Automated Hep B Test Approved
The ARCHITECT CORE-M, an automated Hepatitis B assay manufactured by Abbott Diagnostics, has been approved by the FDA as detailed in a press release from the company.
The new test is designed for use with the Abbott ARCHITECT instrument. The new test detects the presence of immunoglobulin (IgM) antibodies to hepatitis B core antigen virus. Four different assays are included in this test: HAVAB-M, HBsAg, CORE-M, and Anti-HCV.
The test can be used in combination with others to evaluate patients for the presence of acute hepatitis. It can also help clinicians determine if patients have recently had the viral infection.
The ARCHITECT hepatitis assays available from Abbott include the ARCHITECT AUSAB. This test is used to evaluate patients’ immune response to vaccination for hepatitis B and susceptibility to the virus itself. Also available is the ARCHITECT HBsAg Confirmatory, this test confirms that patients do have the hepatitis B surface antigen.
Viral hepatitis is one of the more common communicable illness in the U.S. that is reportable. The condition, which cause liver inflammation, is caused by a number of different agents including bacteria, toxins, excessive alcohol use, and drugs.
December 21, 2007 Related topics: Laboratory, Product Approval & Certification, Diagnostic