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RANDOX LABORATORIES
Biostrata Ltd on behalf of Thermo
FOCUS DIAGNOSTICS, INC.

Acute Hepatitis B Assay Completes Family of Immunoassay Analyzers

By Labmedica International staff writers
Posted on 02 Aug 2011
Image: the cobas 6000 analyzer series with the cobas e 601 immunoassay module, one of the three analyzers for which the Elecsys Anti-HBc IgM Premarket Approval Application (PMA) was submitted (Photo courtesy of Roche).
Image: the cobas 6000 analyzer series with the cobas e 601 immunoassay module, one of the three analyzers for which the Elecsys Anti-HBc IgM Premarket Approval Application (PMA) was submitted (Photo courtesy of Roche).
A hepatitis B test represents the final component of the acute panel within the hepatitis menu on a family of immunoassay analyzers.

The Elecsys Anti-HBc IgM assay was developed for use on the cobas e 411, cobas e 601, and modular analytics E170 analyzers. The assay is used in 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 acute or recent Hepatitis B virus (HBV) infection.

The Roche (Basel, Switzerland) Elecsys assay will be used with the company's electrochemiluminescence (ECL) immunoassay technology. The company currently has seven other immunoassay tests available on its hepatitis menu: HBsAg, HBsAg Confirmatory, Anti-HBs, Anti-HCV, Anti-HAV, Anti-HAV IgM and Anti-HBc.

Hepatitis B is a contagious liver disease that can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness. It is usually spread by blood, semen, or another body fluid from a person infected with the Hepatitis B virus. The disease can be either acute or chronic. Chronic Hepatitis B virus infection is a long-term serious illness that can result in long-term health problems, and even death.

Roche has submitted the acute hepatitis B test to the US Food and Drug and Administration (FDA; Silver Spring, MD, USA) for premarket approval. The test is not currently available for use in the United States.

Roche is a leader in in-vitro diagnostics, tissue-based cancer diagnostics, and a pioneer in diabetes management.

Related Links:

Roche
US Food and Drug and Administration



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