DRW HIV-Ab/HBsAg Duplex 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。Diagnostics for the Real World, Ltd. （DRW）旨在推出一种高性能双工快速检测（DRW HIV- ab /HBsAg双工快速检测），称为DRW HIV-HBV双工，可以同时检测用于诊断人类免疫缺陷病毒（HIV）感染的HIV抗体（HIV- ab）和用于诊断乙型肝炎病毒（HBV）感染的乙型肝炎表面抗原（HBsAg）。这种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和/或HIV高流行地区的国家。这种简单、廉价但高灵敏度的双相快速测试是由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 HIV-HBV双工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）来评估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）。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 HIV-HBV Duplex的开发进入临床研究。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 HIV-HBV双工在资源有限的环境中用于捐献前和捐献后筛查的有效性，将在中国和几内亚进行额外的评估。FDA批准DRW HIV-HBV双工将允许在美国使用一种新的有用的诊断测试，但也将证明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：正在进行的专利申请主要研究者：Lee， Helen H保密信息：正在进行的专利申请公共卫生相关性：DRW HIV-HBV双工快速检测的临床研究将使FDA批准成为可能，从而使该检测进入美国市场，它将在需要快速和即时检测结果的环境中发挥作用，例如急诊室，战场上，或在针刺伤后立即为医护人员提供检测结果。这种检测方法在发展中国家也很有用，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。在艾滋病毒和乙型肝炎病毒标记物高流行地区，每年处理少于1万次献血量的血库尤其如此。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 duplex rapid test (DRW HIV-Ab/HBsAg Duplex Rapid Test), called DRW HIV-HBV Duplex, which can simultaneously detect antibodies to HIV (HIV-Ab) for diagnosis of human immunodeficiency virus (HIV) infection and hepatitis B surface antigen (HBsAg) for diagnosis of hepatitis B virus (HBV) infection. 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 and/or HIV. This simple and inexpensive but highly sensitive duplex 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 HIV-HBV Duplex with the ultimate aim of meeting the requirements for pre- market approval (PMA) by the Food and Drug Administration (FDA). Pre-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; and 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). 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 development of DRW HIV-HBV Duplex to proceed to 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 HIV-HBV Duplex for pre- and post-donation screening in resource-limited settings, additional evaluations will be conducted in China and Guinea. FDA approval of the DRW HIV-HBV Duplex will allow the use of a new and useful diagnostic test 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 Principal Investigator: Lee, Helen H Confidential information: patent application in process PUBLIC HEALTH RELEVANCE: Clinical studies of the DRW HIV-HBV Duplex Rapid Test will make FDA 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 and HBV viral markers. Confidential information: patent application in process