The US Food and Drug Administration (FDA) has granted clearance to Roche's automated Elecsys HSV-1 IgG and HSV-2 IgG assays, designed for the determination of IgG class antibodies to HSV-1 and HSV-2 in human serum or plasma of sexually active individuals and expectant mothers.
The assays are desgined for use on the company’s cobas e 411, cobas e 601, cobas e 602 and Modular Analytics E170 analyzers.
The company said the immunoassays are intended for use with its electrochemiluminescence technology, a light detection system that provides low-end sensitivity and broad dynamic measuring ranges.
Roche Diagnostics marketing vice president Randy Pritchard said the automated type-specific herpes tests will enable labs to integrate efficient herpes testing into their existing workflow.
"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," Pritchard added.