HBV NAT检测指南(FDA).pdfVIP

Guidance for Industry 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 Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD), (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852- 1448, or by calling 1-800-835-4709 or 301-827-1800, or e-mail ocod@, or from the Internet at /BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida nces/default.htm. For questions on the content of this guidance, contact OCOD at the phone numbers or e-mail address listed above. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research October 2012 Contains Nonbinding Recommendations Table of Contents I. INTRODUCTION1 II. DEFINITIONS 2 III. BACKGROUND 3 A. Rationale for Donor Screening Using HBV NAT 4 B. Donor Requalification 7 IV. RECOMMENDATIONS8 A. Donor Screening Using HBV NAT 8 B. Management of Donors and Units Based on Hepatitis B Test Results 10 C. Requalification Methods for Donors on the Basis of HBV NAT and HBV Serologic Test Results on the Follow-Up Sample 13 V. LABELING 16 A. Circular of Information for Whole Blood and Blood Components Intended for Transfusion 16 B. Blood Components In