DRW HIV-Ab/HCV-Ab/HBsAg Triplex Rapid Test Submission for FDA-PMA Approval

描述（由申请人提供）：机密信息：专利申请过程中。Diagnostics for the真实的World，Ltd.（DRW）旨在销售一种高性能的三重快速检测试剂盒（DRW HIV- Ab/HCV-Ab/HBsAg Triplex Rapid Test; DRW-HTRT），该试剂盒可同时检测人类免疫缺陷病毒（HIV）的抗HIV抗体（HIV-Ab）、丙型肝炎病毒（HCV）的抗HIV抗体和B型肝炎病毒（HBV）的肝炎表面抗原（HBsAg）。该测试将在美国和欧洲用作诊断测试，并在发展中国家的血库中用作献血前和献血后筛查测试，特别是那些每年处理少于10，000次献血并且位于HBV，HCV和HIV高流行地区的血库。这种简单、廉价但高度灵敏的三重快速检测是由DRW在美国国立卫生研究院（NIH）小企业创新研究（SBIR）项目的资助下开发的。该项目是一项竞争性的更新申请，旨在对DRW-HTRT进行临床前和临床研究，最终目的是满足美国食品药品监督管理局（FDA）的上市前批准（PMA）要求。评价HBsAg检测性能的临床前和临床研究将基于FDA的1）“体外诊断器械中HBeAg和HBeAg抗体评估的审查标准”（FDA 1991），用于HBsAg检测的性能评价; 2）“行业指南-B肝炎的充分和适当的供体筛查试验;用于检测全血和血液成分（包括来源血浆和来源白细胞）供体的B型肝炎表面抗原（HBsAg）检测”（FDA 2007）。为了评价HIV抗体检测的检测性能，我们将遵循FDA的指南草案“体外检测抗体的生产和临床评价中的考虑要点”（FDA 1989）。为了评价HCV-Ab检测的检测性能，我们将遵循FDA的指南-行业指南：丙型肝炎病毒（HCV）的“回顾”：产品检疫、收货人通知、进一步检测、产品处置和基于指示HCV感染的供体检测结果的输血受体通知（FDA 2007）。临床前研究的结果将提交给FDA，以获得试验用器械豁免（IDE）申请，一旦获得批准，将允许DRW-HTRT用于临床研究。旨在向FDA提交PMA的临床研究将在美国的四个研究中心和意大利的一个研究中心进行。由于DRW-HTRT在资源有限的环境中用于献血前和献血后筛查的有用性，将在埃及、几内亚和意大利进行额外的评价。FDA对DRW-HTRT的批准不仅为该产品在美国的商业化铺平了道路，而且还将表明一项原则，即发展中国家使用的测试应与发达国家使用的测试具有同样高的质量。机密信息：正在申请专利 公共卫生相关性：机密信息：正在申请专利。DRW HIV-Ab/HCV-Ab/HBsAg三联快速检测试剂盒（DRW-HTRT）的临床研究将使FDA-PMA批准成为可能，因此该检测试剂盒可用于美国市场，在需要快速和即时检测结果的环境中，如急诊室、战场或针刺伤后立即用于医护人员。该测试在发展中国家也将是有用的，在这些国家，确保血液供应的安全需要廉价，有效的检测方法，而不依赖于复杂的设备。在HIV、HCV和HBV病毒标志物高流行地区，每年处理少于10，000例献血的血库尤其如此。机密信息：正在申请专利

DESCRIPTION (provided by applicant): Confidential information: patent application in process. Diagnostics for the Real World, Ltd. (DRW) aims to market a high-performance triplex rapid test (DRW HIV- Ab/HCV-Ab/HBsAg Triplex Rapid Test; DRW-HTRT), which can simultaneously detect for anti-HIV antibodies (HIV-Ab) for human immunodeficiency virus (HIV), anti-HIV antibodies for hepatitis C virus (HCV) and hepatitis surface antigen (HBsAg) for hepatitis B virus (HBV). The test will be useful as a diagnostic test in the United States and Europe, and as a pre- and post-donation screening test in blood banks in developing countries especially those that process less than 10,000 donations per year and are located in regions of high prevalence for HBV, HCV and HIV. This simple and inexpensive but highly sensitive triplex rapid test was developed by DRW with funding from the Small Business Innovation Research (SBIR) program of the National Institutes of Health (NIH). The project is a competing renewal application that proposes to conduct pre-clinical and clinical studies on the DRW-HTRT, with the ultimate aim of meeting the requirements for pre-market approval (PMA) by the Food and Drug Administration (FDA). Pre-clinical and clinical studies to evaluate test performance for HBsAg detection will be based on FDA's 1) "Review criteria for assessment of HBeAg and antibody to HBeAg in vitro diagnostic devices" (FDA 1991) for the performance evaluation on HBsAg detection; 2) "Guidance for Industry-Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes" (FDA 2007). For evaluating the test performance on HIV-Ab detection, we will follow FDA's draft guidance of "Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies" (FDA 1989). For evaluating the test performance on HCV-Ab detection, we will follow FDA's guidance - Guidance for Industry: "Lookback" for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV (FDA 2007). Results of the pre-clinical studies will be presented to the FDA for an Investigational Device Exemption (IDE) application that, when approved, will allow the DRW-HTRT to be used in clinical studies. The clinical studies aimed at a PMA submission to the FDA will be carried out at four sites in the U.S. and one site in Italy. Because of the usefulness of the DRW-HTRT for pre- and post-donation screening in resource-limited settings, additional evaluations will be conducted in Egypt, Guinea and Italy. FDA approval of the DRW-HTRT will not only pave the way for commercialization of the product in the U.S., but will also demonstrate the principle that tests used in developing countries should be of the same high quality as those used in developed countries. Confidential information: patent application in process PUBLIC HEALTH RELEVANCE: Confidential information: patent application in process. Clinical studies of the DRW HIV-Ab/HCV-Ab/HBsAg Triplex Rapid Test (DRW-HTRT) will make FDA-PMA approval possible, and hence availability of the test to the US market, where it will be useful in settings where a rapid and immediate test result is needed, such as emergency rooms, in the battlefield, or for healthcare workers immediately after needle stick injury. The test will also be useful in developing countries where ensuring the safety of the blood supply requires the availability of cheap, effective assays that do not rely on sophisticated equipment. This is especially true in blood banks processing less than10,000 donations/year located in regions of high prevalence for the HIV, HCV and HBV viral markers. Confidential information: patent application in process