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
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.
US Food and Drug and Administration