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.

根据世卫组织对血液安全的统计，全球80%的人口获得了全球20%的 安全的血液供应然而，发展中国家超过40%（13，000，000单位）的血液供应 没有检测三种主要的输血传播感染：人类免疫缺陷病毒（HIV）， B型肝炎病毒（HBV）和丙型肝炎病毒（HCV）。输血不安全血液占8-16万 每年有230万至470万人感染乙型肝炎病毒（HBV）、230万至470万人感染丙型肝炎病毒（HCV）和80，000至160，000人感染艾滋病毒（HIV）。如果不贵， 开发了灵敏度与EIA相当的快速、改进的试纸用于血液筛查， 大大提高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、灵敏的三重（HBV、HIV和HCV）试纸条检测方法 称为三重反射诊断。对于发展中国家，我们建议使用这一检验标准， 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，以确定导致阳性的病原体 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，包括优化试剂和组分，以及开发干格式 系统进行测试。 3.根据药品生产质量管理规范（文件/验证）扩大样品量尺生产规模 用于开发和实地评估试验。 4.最终三重筛选试验的现场评价。