14
APTEC DIAGNOSTICS 19.02.2008 APPLICATION NOTE ADVIA 1200 AGP MONOREAGENT 2 ND GENERATION 1. Reagent preparation Sample: Ready for use Reagent (R1): Monoreagent, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point. 2. Analytical Parameters (Chemistry) TYPE # Analytical conditions Sub-analy. conditions R1 volume 250 Name AGP R2 volume 0 Digits * R3 volume 0 M-wave.L. 340 R4 volume 0 S-wave.L. 694 R1 diluent vol 0 Analy.Mthd EPA R2 diluent vol 0 Calc.Mthd MSTD R3 diluent vol 0 Qualit.judge Not do R4 diluent vol 0 Calculation method setting Serum reac.s.vol 10 M-DET.P.l 0 Serum dil.method SPECIAL M-DET.P.m 40 Serum dil.s.vol 10 M-DET.P.n 41 Serum dil.volume 90 S-DET.P.p 0 Serum dil.posit RTT position diluent S-DET.P.r. 0 Reaction time 10 min. Check D.P.I. 0 Reagent 1 stir Weak Limit value 0.003 Reagent 2 stir Weak Variance 10.0 Reagent 3 stir Weak * Prozone Reagent 4 stir Weak Prozone form NONE Prozone limit Reanalysis conditions Prozone judge Serum reac.smp.vol (u) 20 M-DET.P.m Serum dilut.method (u) STD M-DET.P.n Serum dil.smp.vol (u) 30 S-DET.P.p Serum diluent vol (u) 120 S-DET.P.p Serum diluent posi (u) 0 S-DET.r Serum reac.smp.vol (d) 5 * Endpoint Serum dilut.method (d) SPECIAL Re.absorb (u) 1.700 Serum dil.smp.vol (d) 5 Re.absorb (d) -1.450 Serum diluent vol (d) 95 Serum diluent posi (d) 0 Standard settings Multi-STD Formula LOGITLOG3 Axis conv. NO CONVERT Points 5 POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L BLK * 1 * ** Special 2 148 CTT position diluent 9.999 -9.999 2 * ** Special 3 117 CTT position diluent 9.999 -9.999 3 * ** Special 5 95 CTT position diluent 9.999 -9.999 4 * ** Special 10 90 CTT position diluent 9.999 -9.999 5 * Data entered by operator ** Concentration of standard 3. Order information 122A002 25 mL Monoreagent MPH/STH-001 Protein Standard High, 1 mL 139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL

APPLICATION NOTE ADVIA 1200 AGP MONOREAGENT · APPLICATION NOTE ADVIA 1200 AGP MONOREAGENT 2ND GENERATION 1. ... APPLICATION NOTE ADVIA 1200 ASL (250 – 50 KIT) 1. Reagent preparation

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APTEC DIAGNOSTICS 19.02.2008

APPLICATION NOTE ADVIA 1200

AGP MONOREAGENT 2

ND GENERATION

1. Reagent preparation Sample: Ready for use Reagent (R1): Monoreagent, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point.

2. Analytical Parameters (Chemistry) TYPE #

Analytical conditions Sub-analy. conditions

R1 volume 250 Name AGP

R2 volume 0 Digits *

R3 volume 0 M-wave.L. 340

R4 volume 0 S-wave.L. 694

R1 diluent vol 0 Analy.Mthd EPA

R2 diluent vol 0 Calc.Mthd MSTD

R3 diluent vol 0 Qualit.judge Not do

R4 diluent vol 0 Calculation method setting

Serum reac.s.vol 10 M-DET.P.l 0

Serum dil.method SPECIAL M-DET.P.m 40

Serum dil.s.vol 10 M-DET.P.n 41

Serum dil.volume 90 S-DET.P.p 0

Serum dil.posit RTT position diluent S-DET.P.r. 0

Reaction time 10 min. Check D.P.I. 0

Reagent 1 stir Weak Limit value 0.003

Reagent 2 stir Weak Variance 10.0

Reagent 3 stir Weak * Prozone

Reagent 4 stir Weak Prozone form NONE

Prozone limit

Reanalysis conditions Prozone judge

Serum reac.smp.vol (u) 20 M-DET.P.m

Serum dilut.method (u) STD M-DET.P.n

Serum dil.smp.vol (u) 30 S-DET.P.p

Serum diluent vol (u) 120 S-DET.P.p

Serum diluent posi (u) 0 S-DET.r

Serum reac.smp.vol (d) 5 * Endpoint

Serum dilut.method (d) SPECIAL Re.absorb (u) 1.700

Serum dil.smp.vol (d) 5 Re.absorb (d) -1.450

Serum diluent vol (d) 95

Serum diluent posi (d) 0

Standard settings Multi-STD

Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5

POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L

BLK *

1 * ** Special 2 148 CTT position diluent 9.999 -9.999

2 * ** Special 3 117 CTT position diluent 9.999 -9.999

3 * ** Special 5 95 CTT position diluent 9.999 -9.999

4 * ** Special 10 90 CTT position diluent 9.999 -9.999

5

* Data entered by operator ** Concentration of standard

3. Order information 122A002 25 mL Monoreagent MPH/STH-001 Protein Standard High, 1 mL

139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL

APTEC DIAGNOSTICS 19.02.2008

APPLICATION NOTE ADVIA 1200

ASL (250 – 50 KIT) 1. Reagent preparation Sample: Ready for use Reagent: Buffer, ready for use Start: Latex, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point.

2. Analytical Parameters (Chemistry) TYPE #

Analytical conditions Sub-analy. conditions

R1 volume 100 Name ASL

R2 volume 0 Digits *

R3 volume 20 M-wave.L. 594

R4 volume 0 S-wave.L.

R1 diluent vol 0 Analy.Mthd EPA

R2 diluent vol 0 Calc.Mthd MSTD

R3 diluent vol 0 Qualit.judge Not do

R4 diluent vol 0 Calculation method setting

Serum reac.s.vol 6 M-DET.P.l 0

Serum dil.method A dilution 40

Serum dil.s.vol 30 41

Serum dil.volume 120 17

Serum dil.posit RTT position diluent 18

Reaction time 10 min. Check D.P.I. 0

Reagent 1 stir Weak Limit value 0.003

Reagent 2 stir Weak Variance 10.0

Reagent 3 stir Weak * Prozone

Reagent 4 stir Weak Prozone form NONE

Prozone limit

Reanalysis conditions Prozone judge

Serum reac.smp.vol (u) 6 M-DET.P.m

Serum dilut.method (u) NONE M-DET.P.n

Serum dil.smp.vol (u) 0 S-DET.P.p

Serum diluent vol (u) 0 S-DET.P.p

Serum diluent posi (u) 0 S-DET.r

Serum reac.smp.vol (d) 2 * Endpoint

Serum dilut.method (d) STD Re.absorb (u) 1.700

Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450

Serum diluent vol (d) 120

Serum diluent posi (d) 0

Standard settings Multi-STD

Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5

POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L

BLK *

1 * ** Special 3 117 CTT position diluent 9.999 -9.999

2 * ** Special 5 95 CTT position diluent 9.999 -9.999

3 * ** Special 10 90 CTT position diluent 9.999 -9.999

4 * ** Standard 30 120 CTT position diluent 9.999 -9.999

5

* Data entered by operator ** Concentration of standard

3. Order information 129C004 1 x 10 mL Antiserum 2 x 25 mL Buffer ASL/STH-5X1 ASL Standard High, 1 mL ASL/CON-001 ASL Control, 1 mL

139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL

APTEC DIAGNOSTICS 11.01.2007

APPLICATION NOTE ADVIA 1200

C1 ESTERASE INHIBITOR N-DIL (AUS-KIT) 1. Reagent preparation Sample: Ready for use Reagent: Buffer, ready for use Start: Antiserum, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point.

2. Analytical Parameters (Chemistry) TYPE #

Analytical conditions Sub-analy. conditions

R1 volume 180 Name C1I

R2 volume 0 Digits *

R3 volume 20 M-wave.L. 340

R4 volume 0 S-wave.L.

R1 diluent vol 0 Analy.Mthd EPA

R2 diluent vol 0 Calc.Mthd MSTD

R3 diluent vol 0 Qualit.judge Not do

R4 diluent vol 0 Calculation method setting

Serum reac.s.vol 10 M-DET.P.l 0

Serum dil.method A dilution 40

Serum dil.s.vol 30 41

Serum dil.volume 120 17

Serum dil.posit RTT position diluent 18

Reaction time 10 min. Check D.P.I. 0

Reagent 1 stir Weak Limit value 0.003

Reagent 2 stir Weak Variance 10.0

Reagent 3 stir Weak * Prozone

Reagent 4 stir Weak Prozone form NONE

Prozone limit

Reanalysis conditions Prozone judge

Serum reac.smp.vol (u) 2 M-DET.P.m

Serum dilut.method (u) NONE M-DET.P.n

Serum dil.smp.vol (u) 0 S-DET.P.p

Serum diluent vol (u) 0 S-DET.P.p

Serum diluent posi (u) 0 S-DET.r

Serum reac.smp.vol (d) 5 * Endpoint

Serum dilut.method (d) STD Re.absorb (u) 1.700

Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450

Serum diluent vol (d) 120

Serum diluent posi (d) 0

Standard settings Multi-STD

Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5

POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L

BLK *

1 * ** Standard 30 120 CTT position diluent 9.999 -9.999

2 * ** Standard 30 120 CTT position diluent 9.999 -9.999

3 * ** Standard 30 120 CTT position diluent 9.999 -9.999

4 * ** Standard 30 120 CTT position diluent 9.999 -9.999

5 * ** Standard 30 120 CTT position diluent 9.999 -9.999

* Data entered by operator ** Concentration of standard

3. Order information C1I/AUS-000 1x 5 mL Antiserum 2x 25 mL Buffer MPS/STH-001 Protein Standard High, 1 mL MPS/STS-5X1 Protein Standard Set, 5 x 1 mL

139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL

APTEC DIAGNOSTICS 06.06.2006

APPLICATION NOTE ADVIA 1200

COMPLEMENT C3 BI (AUT-KIT) 1. Reagent preparation Sample: Ready for use Reagent: Buffer, ready for use Start: Antiserum, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point.

2. Analytical Parameters (Chemistry) TYPE #

Analytical conditions Sub-analy. conditions

R1 volume 90 Name C3C

R2 volume 0 Digits *

R3 volume 20 M-wave.L. 340

R4 volume 0 S-wave.L.

R1 diluent vol 0 Analy.Mthd EPA

R2 diluent vol 0 Calc.Mthd MSTD

R3 diluent vol 0 Qualit.judge Not do

R4 diluent vol 0 Calculation method setting

Serum reac.s.vol 4 M-DET.P.l 0

Serum dil.method A dilution 40

Serum dil.s.vol 30 41

Serum dil.volume 120 17

Serum dil.posit RTT position diluent 18

Reaction time 10 min. Check D.P.I. 0

Reagent 1 stir Weak Limit value 0.003

Reagent 2 stir Weak Variance 10.0

Reagent 3 stir Weak * Prozone

Reagent 4 stir Weak Prozone form NONE

Prozone limit

Reanalysis conditions Prozone judge

Serum reac.smp.vol (u) 3 M-DET.P.m

Serum dilut.method (u) NONE M-DET.P.n

Serum dil.smp.vol (u) 0 S-DET.P.p

Serum diluent vol (u) 0 S-DET.P.p

Serum diluent posi (u) 0 S-DET.r

Serum reac.smp.vol (d) 2 * Endpoint

Serum dilut.method (d) STD Re.absorb (u) 1.700

Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450

Serum diluent vol (d) 120

Serum diluent posi (d) 0

Standard settings Multi-STD

Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5

POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L

BLK *

1 * ** Standard 30 120 CTT position diluent 9.999 -9.999

2 * ** Standard 30 120 CTT position diluent 9.999 -9.999

3 * ** Standard 30 120 CTT position diluent 9.999 -9.999

4 * ** Standard 30 120 CTT position diluent 9.999 -9.999

5 * ** Standard 30 120 CTT position diluent 9.999 -9.999

* Data entered by operator ** Concentration of standard

3. Order information C3C/AUT-000 1 x 10 mL Antiserum 5 x 25 mL Buffer MPS/STS-5X1 Protein Standard Set, 5 x 1 mL

139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL

APTEC DIAGNOSTICS 19.02.2008

APPLICATION NOTE ADVIA 1200

CRP (250 – 50 KIT) 1. Reagent preparation Sample: Ready for use Reagent: Buffer, ready for use Start: Antiserum, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point.

2. Analytical Parameters (Chemistry) TYPE #

Analytical conditions Sub-analy. conditions

R1 volume 100 Name CRP

R2 volume 0 Digits *

R3 volume 20 M-wave.L. 340

R4 volume 0 S-wave.L.

R1 diluent vol 0 Analy.Mthd EPA

R2 diluent vol 0 Calc.Mthd MSTD

R3 diluent vol 0 Qualit.judge Not do

R4 diluent vol 0 Calculation method setting

Serum reac.s.vol 25 M-DET.P.l 0

Serum dil.method A dilution 40

Serum dil.s.vol 30 41

Serum dil.volume 120 17

Serum dil.posit RTT position diluent 18

Reaction time 10 min. Check D.P.I. 0

Reagent 1 stir Weak Limit value 0.003

Reagent 2 stir Weak Variance 10.0

Reagent 3 stir Weak * Prozone

Reagent 4 stir Weak Prozone form NONE

Prozone limit

Reanalysis conditions Prozone judge

Serum reac.smp.vol (u) 10 M-DET.P.m

Serum dilut.method (u) NONE M-DET.P.n

Serum dil.smp.vol (u) 0 S-DET.P.p

Serum diluent vol (u) 0 S-DET.P.p

Serum diluent posi (u) 0 S-DET.r

Serum reac.smp.vol (d) 5 * Endpoint

Serum dilut.method (d) STD Re.absorb (u) 1.700

Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450

Serum diluent vol (d) 120

Serum diluent posi (d) 0

Standard settings Multi-STD

Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 6

POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L

BLK *

1 * ** Special 2 148 CTT position diluent 9.999 -9.999

2 * ** Special 3 117 CTT position diluent 9.999 -9.999

3 * ** Special 5 95 CTT position diluent 9.999 -9.999

4 * ** Special 10 90 CTT position diluent 9.999 -9.999

5 * ** Standard 30 120 CTT position diluent 9.999 -9.999

* Data entered by operator ** Concentration of standard

3. Order information 117C004 1 x 10 mL Antiserum 2 x 25 mL Buffer CRP/STH-001 CRP Standard High, 1 mL CRP/COL-001 CRP Control Low, 1 mL CRP/COH-001 CRP Control High, 1 mL

139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL

APTEC DIAGNOSTICS 19.02.2008

APTEC DIAGNOSTICS 20.07.2010 APPLICATION TO BE VALIDATED BY THE USER

APPLICATION NOTE ADVIA 1200

CRP ULTRA SENSITIVE N-DIL (U2A–KIT) LATEX METHOD

1. Reagent preparation Sample: Ready for use Reagent: Buffer, ready for use Start: Antiserum, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point.

2. Analytical Parameters (Chemistry) TYPE #

Analytical conditions Sub-analy. conditions

R1 volume 100 Name CRP

R2 volume 0 Digits *

R3 volume 24 M-wave.L. 600

R4 volume 0 S-wave.L.

R1 diluent vol 0 Analy.Mthd EPA

R2 diluent vol 0 Calc.Mthd MSTD

R3 diluent vol 0 Qualit.judge Not do

R4 diluent vol 0 Calculation method setting

Serum reac.s.vol 4 M-DET.P.l 0

Serum dil.method A dilution 40

Serum dil.s.vol 30 41

Serum dil.volume 120 17

Serum dil.posit RTT position diluent 18

Reaction time 10 min. Check D.P.I. 0

Reagent 1 stir Weak Limit value 0.003

Reagent 2 stir Weak Variance 10.0

Reagent 3 stir Weak * Prozone

Reagent 4 stir Weak Prozone form NONE

Prozone limit

Reanalysis conditions Prozone judge

Serum reac.smp.vol (u) 2 M-DET.P.m

Serum dilut.method (u) NONE M-DET.P.n

Serum dil.smp.vol (u) 0 S-DET.P.p

Serum diluent vol (u) 0 S-DET.P.p

Serum diluent posi (u) 0 S-DET.r

Serum reac.smp.vol (d) 2 * Endpoint

Serum dilut.method (d) STD Re.absorb (u) 1.700

Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450

Serum diluent vol (d) 120

Serum diluent posi (d) 0

Standard settings Multi-STD

Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 6

POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L

BLK *

1 * ** Special 2 148 CTT position diluent 9.999 -9.999

2 * ** Special 3 117 CTT position diluent 9.999 -9.999

3 * ** Special 5 95 CTT position diluent 9.999 -9.999

4 * ** Special 10 90 CTT position diluent 9.999 -9.999

5 * ** Standard 30 120 CTT position diluent 9.999 -9.999

* Data entered by operator ** Concentration of standard

3. Order information CRP/U2A-000 1 x 10 mL Latex 2 x 25 mL Buffer CRP/SHU-001 CRP US Standard High ,1 mL CRP/COU-001 CRP Control Ultra low, 1mL CRP/COL-001 CRP Control Low , 1 mL CRP/COH-001 CRP Control High , 1 mL 139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1mL

APTEC DIAGNOSTICS 19.02.2008

APPLICATION NOTE ADVIA 1200

IGA MONOREAGENT 2

ND GENERATION

1. Reagent preparation Sample: Ready for use Reagent (R1): Monoreagent, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point.

2. Analytical Parameters (Chemistry) TYPE #

Analytical conditions Sub-analy. conditions

R1 volume 250 Name IGA

R2 volume 0 Digits *

R3 volume 0 M-wave.L. 340

R4 volume 0 S-wave.L. 694

R1 diluent vol 0 Analy.Mthd EPA

R2 diluent vol 0 Calc.Mthd MSTD

R3 diluent vol 0 Qualit.judge Not do

R4 diluent vol 0 Calculation method setting

Serum reac.s.vol 4 M-DET.P.l 0

Serum dil.method SPECIAL M-DET.P.m 40

Serum dil.s.vol 10 M-DET.P.n 41

Serum dil.volume 90 S-DET.P.p 0

Serum dil.posit RTT position diluent S-DET.P.r. 0

Reaction time 10 min. Check D.P.I. 0

Reagent 1 stir Weak Limit value 0.003

Reagent 2 stir Weak Variance 10.0

Reagent 3 stir Weak * Prozone

Reagent 4 stir Weak Prozone form NONE

Prozone limit

Reanalysis conditions Prozone judge

Serum reac.smp.vol (u) 4 M-DET.P.m

Serum dilut.method (u) STD M-DET.P.n

Serum dil.smp.vol (u) 30 S-DET.P.p

Serum diluent vol (u) 120 S-DET.P.p

Serum diluent posi (u) 0 S-DET.r

Serum reac.smp.vol (d) 2 * Endpoint

Serum dilut.method (d) SPECIAL Re.absorb (u) 1.700

Serum dil.smp.vol (d) 5 Re.absorb (d) -1.450

Serum diluent vol (d) 95

Serum diluent posi (d) 0

Standard settings Multi-STD

Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5

POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L

BLK *

1 * ** Special 2 148 CTT position diluent 9.999 -9.999

2 * ** Special 3 117 CTT position diluent 9.999 -9.999

3 * ** Special 5 95 CTT position diluent 9.999 -9.999

4 * ** Special 10 90 CTT position diluent 9.999 -9.999

5

* Data entered by operator ** Concentration of standard

3. Order information 104A002 25 mL Monoreagent MPH/STH-001 Protein Standard High, 1 mL

139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL

APTEC DIAGNOSTICS 19.02.2008

APPLICATION NOTE ADVIA 1200

IGG MONOREAGENT 2

ND GENERATION

1. Reagent preparation Sample: Ready for use Reagent (R1): Monoreagent, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point.

2. Analytical Parameters (Chemistry) TYPE #

Analytical conditions Sub-analy. conditions

R1 volume 250 Name IGG

R2 volume 0 Digits *

R3 volume 0 M-wave.L. 340

R4 volume 0 S-wave.L. 694

R1 diluent vol 0 Analy.Mthd EPA

R2 diluent vol 0 Calc.Mthd MSTD

R3 diluent vol 0 Qualit.judge Not do

R4 diluent vol 0 Calculation method setting

Serum reac.s.vol 2 M-DET.P.l 0

Serum dil.method SPECIAL M-DET.P.m 40

Serum dil.s.vol 10 M-DET.P.n 41

Serum dil.volume 90 S-DET.P.p 0

Serum dil.posit RTT position diluent S-DET.P.r. 0

Reaction time 10 min. Check D.P.I. 0

Reagent 1 stir Weak Limit value 0.003

Reagent 2 stir Weak Variance 10.0

Reagent 3 stir Weak * Prozone

Reagent 4 stir Weak Prozone form NONE

Prozone limit

Reanalysis conditions Prozone judge

Serum reac.smp.vol (u) 4 M-DET.P.m

Serum dilut.method (u) STD M-DET.P.n

Serum dil.smp.vol (u) 30 S-DET.P.p

Serum diluent vol (u) 120 S-DET.P.p

Serum diluent posi (u) 0 S-DET.r

Serum reac.smp.vol (d) 2 * Endpoint

Serum dilut.method (d) SPECIAL Re.absorb (u) 1.700

Serum dil.smp.vol (d) 5 Re.absorb (d) -1.450

Serum diluent vol (d) 95

Serum diluent posi (d) 0

Standard settings Multi-STD

Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5

POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L

BLK *

1 * ** Special 2 148 CTT position diluent 9.999 -9.999

2 * ** Special 3 117 CTT position diluent 9.999 -9.999

3 * ** Special 5 95 CTT position diluent 9.999 -9.999

4 * ** Special 10 90 CTT position diluent 9.999 -9.999

5

* Data entered by operator ** Concentration of standard

3. Order information 105A002 25 mL Monoreagent MPH/STH-001 Protein Standard High, 1 mL

139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL

APTEC DIAGNOSTICS 27.11.2012

APPLICATION NOTE ADVIA 1200

IgM KIT 2nd

Generation 1. Reagent preparation Sample: Ready for use Reagent: Buffer, ready for use Start: Antiserum, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point.

2. Analytical Parameters (Chemistry) TYPE #

Analytical conditions Sub-analy. conditions

R1 volume 150 Name IgM

R2 volume 0 Digits *

R3 volume 30 M-wave.L. 340

R4 volume 0 S-wave.L.

R1 diluent vol 0 Analy.Mthd EPA

R2 diluent vol 0 Calc.Mthd MSTD

R3 diluent vol 0 Qualit.judge Not do

R4 diluent vol 0 Calculation method setting

Serum reac.s.vol 5 M-DET.P.l 0

Serum dil.method A dilution 40

Serum dil.s.vol 30 41

Serum dil.volume 120 17

Serum dil.posit RTT position diluent 18

Reaction time 10 min. Check D.P.I. 0

Reagent 1 stir Weak Limit value 0.003

Reagent 2 stir Weak Variance 10.0

Reagent 3 stir Weak * Prozone

Reagent 4 stir Weak Prozone form NONE

Prozone limit

Reanalysis conditions Prozone judge

Serum reac.smp.vol (u) 2 M-DET.P.m

Serum dilut.method (u) NONE M-DET.P.n

Serum dil.smp.vol (u) 0 S-DET.P.p

Serum diluent vol (u) 0 S-DET.P.p

Serum diluent posi (u) 0 S-DET.r

Serum reac.smp.vol (d) 2 * Endpoint

Serum dilut.method (d) STD Re.absorb (u) 1.700

Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450

Serum diluent vol (d) 120

Serum diluent posi (d) 0

Standard settings Multi-STD

Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5

POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L

BLK *

1 * ** Standard 30 120 CTT position diluent 9.999 -9.999

2 * ** Standard 30 120 CTT position diluent 9.999 -9.999

3 * ** Standard 30 120 CTT position diluent 9.999 -9.999

4 * ** Standard 30 120 CTT position diluent 9.999 -9.999

5 * ** Standard 30 120 CTT position diluent 9.999 -9.999

* Data entered by operator ** Concentration of standard

3. Order information 106C002 1 x 10 mL Antiserum

5 x 25 mL Buffer MPS/STS-5X1 Protein Standard Set, 5 x 1 mL 139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL

APTEC DIAGNOSTICS 19.02.2008

APPLICATION NOTE ADVIA 1200

IGM MONOREAGENT 2

ND GENERATION

1. Reagent preparation Sample: Ready for use Reagent (R1): Monoreagent, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point.

2. Analytical Parameters (Chemistry) TYPE #

Analytical conditions Sub-analy. conditions

R1 volume 250 Name IGM

R2 volume 0 Digits *

R3 volume 0 M-wave.L. 340

R4 volume 0 S-wave.L. 694

R1 diluent vol 0 Analy.Mthd EPA

R2 diluent vol 0 Calc.Mthd MSTD

R3 diluent vol 0 Qualit.judge Not do

R4 diluent vol 0 Calculation method setting

Serum reac.s.vol 20 M-DET.P.l 0

Serum dil.method SPECIAL M-DET.P.m 40

Serum dil.s.vol 10 M-DET.P.n 41

Serum dil.volume 90 S-DET.P.p 0

Serum dil.posit RTT position diluent S-DET.P.r. 0

Reaction time 10 min. Check D.P.I. 0

Reagent 1 stir Weak Limit value 0.003

Reagent 2 stir Weak Variance 10.0

Reagent 3 stir Weak * Prozone

Reagent 4 stir Weak Prozone form NONE

Prozone limit

Reanalysis conditions Prozone judge

Serum reac.smp.vol (u) 20 M-DET.P.m

Serum dilut.method (u) STD M-DET.P.n

Serum dil.smp.vol (u) 30 S-DET.P.p

Serum diluent vol (u) 120 S-DET.P.p

Serum diluent posi (u) 0 S-DET.r

Serum reac.smp.vol (d) 10 * Endpoint

Serum dilut.method (d) SPECIAL Re.absorb (u) 1.700

Serum dil.smp.vol (d) 5 Re.absorb (d) -1.450

Serum diluent vol (d) 95

Serum diluent posi (d) 0

Standard settings Multi-STD

Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5

POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L

BLK *

1 * ** Special 2 148 CTT position diluent 9.999 -9.999

2 * ** Special 3 117 CTT position diluent 9.999 -9.999

3 * ** Special 5 95 CTT position diluent 9.999 -9.999

4 * ** Special 10 90 CTT position diluent 9.999 -9.999

5

* Data entered by operator ** Concentration of standard

3. Order information 106A002 25 mL Monoreagent MPH/STH-001 Protein Standard High, 1 mL

139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL

APTEC DIAGNOSTICS 19.02.2008

APPLICATION NOTE ADVIA 1200

MICROALBUMIN (250 – 50 KIT) 1. Reagent preparation Sample: Centrifuged urine, ready for use Reagent: Buffer, ready for use Start: Antiserum, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point.

2. Analytical Parameters (Chemistry) TYPE #

Analytical conditions Sub-analy. conditions

R1 volume 100 Name MAL

R2 volume 0 Digits *

R3 volume 20 M-wave.L. 340

R4 volume 0 S-wave.L.

R1 diluent vol 0 Analy.Mthd EPA

R2 diluent vol 0 Calc.Mthd MSTD

R3 diluent vol 0 Qualit.judge Not do

R4 diluent vol 0 Calculation method setting

Serum reac.s.vol 10 M-DET.P.l 0

Serum dil.method A dilution 40

Serum dil.s.vol 30 41

Serum dil.volume 120 17

Serum dil.posit RTT position diluent 18

Reaction time 10 min. Check D.P.I. 0

Reagent 1 stir Weak Limit value 0.003

Reagent 2 stir Weak Variance 10.0

Reagent 3 stir Weak * Prozone

Reagent 4 stir Weak Prozone form NONE

Prozone limit

Reanalysis conditions Prozone judge

Serum reac.smp.vol (u) 4 M-DET.P.m

Serum dilut.method (u) NONE M-DET.P.n

Serum dil.smp.vol (u) 0 S-DET.P.p

Serum diluent vol (u) 0 S-DET.P.p

Serum diluent posi (u) 0 S-DET.r

Serum reac.smp.vol (d) 2 * Endpoint

Serum dilut.method (d) STD Re.absorb (u) 1.700

Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450

Serum diluent vol (d) 120

Serum diluent posi (d) 0

Standard settings Multi-STD

Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 6

POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L

BLK *

1 * ** Special 2 148 CTT position diluent 9.999 -9.999

2 * ** Special 3 117 CTT position diluent 9.999 -9.999

3 * ** Special 5 95 CTT position diluent 9.999 -9.999

4 * ** Special 10 90 CTT position diluent 9.999 -9.999

5 * ** Standard 30 120 CTT position diluent 9.999 -9.999

* Data entered by operator ** Concentration of standard

3. Order information 102C004 1 x 10 mL Antiserum 2 x 25 mL Buffer MAL/STD-001 Microalbumin standard, 1 mL MAL/CON-001 Microalbumin control, 1 mL MAL/CON-005 Microalbumin control, 5 mL

APTEC DIAGNOSTICS 19.02.2008

APPLICATION NOTE ADVIA 1200

RF 3RD

GENERATION Hu Agg IgG Method

1. Reagent preparation Sample: Ready for use Reagent: Buffer, ready for use Start: Reagent, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point.

2. Analytical Parameters (Chemistry) TYPE #

Analytical conditions Sub-analy. conditions

R1 volume 100 Name RF

R2 volume 0 Digits *

R3 volume 20 M-wave.L. 340

R4 volume 0 S-wave.L.

R1 diluent vol 0 Analy.Mthd EPA

R2 diluent vol 0 Calc.Mthd MSTD

R3 diluent vol 0 Qualit.judge Not do

R4 diluent vol 0 Calculation method setting

Serum reac.s.vol 30 M-DET.P.l 0

Serum dil.method A dilution 40

Serum dil.s.vol 30 41

Serum dil.volume 120 17

Serum dil.posit RTT position diluent 18

Reaction time 10 min. Check D.P.I. 0

Reagent 1 stir Weak Limit value 0.003

Reagent 2 stir Weak Variance 10.0

Reagent 3 stir Weak * Prozone

Reagent 4 stir Weak Prozone form NONE

Prozone limit

Reanalysis conditions Prozone judge

Serum reac.smp.vol (u) 15 M-DET.P.m

Serum dilut.method (u) NONE M-DET.P.n

Serum dil.smp.vol (u) 0 S-DET.P.p

Serum diluent vol (u) 0 S-DET.P.p

Serum diluent posi (u) 0 S-DET.r

Serum reac.smp.vol (d) 10 * Endpoint

Serum dilut.method (d) STD Re.absorb (u) 1.700

Serum dil.smp.vol (d) 30 Re.absorb (d) -1.450

Serum diluent vol (d) 120

Serum diluent posi (d) 0

Standard settings Multi-STD

Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 6

POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L

BLK *

1 * ** Special 2 148 CTT position diluent 9.999 -9.999

2 * ** Special 3 117 CTT position diluent 9.999 -9.999

3 * ** Special 5 95 CTT position diluent 9.999 -9.999

4 * ** Special 10 90 CTT position diluent 9.999 -9.999

5 * ** Standard 30 120 CTT position diluent 9.999 -9.999

* Data entered by operator ** Concentration of standard

3. Order information 100C011 1 x 10 mL Reagent 2 x 25 mL Buffer RHF/SST-001 RF Standard Super High, 1 mL RHF/CON-001 RF Control, 1 mL

139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL

APTEC DIAGNOSTICS 19.02.2008

APPLICATION NOTE ADVIA 1200

TRF MONOREAGENT 2

ND GENERATION

1. Reagent preparation Sample: Ready for use Reagent (R1): Monoreagent, ready for use Calibrator: Ready for use. Use saline 9 g/L as zero point.

2. Analytical Parameters (Chemistry) TYPE #

Analytical conditions Sub-analy. conditions

R1 volume 250 Name TRF

R2 volume 0 Digits *

R3 volume 0 M-wave.L. 340

R4 volume 0 S-wave.L. 694

R1 diluent vol 0 Analy.Mthd EPA

R2 diluent vol 0 Calc.Mthd MSTD

R3 diluent vol 0 Qualit.judge Not do

R4 diluent vol 0 Calculation method setting

Serum reac.s.vol 7 M-DET.P.l 0

Serum dil.method SPECIAL M-DET.P.m 40

Serum dil.s.vol 10 M-DET.P.n 41

Serum dil.volume 90 S-DET.P.p 0

Serum dil.posit RTT position diluent S-DET.P.r. 0

Reaction time 10 min. Check D.P.I. 0

Reagent 1 stir Weak Limit value 0.003

Reagent 2 stir Weak Variance 10.0

Reagent 3 stir Weak * Prozone

Reagent 4 stir Weak Prozone form NONE

Prozone limit

Reanalysis conditions Prozone judge

Serum reac.smp.vol (u) 7 M-DET.P.m

Serum dilut.method (u) STD M-DET.P.n

Serum dil.smp.vol (u) 30 S-DET.P.p

Serum diluent vol (u) 120 S-DET.P.p

Serum diluent posi (u) 0 S-DET.r

Serum reac.smp.vol (d) 7 * Endpoint

Serum dilut.method (d) SPECIAL Re.absorb (u) 1.700

Serum dil.smp.vol (d) 5 Re.absorb (d) -1.450

Serum diluent vol (d) 95

Serum diluent posi (d) 0

Standard settings Multi-STD

Formula LOGIT– LOG3 Axis conv. NO CONVERT Points 5

POS Coeff (FV) Dil.method Dil.smp.vol Diluent vol. Diluent pos. STD-H STD-L

BLK *

1 * ** Special 2 148 CTT position diluent 9.999 -9.999

2 * ** Special 3 117 CTT position diluent 9.999 -9.999

3 * ** Special 5 95 CTT position diluent 9.999 -9.999

4 * ** Special 10 90 CTT position diluent 9.999 -9.999

5

* Data entered by operator ** Concentration of standard

3. Order information 109A002 25 mL Monoreagent MPH/STH-001 Protein Standard High, 1 mL

139F003 Immunology Control Low, 1mL 139F002 Immunology Control High, 1 mL