美国FDA 指导原则 使用来自人体细胞、组织以及细胞和组织产品(HCTPS)供体的身体血液标本获得传染病供体筛查测试标签声明的建议 行业指南 英文原版.pdfVIP

Guidance for Industry Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(4)(i). Submit comments on this guidance at any time to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. Additional copies of this guidance are available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or 301-827-1800, or from the Internet at /cber/guidelines.htm. For questions on the content of this guidance, contact Melissa Greenwald, M.D., at 301-827- 2002. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research November 2004 Contains Nonbinding Recommendations Table of Contents I. INTRODUCTION 1 II. BACKGROUND 2 III. DISCUSSION 3 A. What data about specificity and sensitivity are recommended when matched pairs of pre- and post-mortem serum/plasma specimens are available? 3 1. Specificity 3 a. Clinical Specificity 3 b. Analytical Specificity 3 2. Sensitivity 3 a. Clini