Brief Reports
Rapid Identification of Gastro Pathogens Directly from Stool
On January 14, 2013, the FDA approved a device allowing detection of multiple gastrointestinal pathogens from a single sample of feces.1 The Luminex xTAG Gastrointestinal Pathogen Panel (GPP) is a qualitative PCR that can simultaneously detect 11 different viral, parasitic, or bacterial pathogens or toxins in stool specimens, including the following:2
Bacteria and toxins
- Campylobacter
- Clostridium difficile toxin A/B
- Escherichia coli O157
- Enterotoxigenic E. coli (ETEC) LT/ST
- Salmonella
- Shigella
- Shiga-like toxin producing E. Coli stx 1/stx 2
Viruses
- Norovirus GI/GII
- Rotavirus A
Protozoa
- Giardia
- Cryptosporidium
- Entamoeba histolytica
Systems sold in Canada and Europe also detect Vibrio cholerae, Yersinia enterocolitica, and adenovirus 40/41.
According to the FDA, “The manufacturer demonstrated the performance of the xTAG GPP by collecting samples from 1407 patients with suspected infectious gastroenteritis and comparing the xTAG GPP results to individual tests that are known to separately and reliably detect the 11 viruses, bacteria, or parasites associated with the xTAG GPP. The manufacturer also ran the test on 203 samples from patients with previously confirmed infectious gastroenteritis, and 313 additional specimens from pediatric patients with suspected infectious gastroenteritis. Results were comparable to the individual tests. Due to the risk of false positives, all positive results from the xTAG GPP need to be confirmed by additional testing.”1
In Europe, the company reports that the sensitivity of detection of individual pathogens ranges from 87.5% to 100%. Testing systems such as these represent significant advances, but will only be useful if they are readily available to the practicing clinician and are reasonably priced.
References
1. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm335274.htm. Accessed April 11, 2013.
2. http://www.luminexcorp.com/Products/Assays/ClinicalDiagnostics/xTAGGPP/. Accessed April 11, 2013.
On January 14, 2013, the FDA approved a device allowing detection of multiple gastrointestinal pathogens from a single sample of feces.1You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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