Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus: Final Guidance for Industry

Issue Date: October 1, 2012
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood Products
Status: Final

Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus: Final Guidance for Industry

We, FDA, are providing you, blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes, with recommendations concerning the use of FDA-licensed nucleic acid tests (NAT) to screen blood donors for hepatitis B virus (HBV) deoxyribonucleic acid (DNA). We are also providing you with recommendations for product testing and disposition, donor management, methods for donor requalification, and product labeling.

Download the Guidance Document