Triplex HBV, HCV an HIV dipstick for blood banks

用于血库的 Triplex HBV、HCV 和 HIV 试纸

• 批准号: 6882571
• 负责人: HELEN H LEE
• 金额: $ 40.25万
• 依托单位: DIAGNOSTICS FOR THE REAL WORLD, LTD
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-01-05 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6882571
• 关键词: bioassay; blood bank /supply contamination; blood banks; blood tests; clinical chemistry; clinical research; clinical trials; diagnosis design /evaluation; diagnosis quality /standard; field study; hepatitis B virus group; hepatitis C virus; human immunodeficiency virus; human subject; international cooperation; rapid diagnosis; reagent /indicator; serotyping

DESCRIPTION (provided by applicant): According to WHO statistics on blood safety, 80% of the world's population has access to 20% of the world's safe blood supply. However, more than 40% (13,000,000 units) of the blood supply in the developing world is not tested for the three major transfusion-transmissible infections: human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV). Transfusion of unsafe blood accounts for 8-16 million HBV infections, 2.3-4.7 million HCV infections and 80,000-160,000 HIV infections each year. If inexpensive, rapid, improved dipsticks with sensitivity comparable to EIA were developed for blood screening, it would greatly improve the safety of the blood supply in developing countries. The overall aim of the project is to develop a rapid and sensitive Triplex (for HBV, HIV & HCV) dipstick assay designated as the Triplex Reflex diagnostic. For the developing countries, we propose that this test be used as the initial step of pre-donation screening in high prevalence countries. The associated second step is to use the HIV, HBV and HCV Reflex diagnostic tests in order to identify the agent responsible for the positive Triplex test result. The specific aims for phase II are: 1. Integrate 3 tests HBV, HCV and HIV into one test - Triplex. 2. Further test development including optimization of reagents and components, and developing a dry format system for the test. 3. Scale up of prototype dipstick production under Good Manufacturing Practice (Documentation/Validation) for development and field evaluation trials. 4. Field evaluation of the final Triplex screening Test.

描述（由申请人提供）：根据世卫组织关于血液安全的统计数据，世界上80%的人口可获得世界上20%的安全血液供应。然而，发展中国家超过40%（13，000，000单位）的血液供应没有进行三种主要输血传播感染的检测：人类免疫缺陷病毒（HIV），B肝炎病毒（HBV）和丙型肝炎病毒（HCV）。不安全血液的输入每年造成800 - 1600万乙型肝炎病毒感染、230 - 470万丙型肝炎病毒感染和80 000 - 160 000艾滋病毒感染。如果开发出灵敏度与EIA相当的廉价、快速、改进的试纸用于血液筛查，将大大提高发展中国家血液供应的安全性。该项目的总体目标是开发一种快速、灵敏的三重（HBV、HIV和HCV）试纸检测，称为三重反射诊断。对于发展中国家，我们建议将此测试作为高流行率国家献血前筛查的第一步。相关的第二步是使用HIV，HBV和HCV反射诊断测试，以确定代理负责阳性三重测试结果。 第二阶段的具体目标是： 1.将3种检测HBV、HCV和HIV整合到一种检测中- Triplex。 2.进一步的测试开发，包括试剂和组件的优化，以及开发用于测试的干格式系统。 3.根据药品生产质量管理规范（文件编制/验证）扩大样品试纸的生产规模，以进行开发和现场评价试验。 4.最终三重筛选试验的现场评价。