美国FDA 指导原则 使用核酸检测降低用于输血的全血和血液成分供体传播西尼罗河病毒的风险 行业指南 英文原版.pdfVIP

Guidance for Industry Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion 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 from the Internet at /BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ default.htm. For questions on the content of this guidance, contact OCOD at the phone numbers listed above. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research November 2009 Contains Nonbinding Recommendations Table of Contents I. INTRODUCTION 1 II. BACKGROUND 1 A. Whole Blood and Blood Components 2 III. RECOMMENDATIONS FOR DONATIONS OF WHOLE BLOOD AND BLOOD COMPONENTS 4 A. Testing, Unit Management, and Donor Management 4 B. Switching from MP-NAT to ID-NAT 5 C. Reporting Test Implementation 6 D. Labeling of Whole Blood and Blood Components Intended for Transfusion . 6 IV. IMPLEMENTATION 9 V. REFERENCES 9 i Contains Nonbinding Recommendations Guidance for Industry Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Bl