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

描述（由申请人提供）：保密信息：正在申请专利。诊断为真实世界，有限公司（DRW）的目标是市场上的高性能三重快速测试（DRW HIV-Ab /HCV-Ab/HBsAg三重快速测试；DRW- htrt），它可以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抗体和乙型肝炎病毒（HBV）的肝炎表面抗原（HBsAg）。该检测方法在美国和欧洲可作为一种诊断检测方法，在发展中国家的血库中可作为捐献前和捐献后的筛查检测方法，特别是在那些每年捐献量少于1万次并且位于HBV、HCV和HIV高流行地区的国家。这种简单、廉价但高度敏感的三重快速检测是由DRW在美国国立卫生研究院（NIH）的小企业创新研究（SBIR）项目的资助下开发的。该项目是一项竞争性续期申请，提议对DRW-HTRT进行临床前和临床研究，最终目的是满足美国食品和药物管理局（FDA）上市前批准（PMA）的要求。评估HBsAg检测性能的临床前和临床研究将基于FDA的“HBeAg和HBeAg抗体体外诊断设备评估审查标准”（FDA 1991），用于评估HBsAg检测的性能；2)《行业指南——充分和适当的乙型肝炎供体筛查试验；乙型肝炎表面抗原（HBsAg）测定用于检测供者的全血和血液成分，包括来源血浆和来源白细胞”（FDA 2007）。为了评估HIV-Ab检测的测试性能，我们将遵循FDA的指导草案“在检测抗体的体外测试的制造和临床评估中要考虑的要点”（FDA 1989）。为了评估HCV- ab检测的测试性能，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，以及基于供体检测结果提示HCV感染的输血受者通知（FDA 2007）。临床前研究的结果将提交给FDA进行研究器械豁免（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地点和意大利的一个地点进行。由于DRW-HTRT在资源有限的情况下对捐献前和捐献后筛查的有用性，将在埃及、几内亚和意大利进行更多的评估。FDA批准DRW-HTRT不仅将为该产品在美国的商业化铺平道路，而且还将证明在发展中国家使用的测试应该与发达国家使用的测试具有相同的高质量原则。保密信息：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