Triplex HBV, HCV an HIV dipstick for blood banks

用于血库的 Triplex HBV、HCV 和 HIV 试纸

• 批准号: 7474866
• 负责人: HELEN H LEE
• 金额: $ 57.57万
• 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 2008-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7474866
• 关键词: Accounting; Antibodies; Antigens; Biological Assay; Blood; Blood Banks; Blood Screening; Blood Transfusion; Blood donor; Collection; Complement; Confidentiality; Country; Detection; Developed Countries; Developing Countries; Development; Diagnostic; Diagnostic tests; Discrimination; Evaluation; Funding; Goals; HIV; Hepatitis; Hepatitis B Virus; Hepatitis C; Hepatitis C virus; High Prevalence; Hospitals; Individual; Infection; Laboratories; Microbiology; Patients; Phase; Population; Primary Health Care; Production; Reagent; Reflex action; Reporting; Resources; Risk; Safety; Screening procedure; Signal Transduction; Simian B disease; Site; Small Business Funding Mechanisms; Small Business Innovation Research Grant; System; Test Result; Testing; Transfusion; Transfusion-Transmitted Virus; Validation; Vascular blood supply; Viral; Viral Markers; Virus; Virus Diseases; Visual; World Health Organization; improved; prototype; scale up; statistics; tool; virology

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.

根据世卫组织关于血液安全的统计数据，80%的世界人口可以接触到世界上20%的 安全的血液供应。然而，发展中国家超过40%(1300万单位)的血液供应 没有检测出三种主要的可通过输血传播的感染：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)。输注不安全血液占800万至1600万 乙肝病毒感染，每年230万-470万丙型肝炎病毒感染和8万-16万艾滋病毒感染。如果价格不贵， 用于血液筛查的快速、改进的试纸的灵敏度与EIA相当，它将 大大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病毒)试纸条检测方法。 被指定为三面反射诊断程序。对于发展中国家，我们建议使用这一测试。 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负有责任的病原体 三重测试结果。 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，以及开发干格式 用于测试的系统。 3.在良好的制造规范(文件/验证)下扩大样机量具生产 用于开发和实地评估试验。 4.最终三重筛选试验的现场评估。