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AMPLISureTM Gastro
Gastrointestinal Pathogen Testing
1 Sample, 1 Test, 11 Results
Confidence in results.
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 hospitals 6
• 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
ble
• 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
Viruses
Parasites
Campylobacter
Norovirus GI/GII
Giardia lamblia
Clostridium difficile, Toxin A/B
with reflex to Epi
027/NAP1/Bl ribotyping
Rotavirus A
Cryptosporidium
Escherichia coli O157
Ova and Parasites
Screen
Enterotoxigenic E. coli
(ETEC) LT/ST
Shiga-like Toxin producing
E. coli (STEC) stx 1/stx 2
Salmonella
Shigella
Routine flora screening
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
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
•
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
•
•
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
•
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 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
AMPLISureTM Gastro’s high
negative predictive value
affords the ability to rule out
>90% of the infectious causes
of diarrhea
AMPLISureTM Gastro:
Designed for Patient Assurance
A negative predictive value of 99.9%
gives confidence in the value of a negative result.
Analyte
True Negative (TN)
Specimens (n)
False Negative (FN)
Specimens (n)
Estimated NPV:
TN/ (TN + FN)
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%
12289
18
All Analytes
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
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)
AMPLISure
TM
Gastro
REFERENCE:
1.
2.
3.
4.
5.
6.
7.
8.
World Gastroenterology Organisation practice guideline: Acute diarrhea, March 2008. (http://www.worldgastroenterology.org/assets/downloads/en/pdf/guidelines/01_acute_diarrhea.pdf )
CDC, National Center for Zoonotic, Vector-borne and Enteric Diseases.
Bern et al. 1992. The magnitude of the global problem of diarrheal disease: a ten-year Update Bulletin. World Health Organisation. 70:705–714.
http://www.who.int/mediacentre/factsheets/fs330/en/index.html
U.S. Dept. of Health and Human Services. (2010). National Statistics on Intestinal Infections.
Chadwick P.R. et al. Journal of Hospital Infections (2000) 45:1-10.6.
Fact sheet no. 194 about microbial resistance at www.who.int/mediacentre/factsheets/
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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