Triplex HBV, HCV an HIV dipstick for blood banks

用于血库的 Triplex HBV、HCV 和 HIV 试纸

• 批准号: 7020765
• 负责人: HELEN H LEE
• 金额: $ 44.15万
• 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 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7020765
• 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（申请人提供）：根据世界卫生组织关于血液安全的统计数据，世界80%的人口可以获得世界20%的安全血液供应。然而，发展中国家超过 40%（13,000,000 单位）的血液供应没有经过三种主要输血传播感染的检测：人类免疫缺陷病毒 (HIV)、乙型肝炎病毒 (HBV) 和丙型肝炎病毒 (HCV)。每年，不安全血液输血导致 8-1600 万例 HBV 感染、2.3-470 万例 HCV 感染和 80,000-160,000 例 HIV 感染。如果开发出廉价、快速、改进的、灵敏度可与 EIA 相媲美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 Triplex（用于 HBV、HIV 和 HCV）试纸检测，称为 Triplex Reflex 诊断。对于发展中国家，我们建议将此测试用作高流行国家捐赠前筛查的第一步。相关的第二步是使用 HIV、HBV 和 HCV 反射诊断测试来确定导致 Triplex 测试结果呈阳性的因素。 第二阶段的具体目标是： 1. 将 HBV、HCV 和 HIV 3 项检测整合为一项检测 - Triplex。 2. 进一步的测试开发，包括优化试剂和组分，以及开发用于测试的干格式系统。 3. 根据良好制造规范（文件/验证）扩大原型量油尺生产规模，以进行开发和现场评估试验。 4. 最终三重筛选测试的现场评估。