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September 5, 2012

FDA Sanctions Roche’s HSV IgG Assays

  • FDA approved Roche’s Elecsys (HSV) types 1 and 2 IgG assays for use on the cobas™ platform. The assays are for use with sexually active individuals and pregnant women as an aid to the presumptive diagnosis of HSV1 or 2 infection. Roche says the HSV tests are the first automated assays available for integrated analyzer platforms, “which will enable labs to integrate efficient herpes testing into their existing workflow,” comments Randy Pritchard, vp of marketing at Roche Diagnostics.

    “The Elecsys HSV-2 IgG and HSV-3 IgG assays provide qualitititve determination of IgG antibodies in serum or plasma. The tests are used wtih Roche’s electrochemiluminescence technology, and are approved for use on a range of systems, including the Elecsys 2010, cobas e 411, cobas e 601, cobas e 602, and Modular Analytics E170 analyzers.

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