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Home » FDA to Tighten Sensitivity Requirements for HBsAg Assays
FDA to Tighten Sensitivity Requirements for HBsAg Assays
August 17, 2007
In a new guidance document, the FDA announced that hepatitis B surface antigen (HBsAg) assays, used to detect the presence of hepatitis B infection in donations of human blood and blood components, should have a capability of detecting at least 0.5ng HBsAg/mL.