HCV dipstick for resource-limited blood banks

描述（由申请人提供）：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）的血液供应没有检测三种主要的输血传播感染：人类免疫缺陷病毒（HIV）、乙型肝炎病毒（HBV）和丙型肝炎病毒（HCV）。每年输血不安全血液导致800万至1600万HBV感染、230万至470万HCV感染和8万至16万HIV感染。如果开发出可与EIA媲美的廉价、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HCV试纸试验，称为HCV反射诊断。在发达国家需要立即得出结果的情况下，可以使用该测试。对于发展中国家，我们建议将该检测纳入三重检测（针对HBV、HIV和HCV），并在高流行国家作为捐献前筛查的第一步。相关的第二步是使用HCV反射诊断试验，以确定导致三联试验阳性结果的因素。

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 HCV dipstick assay designated as the HCV Reflex diagnostic. The test can be used in developed countries under circumstances where an immediate result is required. For the developing countries, we propose that this test be integrated into a Triplex test (for HBV, HIV & HCV) and used as the initial step of pre-donation screening in high prevalence countries. The associated second step is to use the HCV Reflex diagnostic test in order to identify the agent responsible for the positive Triplex test result. The specific aims for phase II are: 1. Further test development including optimization of reagents and components, and developing a dry format system for the test. 2. Scale up of prototype dipstick production under Good Manufacturing Practice (Documentation/Validation) for development and field evaluation trials. 3. Field evaluation of the final HCV Reflex Diagnostic Test for FDA approval.