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(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%(1300万单位)的血液供应没有对三种主要的可经输血传播的感染进行检测：人类免疫缺陷病毒(HIV)、乙肝病毒(乙肝)和丙型肝炎病毒(丙型肝炎病毒)。每年，输血导致800万至1600万人感染乙肝病毒，230万至470万人感染丙型肝炎病毒，8万至16万人感染艾滋病毒。如果开发出廉价、快速、改进的、灵敏度与EIA相当的血液筛查试纸，将极大地改善发展中国家的血液供应安全。该项目的总体目标是开发一种快速和灵敏的三重(针对乙肝病毒、艾滋病毒和丙型肝炎)试纸条检测方法，被指定为三重反射诊断方法。对于发展中国家，我们建议将这项测试作为在高发国家进行捐献前筛查的第一步。相关的第二步是使用艾滋病毒、乙肝病毒和丙型肝炎病毒反射诊断试验，以确定对阳性三联试验结果负有责任的病原体。 第二阶段的具体目标是： 1.将乙肝病毒、丙型肝炎病毒和艾滋病病毒三项检测整合为一项检测-三联检测。 2.进一步的测试开发，包括试剂和成分的优化，以及开发用于测试的干式格式系统。 3.根据用于开发和现场评估试验的良好制造规范(文件/验证)，扩大原型标尺的生产。 4.最终三重筛选试验的现场评估。