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FDA approves Abbott's HBV molecular diagnostic for measuring viral load
Thursday, September 02 2010 | Comments
What's This?
The Food and Drug Administration approved Abbott's RealTime HBV (hepatitis B virus) assay, a PCR (polymerase chain reaction)-based test that is the first molecular assay approved for automating HBV viral load testing from sample extraction to final results, according to the Abbott.The HBV assay is designed for use on Abbott's m2000 automated instrument system for molecular diagnostic testing using samples from patient sera or plasma. The test is to be used on individuals who are chronically infected with HBV and are undergoing antiviral therapy. It can be used during treatment to help assess response to treatment; it is not, however, approved for use in determining the clinical stage of HBV infection.
The test is able to detect HBV genotypes A to H and can quantitate a broad range of virus levels, from 10 IU/mL to 1 billion IU/mL, Abbott noted.
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