Roche Receives FDA Approval for Acute Hepatitis B Test
With this approval, Roche now offers a full selection of hepatitis tests in its immunoassay portfolio.
Basel-based healthcare company Roche announced Monday that the U.S. 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
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