FDA advice for HBV (hepatitis B virus) assays producers:
This article was originally published in Clinica
The US FDA has issued draft guidance providing recommendations for manufacturers who make assays to detect the presence of hepatitis B surface antigen in blood, blood components and source plasma donations. The guidance lowers the assay's minimum sensitivity for detecting the virus to 0.50 ng HBsAG/ml from 1.0 ng HBsAG/ml, the threshold used by industry since 1996. The draft was published in the Federal Register on April 11. Comments are due by July 10.
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