Zdrowie i gospodarka · 08/08/2007

Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes; Availability

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes" dated July 2007. The guidance document provides recommendations to manufacturers of HBsAg assays that are intended to test donors of Whole Blood and blood components, including Source Plasma and Source Leukocytes, and to establishments using an HBsAg assay. Topics include recommendations on minimum sensitivity standards for HBsAg assays. This guidance finalizes the draft guidance entitled "Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components, and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.