FDA thumbs-up completes automated acute hepatitis panel for Bayer:
This article was originally published in Clinica
Executive Summary
Bayer Diagnostics claims it has scored a US first in automated acute hepatitis testing, after gaining FDA clearance to add HBsAg and HBsAg confirmatory assays to the existing six hepatitis tests available on its Advia Centaur immunoassay system. With the clearance, Bayer offers the industry's only complete, FDA-approved automated panel for acute hepatitis testing including assays for HBsAg, HCV, anti-HBc IgM and anti-HAV IgM, said the Tarrytown, New York-based firm. As for other assays on the panel, which can also diagnose and confirm chronic hepatitis B infections, they comprise anti-HBs, anti-HBc total and anti-HAV total.
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