Rapid Identification of Gastro Pathogens Directly from Stool

On January 14, 2013, that the U.S. FDA approved a device allowing detection of multiple gastrointestinal pathogens from a single sample of feces. 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:

Bacteria and toxins

Campylobacter
Clostridum difficile Toxin A/B
Enterotoxigenic E. coli (ETEC) LT/ST
Shiga-like Toxin producing (STEC) E. Coli sfx1/sfx2
Salmonella
Shigella

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 1,407 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.”

In Europe, the company reports the sensitivity of detection of individual pathogens is reported to range 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
  2. http://www.luminexcorp.com/Products/Assays/ClinicalDiagnostics/xTAGGPP/index.htm IDAlert 1/15/2013