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

DRW HIV-Ab/HBsAg 双重快速检测提交 FDA-PMA 批准

• 批准号: 7539876
• 负责人: HELEN H LEE
• 金额: $ 176.3万
• 依托单位: DIAGNOSTICS FOR THE REAL WORLD, LTD
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-16 至 2010-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7539876
• 关键词: Accident and Emergency department; Accounting; Acquired Immunodeficiency Syndrome; Adult; Adverse effects; Affect; Antibodies; Antigens; Biological Assay; Blood; Blood Banks; Blood Screening; Blood Transfusion; Botswana; Caribbean natives; Caribbean region; Centers for Disease Control and Prevention (U.S.); Cessation of life; China; Chronic; Clinic; Clinical Research; Clinical Sensitivity; Complex; Confidential Information; Country; Detection; Developed Countries; Developing Countries; Development; Devices; Diagnosis; Diagnostic; Diagnostic tests; Disease; Donor Selection; Drug resistance; Ensure; Enzyme Immunoassay; Equipment; Europe; European Union; Evaluation; Evaluation Research; Funding; Generic Drugs; Guinea; HIV; Health Personnel; Health Professional; Hepatic; Hepatitis B; Hepatitis B Surface Antigens; Hepatitis B Virus; Hepatitis B e Antigens; Hepatitis C; High Prevalence; Highly Active Antiretroviral Therapy; Human; Human immunodeficiency virus test; Immunologic Deficiency Syndromes; In Vitro; Individual; Industry; Infection; Investigational New Drug Application; Italy; Lateral; Lead; Legal patent; Lesotho; Leukocytes; Life; Liver; Liver diseases; Manufacturer Name; Marketing; Medical Device; Membrane; Mono-S; Needlestick Injuries; Patients; Performance; Pharmaceutical Preparations; Plasma; Pneumococcal Infections; Population; Prevalence; Principal Investigator; Process; Public Health; Rate; Reagent; Reporting; Research; Resources; Risk; Risk Factors; Safety; Sampling; Screening procedure; Signal Transduction; Simian B disease; Site; Small Business Innovation Research Grant; Source; Southern Africa; Standards of Weights and Measures; Swaziland; System; Technology; Test Result; Testing; Time; Transfusion; United States; United States Food and Drug Administration; United States National Institutes of Health; Vaccination; Vaccines; Vascular blood supply; Viral; Viral Load result; Viral Markers; Virus; Virus Diseases; Whole Blood; World Health Organization; Zimbabwe; base; communicable disease diagnosis; design; experience; fighting; flu; improved; killings; neutralizing antibody; pandemic disease; performance tests; pre-clinical; preclinical study; programs; research clinical testing; size; statistics; transmission process

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

描述（申请人提供）：机密信息：专利申请。现实世界中的诊断有限公司（DRW）旨在销售高性能的复式快速测试（DRW HIV-AB/HBSAG复制快速测试），称为DRW HIV-HBV卧dletled，可以同时检测到对HIV（HIV-AB）的抗体（HIV-AB），以诊断人类免疫缺陷率（Hiv-ab），并可以诊断出HEAPFIFICATION INIVINIS（HIV）INTIS（HIV）INTIS（HEP）INTISTIS（HEPATIS）。丙型肝炎病毒（HBV）感染。该测试将在美国和欧洲作为诊断测试，以及在发展中国家的血库前后筛查测试，尤其是那些每年少于10,000捐赠的人，并且位于HBV和/或艾滋病毒的高龄地区。 DRW通过国立卫生研究院（NIH）的小型企业创新研究（SBIR）计划（NIH）开发了这种简单且高度敏感的复式快速测试。该项目是一个相互竞争的续签应用程序，建议对DRW HIV-HBV双工进行临床前和临床研究，其最终目的是满足食品和药物管理局（FDA）的预批准（PMA）要求。评估HBSAG检测测试性能的临床前研究将基于FDA的1）“评估HBEAG和HBEAG在体外诊断设备上的评估标准”（FDA 1991），以评估HBSAG检测的性能评估；和2）“用于乙型肝炎的行业和适当的供体筛查测试的指导；乙型肝炎表面抗原（HBSAG）测定法，用于测试全血和血液成分的供体，包括来源血浆和源白细胞 - 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“在制造和临床评估中要考虑以检测抗体的生产和临床评估”（FDA 1989）。临床前研究的结果将向FDA提出，以进行研究设备豁免（IDE）应用，该应用将批准，该应用将允许DRW HIV-HBV复合体的开发继续进行临床研究。针对PMA提交FDA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双链体在资源有限的环境中进行筛查的有用性，将在中国和几内亚进行其他评估。 FDA批准了DRW HIV-HBV双链体将允许在美国使用新的且有用的诊断测试，但也将证明在发展中国家使用的测试应与发达国家使用的测试相同。机密信息：流程专利申请主要研究人员：Lee，Helen H机密信息：专利在公共卫生相关性中的专利申请：DRW HIV HIV HIV-HBV双工快速测试的临床研究将使FDA的批准成为可能，因此可以对美国市场进行测试，并在需要立即进行紧急情况下进行检查，或者需要立即进行急诊室，或者需要进行急诊室，或者需要进行临时效果。该测试在发展中国家还将很有用，在发展中国家确保血液供应的安全需要廉价，有效的测定法，这些测定法不依赖精致的设备。在艾滋病毒和HBV病毒标志物高流行率的地区，少于10,000个捐款/年处理的血库尤其如此。机密信息：专利申请