DRW HIV-Ab/HBsAg Duplex Rapid Test submission for FDA-PMA approval

描述(申请人提供)：机密信息：专利申请正在进行中。真实世界诊断有限公司(DRW)的目标是推出一种高性能的双重快速测试(DRW HIV-Ab/HBs Ag Duplex Rapid Test)，称为DRW HIV-HBVDuplex，它可以同时检测用于诊断人类免疫缺陷病毒(HIV)感染的HIV抗体和用于诊断乙肝病毒(HBV)感染的乙肝表面抗原(HBs)。该检测将在美国和欧洲作为一种诊断测试，并在发展中国家的血库中作为献血前和献血后的筛查测试，特别是那些每年处理不到10,000次献血并位于乙肝和/或艾滋病毒高发区的国家。这种简单、廉价但高度灵敏的双重快速检测是由DRW在美国国立卫生研究院(NIH)小型企业创新研究(SBIR)计划的资助下开发的。该项目是一个竞争性的续签申请，建议对DRW HIV-HBVDuplex进行临床前和临床研究，最终目的是满足食品和药物管理局(FDA)上市前批准(PMA)的要求。评估乙肝表面抗原检测检测性能的临床前研究将基于FDA的1)“关于体外检测HBeAg及HBeAg抗体的审查标准”(FDA 1991)，用于对乙肝表面抗原检测的性能进行评估；和2)“行业适当和适当的献血者筛选试验指南；用于检测献血者包括来源血浆和来源白细胞的全血和血液成分的乙肝表面抗原检测方法”(FDA 2007)。为了评估HIV-Ab检测的测试性能，我们将遵循FDA的指南草案“抗体体外检测测试的制作和临床评估中应考虑的要点”(FDA 1989)。临床前研究的结果将提交给FDA的研究设备豁免(IDE)申请，一旦获得批准，将允许DRW HIV-HBVDuplex的开发进入临床研究。这项旨在向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艾滋病毒-乙肝双重筛查在资源有限的情况下用于捐献前和捐献后筛查，将在中国和几内亚进行额外的评估。FDA批准DRW HIV-HBVDuplex将允许在美国使用一种新的有用的诊断测试，但也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同样高质量的原则。机密信息：专利申请正在进行中首席调查员：Lee，Helen H机密信息：专利申请正在进行与公共卫生相关：DRW HIV-HBV二次快速检测的临床研究将使FDA批准该检测，从而使该检测进入美国市场，在需要快速和即时检测结果的环境中，如急诊室、战场上，或针头刺伤后立即对医护人员来说，它将很有用。这项检测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、不依赖尖端设备的检测。在位于艾滋病毒和乙肝病毒标志物高发区的血库中，每年处理不到10,000份献血的情况尤其如此。机密信息：专利申请正在进行中

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