Zdrowie i gospodarka · 11/04/2002

Draft “Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components, and Source Plasma Donations;” Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HbsAg) Assays Used to Test Blood, Blood Components, and Source Plasma Donations," dated April 2002. The draft guidance document when finalized is intended to provide recommendations to manufacturers of assays for the detection of HBsAg that are intended to be used to test blood, blood components, and Source Plasma. Topics include recommendations on minimum sensitivity specifications for HbsAg assays used to test blood, blood components, and Source Plasma donations.