NEW YORK (360Dx) – Techlab announced on Tuesday that it has received US Food and Drug Administration 510(k) clearance for its rapid Entamoeba histolytica infection test.
E. histolyticais a protozoan parasite that can cause the intestinal disease amoebiasis. According to Techlab, the parasite is morphologically identical to the non-pathogenic species Entamoeba dispar, making diagnosis of infection difficult.
The Blacksburg, Virginia-based company said that it has now received FDA 510(k) clearance for the E. histolytica Quik Chek, a rapid membrane enzyme immunoassay that detects an adhesin protein unique to the parasite in fecal samples within 30 minutes.