A test that can detect multiple causes of infectious gastroenteritis in one stool sample has been cleared for marketing by the Food and Drug Administration.
The xTAG Gastrointestinal Pathogen Panel (GPP), a multiplexed nucleic acid test, is the "first test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample," the agency said in a Jan. 14 statement announcing the approval.
Courtesy CDC/Dr. Gilda Jones
The enterotoxin, CPE, is the principal toxin involved in foodborne illness. is a spore-forming bacteria that can be part of the normal intestinal flora in as many as 50% of children under age two.
The xTAG GPP tests for the bacteria Campylobacter, Clostridium difficile toxin A/B, Escherichia coli O157, enterotoxigenic E. coli (ETEC) LT/ST, Salmonella, Shigella, and Shiga-like toxin-producing E. coli (STEC) stx1/stx2; the viruses norovirus and rotavirus A; and the parasites Cryptosporidium and Giardia lamblia.
This test can help clinicians identify and treat the cause of gastroenteritis in patients more quickly, and "could also allow clinicians and public health professionals to more quickly identify and investigate the source of potential gastroenteritis outbreaks," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, said in the statement.
In studies conducted by the manufacturer, Luminex, results of the xTAG GPP were "comparable" with the results of individual tests for the 11 pathogens in stool samples from 1,407 patients with suspected infectious gastroenteritis, 313 samples from pediatric patients with suspected infectious gastroenteritis, and 203 samples from patients with confirmed cases of infectious gastroenteritis, according to the FDA. Because of the risk of false positives, "all positive results from the xTAG GPP need to be confirmed by additional testing," the agency’s announcement said.
The test, which is now available in the United States, can provide multiple results within 5 hours. It is the first and most comprehensive multiplexed product of its kind in the United States, according to a statement from Luminex.
The FDA cites data from the Centers for Disease Control and Prevention reporting that the number of deaths associated with gastroenteritis increased from nearly 7,000 to more than 17,000 per year between 1999 and 2007 in the United States. Two-thirds of the deaths were attributed to norovirus and C. difficile.