FDA Clearance Announced for Roche’s Automated Herpes Simplex Virus Assays

Roche has announced U.S. Food and Drug Administration (FDA) Clearance 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.

Herpes Simplex Virus Type 1 is mainly transmitted via social contacts during childhood and is generally prevalent in 70-90% of the population. Herpes Simplex Virus Type 2 is usually transmitted sexually and has a prevalence of approximately 17-25% in the general population. HSV Type 1 is most commonly associated with oral herpes, causing infections (sores) of the mouth and lips. HSV Type 2 is primarily associated with genital herpes. Type-specific HSV IgG detection is fundamental to helping healthcare providers manage patients and develop strategies to prevent transmission to partners and babies.

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 are the first automated type-specific herpes tests available for integrated analyzer platforms, which will enable labs to integrate efficient herpes testing into their existing workflow,” said 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.”