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FDA clears rapid diagnostic test for E. histolytica
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The FDA has granted 510(k) clearance to TechLab’s E. histolytica Quik Chek test, a rapid test to help clinicians diagnose amebiasis caused by the intestinal parasite E. histolytica without cross-reacting with the non-pathogenic Entamoeba dispar, the company announced.
Because E. histolytica is morphologically identical to E. dispar, it is difficult to make an accurate diagnosis, and other tests and microscopy are unable to differentiate between the two, according to a press release. This new test is “a rapid assay for the qualitative detection of E. histolytica in fecal samples [that] targets an adhesin protein unique to E. histolytica.”
The test can be paired with the company’s Giardia/Cryptosporidium test to provide a complete triple parasite screen for common intestinal parasites, the company noted.
E. histolytica annually infects about 50 million people, and can cause amebiasis, which is characterized by bloody diarrhea, colitis and liver abscesses. As many as 100,000 people die of this disease per year, and 12% of travelers who develop acute diarrhea after returning from the developing world are diagnosed, according to the press release.