Guidance on Hepatitis B Tests for HCT/P Donors

    Federal Register Notice: FDA is making available a draft document entitled   Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry. It provides establishments that make donor eligibility determinations for donors of human cells, tissues, and tissue-based products (HCT/Ps), with recommendations concerning the use of FDA-licensed nucleic acid tests in donor testing for hepatitis B virus deoxyribonucleic acid. When finalized, it is intended to supplement previous FDA recommendations to HCT/P establishments concerning donor testing for hepatitis B surface antigen and total antibody to hepatitis B core antigen, in the document entitled Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) dated 8/2007. To download this draft guidance, click here. To view this notice, click here.