Acute Hepatitis B Test Granted Premarket Approval

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 electrochemiluminescence (ECL) technology, a highly sensitive light detection system that provides excellent low-end sensitivity and broad dynamic measuring ranges.

The cobas series and anti-HBc IgM assay are products of Roche Diagnostics (Indianapolis, IN, USA). The US Food and Drug Administration (FDA, Silver Springs, MD, USA) granted Premarket Approval (PMA) for the assay. With this approval, 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 combination of full hepatitis menu with the lowest assay duration on the market, the broadest integrated menu, and ECL technology allows the Roche total solution to inspire confidence in the laboratory environment. The Anti-HBc IgM assay is also pending FDA approval for use on Roche's cobas e 411 and MODULAR ANALYTICS E170 analyzers. Roche's current analyzer portfolio offers laboratories short assay duration from nine to 27 minutes, and the broadest test menu available on an integrated platform.

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