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1、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, Outrea
2、ch 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 ocodfda.hhs.gov, or from the Internet at http:/www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida nces/default.htm. F
3、or 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.
4、 INTRODUCTION1 II. DEFINITIONS.2 III. BACKGROUND3 A. Rationale for Donor Screening Using HBV NAT 4 B. Donor Requalification 7 IV. RECOMMENDATIONS.8 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 B
5、asis 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 Intended for Further Manufacture 16 C. Reactive Units and Product Disposition . 17 VI. REPORTING C
6、HANGES TO AN APPROVED APPLICATION.17 A. Test Implementation. 17 B. Labeling . 18 C. Procedures for Requalification of Donors 18 VII. REFERENCES.20 i Contains Nonbinding Recommendations Guidance for Industry Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blo
7、od Components, including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus This guidance represents the Food and Drug Administrations (FDAs) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the publi
8、c. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the appropriate FDA staff. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the
9、 title page of this guidance. I. INTRODUCTION 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-lic
10、ensed 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. In addition, we are notifying
11、you in this guidance that we consider the use of an FDA-licensed HBV NAT to be necessary to reduce adequately and appropriately the risk of transmission of HBV. FDA-licensed HBV NAT can detect evidence of infection at an earlier stage than is possible using previously approved hepatitis B surface an
12、tigen (HBsAg) and antibody to hepatitis B core antigen (anti-HBc) tests. Therefore, we recommend that you use FDA-licensed HBV NAT, in accordance with the requirements under Title 21 Code of Federal Regulations, 610.40(a) and (b) (21 CFR 610.40(a) and (b). This guidance finalizes the draft guidance
13、of the same title dated November 2011. This guidance supplements previous memoranda and guidance from FDA to blood establishments concerning the testing of donations for HBsAg and anti-HBc, and the management of donors and units mentioned in those documents (Refs. 1 through 5). Note that when you im
14、plement HBV NAT testing, you should continue testing for HBsAg and anti-HBc in Whole Blood and blood components intended for transfusion and Source Leukocytes intended for further manufacture, 1 Contains Nonbinding Recommendations 2 and continue testing for HBsAg in Source Plasma.1 FDA may consider
15、advancements in technology for testing blood donations, as well as data obtained following the implementation of HBV NAT, to make future recommendations on adequate and appropriate testing for HBV. FDAs guidance documents, including this guidance, do not establish legally enforceable responsibilitie
16、s. Instead, guidances describe the FDAs current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDAs guidances means that something is suggested or recommended, but not required. II. DEFINITIONS Deconstruction: Resolution of the reactivity of a minipool by testing subpools (original or freshly made) or samples from individual donors that formed the minipool. Deconstruction
