FDA approves Anti-HBc IgM Assay (Roche) for Hepatitis B testing

The FDA has granted Premarket Approval for the Anti-HBc IgM Assay (IgM antibody to Hepatitis B core antigen Assay), from Roche, for use on its cobas e 601 analyzer, the immunoassay module of the cobas 6000 analyzer series, as a test for Hepatitis B. 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 presence of anti-HBc IgM, which in conjunction with other laboratory results and clinical information, is indicative of an acute or recent hepatitis B virus (HBV) infection. Roche now offers a full selection of hepatitis tests in its immunoassay portfolio: HBsAg, HBsAg Confirmatory, Anti-HBs, Anti-HCV, Anti-HAV, Anti-HAV IgM, Anti-HBc IgM (approved for cobas e 601 analyzer) and Anti-HBc (approved for MODULAR ANALYTICS E170 analyzer). The Anti-HBc IgM assay is also pending FDA approval for use on Roche's cobas e 411 and MODULAR ANALYTICS E170 analyzers.