HCV dipstick for resource-limited blood banks

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而灵敏的丙型肝炎病毒试纸检测方法，被指定为丙型肝炎病毒反射诊断。该检测可在发达国家需要立即结果的情况下使用。对于发展中国家，我们建议将这一检测纳入三重检测(针对乙肝病毒、艾滋病毒和丙型肝炎病毒)，并作为高流行国家捐献前筛查的初始步骤。相关的第二步是使用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责的试剂。 第二阶段的具体目标是： 1.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。 2.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。 3.FDA批准的最终丙型肝炎病毒反射诊断试验的现场评估。

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.