AMPLISureTM Gastro

Gastrointestinal Pathogen Testing 1 Sample, 1 Test, 11 Results

Confidence in results.

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Gastroenteritis: A Serious Medical and Economic Burden

A variety of bacterial, viral, and parasitic organisms cause

infectious gastroenteritis

• Diagnostically it’s difficult to differentiate due to similar symptoms1,2

• 80% of all cases of diarrhea are currently unidentified2

Diarrhea inflicts a significant toll on the health care system and imparts a

high degree of morbidity and mortality in select populations3

• Globally, there are an estimated 2 billion cases of diarrheal disease every

year which kill approximately 1.8 million people annually4

• In 2010, the U.S. associated cost for the 237,000+ patients suffering from

gastrointestinal infections was over $6 billion5

Consequence of outbreaks of gastroenteritis in hospitals6

• Hospital ward closures and major disruption in hospital activity

(e.g. bed blocking, loss of revenue)

Diarrhea can also have a major impact in society

• Significant number of days lost at school or work

Inappropriate and irrational use of medicines provides favorable

conditions for resistant microorganisms to emerge and spread

• When infections become resistant to first-line medicines, more

expensive therapies must be used.

• The longer duration of illness and treatment, often in hospitals,

increases health-care costs and the financial burden to families and

societies7

The Largest FDA-approved panel for 11 of the Most Common Causes of Infectious Diarrhea

AMPLISureTM Gastro, Gastro LT, and Gastro O&P:

• Get Fast, Comprehensive Results: Detect and identify

≥90% of the causative bacterial, viral and parasitic

agents of gastroenteritis2,8

• Simplify Your Detection Process: One test provides

answers for 11 pathogens as well as routine flora

screening

• Flexible ordering capabilities: The full Gastro panel,

Gastro LT (traditional stool culture), and Gastro O&P

Bacteria & Bacterial Toxins

Campylobacter

Clostridium difficile, Toxin A/B with reflex to Epi 027/NAP1/Bl ribotyping

Escherichia coli O157

Enterotoxigenic E. coli

(ETEC) LT/ST

Shiga-like Toxin producing

E. coli (STEC) stx 1/stx 2

Salmonella

Shigella Routine flora screening

Viruses

Norovirus GI/GII

Rotavirus A

Parasites

Giardia lamblia Cryptosporidium Ova and Parasites Screen

AMPLISureTM Gastro

MedLabs Test Code: P2002MG

Specimen Requirement: Stool (sterile container)

Specimen Stability: 24 hours @ 2-4 degrees C

Components: All but manual O&P screen

AMPLISureTM Gastro LT

MedLabs Test Code: P2002MG

Specimen Requirement: Stool (sterile container)

Specimen Stability: 24 hours @ 2-4 degrees C

Components: Campylobacter, E. coli O157,

STEC, Salmonella, Shigella, flora screen

AMPLISureTM Gastro O&P

MedLabs Test Code: P2002MG

Specimen Requirement: Stool (sterile container)

Specimen Stability: 24 hours @ 2-4 degrees C

Components: Giardia, Cryptosporidium, O&P screen

GI Diagnostic Challenges

and Clinical Consequences

Accurate detection of GI pathogens may improve patient outcomes, isolate patients appropriately, and act fast in outbreak situations.

Challenge Consequence Solution

• Many causative agents of diarrhea

that are difficult to diagnose as

symptoms are similar

• Risk of delayed or wrong

patient treatment

• Risk of improper and ineffective

treatment with side effects,

patient anxiety, inappropriate

use of antibiotics and potential

for antibiotic resistance

• AMPLISureTM Gastro

simultaneously detects

and identifies the bacterial,

viral, and parasitic

pathogens responsible for

over 90% of cases of

infectious diarrhea2

• Patient treatment can be

optimized more quickly with

improved outcomes

• Traditional laboratory methods are

not sensitive or specific enough.

Moreover, not all samples are

tested for all diarrhea-causing

pathogens. Together this results

in a false negative test result.

• Risk of delayed or wrong

patient treatment

• Pressure on isolation facilities

until results are available.

Potential for outbreaks if

patients with communicable

infectious gastroenteritis are

not isolated

• AMPLISureTM Gastro provides

higher and better diagnostic

yield for more appropriate

patient management

• Optimized bed management

helps to reduce costs and frees

up beds for new patients

requiring isolation

• Current methodologies and

requesting patterns mean that

some results can take more than

1 week

• Control and prevention of outbreaks

• Incorrect diagnosis impacting

treatment and bed isolation

management

• Treatment side effects,

antibiotic resistance,

patient anxiety

• Prolonged needless isolation

or lack of isolation with risk

of outbreaks

• AMPLISureTM Gastro’s high

negative predictive value

affords the ability to rule out

>90% of the infectious causes

of diarrhea

Analyte True Negative (TN) False Negative (FN) Estimated NPV:

Specimens (n) Specimens (n) TN/ (TN + FN)

AMPLISureTM Gastro:

Designed for Patient Assurance

A negative predictive value of 99.9% gives confidence in the value of a negative result.

Campylobacter 1155 0 100%

Cryptosporidium 1131 1 99.9%

E. coli O157 1158 0 100%

Giardia 1132 0 100%

Norovirus GI/GII 1023 4 99.6%

Salmonella 1143 0 100%

Shigella 1154 0 100%

C. difficile Toxin A/B 922 7 99.2%

ETEC 1156 6 99.5%

Rotavirus A 1162 0 100%

STEC 1153 0 100%

All Analytes 12289 18 99.9%

AMPLISureTM Gastro:

Transforming GI Diagnostics

1 Sample, 1 Test, 11 Results – More results per test than any other method, in time to affect patient care.

Method Tests For Percent Positive

Stool culture Single or a few bacterial pathogens

per test

Up to 6%

(Slutsker, 1997)

Ova & parasite (O&P) exam Parasitic pathogens Up to 3%

(Fotedar, 2007; Tuncay 2007)

Rapid tests Single pathogen per test Varies

Real-time PCR Typically 1-3 pathogens/virulence

factors per test

Varies; depends on the pathogen

target, performance of assay, and

number of assays

ELISA Single antigen/antibody per test Varies

AMPLISureTM Gastro 11 baterial, viral, and parasitic

pathogens in a single test as well

as routine flora screening

Greater than or equal to 35%- All

11 targets (Luminex Corp., 2013)

REFERENCE:

1. World Gastroenterology Organisation practice guideline: Acute diarrhea, March 2008. (http://www.worldgastroenterology.org/assets/downloads/en/pdf/guidelines/01_acute_diarrhea.pdf )

2. CDC, National Center for Zoonotic, Vector-borne and Enteric Diseases.

3. Bern et al. 1992. The magnitude of the global problem of diarrheal disease: a ten-year Update Bulletin. World Health Organisation. 70:705–714.

4. http://www.who.int/mediacentre/factsheets/fs330/en/index.html

5. U.S. Dept. of Health and Human Services. (2010). National Statistics on Intestinal Infections.

6. Chadwick P.R. et al. Journal of Hospital Infections (2000) 45:1-10.6.

7. Fact sheet no. 194 about microbial resistance at www.who.int/mediacentre/factsheets/

8. Luminex Corp. (2013). U.S. Clinical Site Data. xTAG GPP Package Insert.

For more information about gastroenteritis, visit www.gastroenteritis.com or visit www.medlabsgenetics.com

To learn more about the U.S. trials, go to www.luminexcorp.com/GIAnswers.

For In Vitro Diagnostic Use. Reagents available through the Luminex Corporation.

©2013 MedLabs Genetics. All rights reserved. The AMPLISure TM trademark and all logos and images contained within are the property of MedLabs Genetics.

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