Preclinical and clinical studies of an HBV rapid test for FDA Pre-market approval

描述(由申请人提供)：真实世界诊断有限公司(DRW)旨在营销一种高性能的乙肝病毒快速检测(DRW乙肝表面抗原快速检测)，该检测将在美国和欧洲用作诊断测试，并在发展中国家的血库中作为捐献前和捐献后的筛查测试，特别是那些每年处理不到10,000次捐献和位于乙肝病毒高发区的血库。这种简单、廉价但高度敏感的快速测试是由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延续申请，建议对DRW乙肝表面抗原快速检测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。临床前研究将基于FDA的“评估HBeAg和HBeAg抗体体外诊断设备的审查标准”。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乙肝表面抗原快速检测用于临床研究。这项旨在向FDA提交PMA的临床研究将在美国的两个地点和意大利的一个地点进行。由于DRW乙肝表面抗原快速检测在资源有限的情况下用于捐献前和捐献后筛查，将在印度、中国、几内亚和意大利进行额外的评估。FDA批准DRW乙肝表面抗原快速检测不仅将为该产品在美国的商业化铺平道路，还将证明在发展中国家使用的检测应该与发达国家使用的检测具有同样高质量的原则

DESCRIPTION (provided by applicant): Diagnostics for the Real World, Ltd. (DRW) aims to market a high-performance rapid test for hepatitis B virus (DRW HBsAg Rapid Test) that 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. This simple and inexpensive but highly sensitive 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 continuation application that proposes to conduct pre-clinical and clinical studies on the DRW HBsAg rapid test, with the ultimate aim of meeting the requirements for pre-market approval (PMA) by the Food and Drug Administration (FDA). The pre-clinical studies will be based on FDA's "Review criteria for assessment of HBeAg and antibody to HBeAg in vitro diagnostic devices". 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 HBsAg Rapid Test to be used in clinical studies. The clinical studies aimed at a PMA submission to the FDA will be carried out at two sites in the U.S. and one site in Italy. Because of the usefulness of the DRW HBsAg rapid test for pre- and post-donation screening in resource-limited settings, additional evaluations will be conducted in India, China, Guinea and Italy. FDA approval of the DRW HBsAg Rapid Test 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