Roche has announced that it has received clearance from the U.S. Food and Drug Administration (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.
“These automated type-specific herpes tests are available for integrated analyzer platforms, which will enable labs to integrate efficient herpes testing into their existing workflow,” says Randy Pritchard, vice president of marketing at Roche Diagnostics Corporation. “The approval of the type-specific assays also means healthcare providers now have another tool to give them greater confidence in their diagnosis and overall patient care.”
The addition of these tests further expands the company's infectious disease test portfolio for labs of all sizes. Roche currently offers a broad test menu available on an integrated (chemistry and immunoassay) platform. Read more about Roche solutions for diagnostics.
