FDA Approves Kit To Test 11 Causes of Gastroenteritis At Once

The Food and Drug Administration (FDA) has announced its approval to market a new test that can identify any of 11 potential causes of infectious gastroenteritis simultaneously from a single patient sample. The xTAG Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test which detects any of seven bacteria, including Salmonella; three forms of E. Coli; Clostridium difficile; Campylobacter two parasites, i.e., Cryptosporidium and Giardiabacteria; and two viruses, specifically, Norovirus and Rotavirus A. It is made by Luminex, Inc. of Austin, Texas.

Infectious gastroenteritis is an inflammation of the stomach and intestines caused by any of a variety of sources, including viruses, bacteria, and parasites. Common symptoms include vomiting and diarrhea, which often are more severe in infants, the elderly, or people with compromised immune systems. The disease is easily spread through person-to-person contact and from contaminated water, surfaces, or food.

According to the Centers for Disease Control and Prevention, the number of deaths caused by infectious gastroenteritis grew from fewer than 7,000 in 1999 to more than 17,000 in 2007. Together, Norovirus and Clostridium difficile (C. difficile) accounted for about two-thirds of the deaths. The new test is expected to help clinicians find the cause of a patient’s illness more quickly and allow public health officials to identify and investigate the source of new outbreaks. Because of a risk of false positives, positive results should be confirmed with additional testing.