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FDA approves Roche’s hepatitis B test

Monday, October 31, 2011 12:51 PM

Roche has reported that the FDA granted Premarket Approval (PMA) for its IgM antibody to hepatitis B core antigen (Anti-HBc IgM) assay for use on the cobas e 601 analyzer, the immunoassay module of the cobas 6000 analyzer series for mid-volume laboratories. The test represents the final component of the acute panel within the hepatitis test menu for the cobas 6000 series.

The Anti-HBc IgM assay is used for the in-vitro qualitative determination of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma.  The presence of anti-HBc IgM, in conjunction with other laboratory results and clinical information, is indicative of an acute or recent hepatitis B virus (HBV) infection. The assay is 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.

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