?

QC prep &handling OK?

Preparefresh

controls &rerun QC.

OK?

AcceptData

Yes

YesNo

No

Yes

No

Yes

Yes

Yes

Start

Yes

Yes

Refer toVendor

Was event anew lot ofreagent orcalibrator?

No

Proceed toAbbott Assay—

Basic TSFlowchart

Proceed toIllegal

ConfigurationFlowchart

Proceed toAbbott Assay—

Basic TSFlowchart




Confirmation of Assay Parameter Settings (Illegal Configuration)

Check ifreagent ordiluent is

onboard. OK?

Reagent ordiluent

manuallyconfigured?

If black—assayparameter is

definedincorrectly

Select the assaybutton; select<STATUS> on

ASSAY STATUSscreen

Reagent oncorrect line?

No

Replace cartridge& touch newcartridge on

Reagent SupplyCenter SegmentDetails screen

Check individualAssay button &verify buttoncolor is black

Start

Load reagents thenperform reagent

scan or load diluent& configuremanually

No

Yes

Yes

Cartridgeempty or

low?

Move reagent tocorrect line &

rescan reagentsNo

Yes

Bar codelabel facingoutward?

Yes

Labeldamaged?

No

Readjustcartridges thenperform reagent

scan

YesManuallyconfigurereagent

No

Select tab onREAGENTS

screen matchingthe position;

reagent present?

No

Access Base pageon Assay

Configurationscreen; may needto pull in correct

position forreagent name/

position

Clear position& rescanreagents

Proceedto #2

(next page)Yes

Is Assay-specificError Message 10,11, or 12 visible?

Verify correctreagent & positionare on Base page

configuration. OK?

Yes

Bar codereader

windowclean?

Yes

No

Clean bar codereader windowthen performreagent scan

Yes

Yes




Confirmation of Assay Parameter Settings (Illegal Configuration), Continued

If everything is OK, and assay is still illegally configured (assay text still black), verify the following:

1. Assay name is in range 1 to 9999.

2. If a calibrator is defined, it must be placed in the specified position.

3. If a Use Factor calibration method is specified, the assay for the referred calibration curve must be configured.

4. If a diluent is defined, it must be placed in the specified position.

5. Sample Interference Indices—photometric assays to be run must be specified and configured.

6. Calculation Assays—all assays used for the calculation must be configured.

7. If a non-self (user defined assay file) blank is defined, the specified test must be configured.

8. Multiple Rgt Ctgs option is ON and R2 and/or R2 reagent is empty.

2




Erratic Results

Multipleassays?

Probesdripping?

Probescentered?

No

Yes

No

No

Edit assay

Recalibrate

Edit setpoints

Reagentexpired?

All maintenanceup to date?

Yes NoYes

QC & patientsamples?

Linespecific? No

Incubatordirty?

No

Patientonly?

NoQConly?

No

Probedamaged/

obstructed?

Replace poppetvalve. Dripping

resolved?

Check QChandling

No

Bubbles insyringes?

Yes

Assay configcorrect?

Calibrationcurrent?

Cal setpoints

correct?

Yes

YesNo

No

Yes

No

No

Quarterlymaintenance Yes

No

Non-Abbottassays?

No

SmartWashesconfigured?

Mixers OK?

Replace/styletprobe(s)

Yes

Yes

Carryoverstudy Yes

Replace mixers

Yes

No

No

No

Replace syringeseal tips &

O-rings.Drippingresolved?

Lamponboard

> 2 months?

ReplacelampYes

Drain & fillwater bath

Yes

Cuvettesegments

loose?Yes

Wash nozzlesdripping ormisaligned?

No

No

Yes

Cuvetteoverfill?

Dryer tipsdiscolored?

No

ConfigureSmartWashes™

Tighten

Styletnozzles

Yes

Replacetips

CuvetteIntegrity

pass?

Cuvetteoverfill?

HC wasteblocked?

Washcuvettes

manually

No

Yes

No

Replacereagent

Performmaintenance

Service

Yes

Yes

Yes

No

No

Yes

Yes

No

Yes

Yes

Yes

Performprecision runon selectedassays. OK?

Yes

No

No

Yes

No

Service

Stop

Replacepoppet

valves oralign

cuvettewasher

Yes

Precisionrun. OK?

Service

Stop

Yes

No

Precisionrun

Realignprobes

Replacetubing

Tubingkinked?

Check samplehandling

Precisionrun. OK?

Address any error codes. Refer to specific Troubleshooting in AEROSET System Operations Manual

Multiple reagent cartridgesin use with Rgt Link ON

(in SW v1.02ER000)?

Verfy emptycartridge is replaced

after changeover,before Reagent Scan

Yes

Yes

No




QC Out of Range

Multiple assays?

Verifycalibration.Check calvalues, cal

prep, &expiration. OK?

Verify system.OK?

Yes

Observed Problem:QC Out of Range

Recalibrate/reblank.

Rerun QC.OK?

Yes

QC prephandling OK?

Yes

Yes

Correct errors.OK?

Prepare freshreagent.

Rerun QC.OK?

No

Accept data

Yes

No

Verify properreagent

handling. OK?

Yes

Service

No

No

Prepare freshcontrols &rerun QC.

OK?

No

Yes

Recalibrate &rerun QC.

OK?

Yes

No

1.

2.

3.

4.

5.

No

No

No

No

Accept data

Yes

Yes




QC Out of Range, Continued1. Check for the following:

• Involved assays on same line?

• Involved assays using similar wavelengths?

• Is the reagent kit make up the same for all assays involved? R1 vs. R2?

2. Multiple assays? Check for the following:

• Test file parameters are correct

• Recent QC or reagent lot changes

• Recent shifts or trends in QC data

• Is QC material assayed or unassayed?

• Manufacturer claims for analyte stability

• Are ranges appropriate to assess system performance?

• Peer group statistics

3. Verify reagent handling:

• Prepared correctly, if preparation required

• Reagent loaded in correct Reagent Carousel and position

• Expiration date

• Date reagent was opened and placed onboard

• Pipettes—disposable or washed?

• Workload pattern

4. Check calibrators for the following:

• Correct values entered

• Dates opened

• Placed onboard in correct positions

• Length of time calibrators have been onboard

5. Verify instrument:

• Check when source lamp was installed

• Ensure all scheduled maintenance is current

• Check for damaged probes, drips, or drops

• Check cuvette washer performance

• Check for instrument leaks, e.g., pumps and syringes




• Check robotic training for sample and reagent arms, mixer, and ICT™ module

• Check for incubator temperature errors

• Ensure reagent carousels are cold and have puddles of water in compartments




Calibration Errors

Calibration errorgenerated? QC OOR?No Yes

ICT™calibration

failed?

No

Yes

No

Check calibratorconcentration,

carousel location,calibrator handling &expiration, & reagent

open & expirationdates. OK?

Yes

NoCorrect &recalibrate.

OK?

1. Did onlyone assay fail?

No

Verify assayconfiguration.

OK?

Correct &recalibrate.

OK?

Same calibratorsused for all

assays?

Verify assayconfiguration.

OK?

Start

Nocalibration

Open freshcalibrators &

recalibrate. OK?Yes

Yes

2. All assays onthe same line?

3. Move toopposite line &recalibrate. OK?

Yes

No

Yes

Yes

Proceed to #4(next page)

Proceed to #3

Review RunOptions

calibrationcheckbox. OK?

Correct &recalibrate.

OK?

Yes

NoYes

Yes

NoCorrect &recalibrate.

OK?

Yes

Verify caltargets on

CALIBRATOR/CONTROLscreen. OK?

No

No

Correct calibratortarget &

recalibrate. OK?

Cycle power &calibrate. OK?

Yes

No

Delete & reinstallassay & calibrate.

OK?

Service

No

Proceedto QCOOR

Flowchart

No

No

No

No

Proceed toICT FailedCalibrationFlowchart

Troubleshoot perOperations Manual.

Resolved?

No

Open freshreagent &recalibrate.

OK?

Open freshcalibrators &recalibrate.

OK?

No

Yes

Stop

No

Yes

Yes

StopNo

Yes

Yes

No

NoYes

Stop

Proceedto QCOOR

Flowchart

Proceedto QCOOR

Flowchart

Yes

Yes

Stop

Yes

Run QC.OK?

Run QC.OK?

Run QC.OK?


No

No

Run QC.OK?

Yes

Yes

Yes

Yes No

No




Calibration Errors, Continued

No

Yes

No

6. Replace lamp& recalibrate.

OK?

Service

5. Checkdispense

components. OK?No

Adjust, replace, or cleanaffected component(s)

& calibrate. OK?

Yes

Yes

Open new lot ofreagent &

recalibrate. OK?(If already done,proceed to #6.)

4. Open new lotof reagent &

recalibrate. OK?

Stop

Open new lot ofcalibrators &

recalibrate. OK?Yes

No

No

Yes

No

Is cuvette washerdripping or

overflowing cuvettes?Yes

Replace poppetvalve or look for

obstruction in HCwaste tubing.

Resolved?

No

No Service

Yes

Yes

No

Stop

No

Open new lot ofcalibrators &

recalibrate. OK?(If already done,proceed to #6.)

No

Yes

Yes

No

Yes

Proceedto QCOOR

Flowchart

Proceedto QCOOR

Flowchart

Proceedto QCOOR

Flowchart

Run QC.OK?

Run QC.OK?

Recalibrate.OK?

Run QC.OK?

Run QC.OK?

Yes

Yes

Yes

Run QC.OK?

Yes Stop

No

Proceedto QCOOR

Flowchart




ICT™ Failed Calibration

Review error codes &troubleshoot per Operations

Manual. Resolved?

Bubbles in ICTmodule tubing or

1 mL syringe?

No

Determine whether Serum and/or Urine ICT failed calibration

Verify ICT module lotnumber & installation

date

No

Yes

Replace ICTmodule

Yes

Yes

ICT module:1 Onboard > two months?2 More than 15,000 samples?3 Past expiration date?

Proceedto Bubbles

in ICTFlowchart

Error Log Message with1.02ER000 software

Error Log Message with1.02ER000 software

Remove bubbleswith applicator stick& recalibrate. OK?

Verify calibrator positions,target values, correct calsused, open & exp. dates.

All OK?

Bubbles in calibratorsample cup?

1 Verify ICT Dil lot number& onboard date.

2 Verify cartridge location.3 Verify reagent loadlist.OK?

Yes Stop

No

No Correct &recalibrate. OK?

Yes

YesNo

No

Stop

No

B No

Yes




ICT™ Failed Calibration, Continued

B

ICT diluent cartridgeempty or expired?

No

Replace ICTdiluent cartridge

Yes

Bubbles in IRefsolution bottle

tubing?Yes

IRef tubing not insolution?Twisted?

NoReposition/untwist

tubing into IRefsolution bottle

Replace IRef solutionfilter at end of tubing

(QuarterlyMaintenance)

IRef cup draining& filling

correctly?

Perform preheatertestNo

Yes

Inspect Sample Aprobe: Bent?Damaged?Build-up?

YesClean/replace

Sample A probe

No

Inspect R1Aprobe: Bent?Damaged?Build-up?

Service

Replace R1Aprobe

Yes

Verify IRef solution lotnumber & open date

Yes Replace IRefsolution bottle

IRef bulk solutionbottle empty or

expired?

No

No

No

Yes




Bubbles in ICT™ Module Tubing ICT reference solutionempty, or volume too

low for the filter toreach?

ICT reference solutiontubing all the way

down in the bottle?

Correct positioning thenperform the Wash ICT with

IRef and Drain & Fill IRef Cupof the START UP Procedure.

Bubbles gone?

ICT probe damaged,blocked, and/or

positionedincorrectly?

Seals present & seatedcorrectly in the ICTmodule at the top &

bottom?

If missing, replace seals. Verify seals areseated correctly; do not overtighten

connections. Perform the Wash ICT withIRef option of the START UP Procedure.

Bubbles gone?

Connections at theICT module loose ?

Connection at the1 mL aspiration

syringe or aspirationpump valve loose?

Reconnect and/or replace syringe ifneeded. Perform the Wash ICT with IRefand Drain & Fill IRef Cup options of theSTART UP Procedure. If the 1 mL syringe

is replaced, refer to the 1 mL SyringeReplacement Procedure in Section 9 of

the Operations Manual.Bubbles gone?

Other Possibilities:ICT aspiration tubing damagedICT aspiration pump defectiveIRef solution filter needs to bechangedPreheater check

Yes

Yes

Yes

Yes

No

Yes

No

No

YesStart Yes

No

Yes

Lift IRef bottle toverify functioning of

weight platform.Correct?

No

No

Yes

No

No

Yes Stop

Yes

Yes

No

No

Yes

Replace solution then performthe ICT Reference Solution

Loading Procedure in Section 9of Operations Manual.

Bubbles gone?

Access module &tighten top &

bottomconnections. Donot overtighten.

Perform the Wash ICTwith IRef and Drain & FillIRef Cup options of theSTART UP Procedure.

Bubbles gone?

Correct probe position. Referto the ICT Probe/ModuleReplacement Procedure in

Section 9, Operations Manual.Bubbles gone?

No

No

No

Service

Service




LIS/Communication ProblemsCycle power in this orderto establish handshake:Host down/AEROSET

down/Host up/AEROSETup

Yes

Error LogMessage?

Bar code facingcorrectly?

1.

2.

3.

Configurationchanges?

Bar code errors?

Yes

Yes

Check systemconfiguration. Bar

codes selected?

Powercycled?

YesCorrect sample

position

Bar codedamaged?

No

YesSelect bar

codes (guestlog on)

Cyclepower toAEROSET

No

Yes

Power?

Bar codeconfiguration

OK?

Make new barcode or runmanually

No

NoEdit Barcode

Length-Skip-IDfield

Cyclepower

Yes

No

Attemptrun.

Resolved?

Yes

YesNo

Yes

YesNo

No

Contact LISsupport Stop

Stop



No


No

No

Cyclepower

Power issuesor Error LogMessages?

Run.Resolved?

No

Attemptrun.

Resolved?

Run.Resolved?

Run.Resolved?

StopYes .

Troubleshoot perOperations

Manual. Resolved?

Yes

No

Yes




LIS/Communication Problems, Continued

4.Host icon

with green linethrough it (or not

BLUE)?

Host cableconnected?

Connectcable

Cyclepower

Verifyconfiguration

matches on Host &AEROSET

Changesrequired?

Make changes& cycle power

Run.Resolved?

Yes

Run debug

Change toAEROSET

configurationrequired?

YesCyclepower

No

No

Yes

Contact LISVendor

Evaluate debug;consult LIS

support

Yes5.

NoYes

No

No

Stop

Service

No YesRun.Resolved?

Run.Resolved?

No

Hostsuspended?

Yes

No

Yes"Resume" Hostcommuniction




Water Issue

Stop

Service

1 Plug in2 Turn on3 Use another outletLight on?

Check externalwater carboy;water present?

Yes

Error Log Messages99, 100, 240-248

Air in tubing?

Yes

Verify:1 Cap plugged

in?2 Switch on?3 Outlet has

power?

Yes

1 Check tubingconnections &crimps

2 Clean & replacefilter, if necessary

3 Cycle power toAnalyzer

4 Flush lines onSTART UP screen

Service

External waterprior tocarboy?

Yes

Air stillpresent?

Carboyoverflow?

Check inputpressure: 30 to 40psi desired. Adjust

if necessary

Pull up cap.Does water

flow?

Yes

Yes

NoCheck

external watersupply. OK?

Yes

Service

Proceed toB

No

Flush waterlines. Resolved?

No

Yes

No

Yes

No

No

Yes

Contactwater vendor

Can customerresolve?

No

No

Yes

No

1 Cycle power2 Perform flush

water linesResolved?

A

B

Yes

Yes

Stop

No

Documents

System Troubleshooting Guide - yeec.com · PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution AEROSET® System Troubleshooting Guide 3 94816-107—November