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FDA approves all-in-one screening test for three intestinal parasites
The FDA has granted 510(k) marketing clearance to TechLab’s Tri-Combo Parasite Screen test, an all-in-one test for Giardia, Cryptosporidium, and Entamoeba histolytica, the three most common intestinal protozoan parasites and the most common parasitic causes of diarrhea in the U.S., according to a press release.
The test is indicated as an aid in diagnosing GI infection when giardiasis, cryptosporidiosis and amebiasis is suspected.
It is an enzyme immunoassay that provides simultaneous qualitative detection of these parasites’ antigens in stool samples. It also specifically detects pathogenic E. histolytica without cross reacting with non-pathogenic E. dispar.
“This new and unique assay will make testing for the three most common causes of parasitic gastroenteritis more efficient and cost-effective,” David Lyerly, PhD, TechLab’s chief scientific officer, said in the press release.
Disclosures: Lyerly is employed by TechLab.