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

描述（申请人提供）：诊断为真实的世界有限公司（DRW）的目标是市场的高性能快速检测B型肝炎病毒（DRW HBsAg快速检测），将在美国和欧洲用作诊断检测，并在发展中国家的血库中用作献血前和献血后筛查检测，特别是那些处理少于10，000例献血，位于HBV高流行地区。这种简单、廉价但高度灵敏的快速检测是由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延续申请，拟对DRW HBsAg快速检测试剂盒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。临床前研究将基于FDA的“体外诊断设备中HBeAg和HBeAg抗体评估的审查标准”。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，该申请获得批准后，将允许DRW HBsAg快速检测试剂盒用于临床研究。旨在向FDA提交PMA的临床研究将在美国的两个研究中心和意大利的一个研究中心进行。由于DRW HBsAg快速检测在资源有限的环境中用于献血前和献血后筛查的有用性，将在印度、中国、几内亚和意大利进行额外的评价。FDA对DRW HBsAg快速检测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