Roche Cleared for Herpes Simplex Virus Type 1 and 2 Tests
Roche announced that it has received clearance from the FDA for its IgG Antibody to herpes simplex virus (HSV) types 1 and 2 assays for use on 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.
For more information call (800) 526-6367 or visit www.roche.com.