FDA approves Elecsys HSV Assays (Roche) for detecting Herpes Simplex virus

The FDA has cleared the Elecsys HSV-1 IgG and HSV-2 IgG assays, from Roche, for detecting Herpes Simplex virus (HSV) types 1 and 2. The assays are for use on Roche's cobas modular platforms. The tests are intended for use with sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 and HSV-2 infection. The Elecsys HSV-1 IgG and HSV-2 IgG assays are for the in-vitro qualitative determination of IgG class antibodies to HSV-1 and HSV-2 in human serum or plasma. The immunoassays are intended for use with Roche's electrochemiluminescence (ECL) technology, a highly sensitive light detection system that provides excellent low-end sensitivity and broad dynamic measuring ranges. The tests are approved for use on the Elecsys 2010, cobas e 411, cobas e 601, cobas e 602 and Modular Analytics E170 analyzers.