HBV dipstick for resource-limited blood banks

描述（由申请人提供）：根据世卫组织关于血液安全的统计数据，世界上80%的人口可获得世界上20%的安全血液供应。然而，发展中国家超过40%（13，000，000单位）的血液供应没有进行三种主要输血传播感染的检测：人类免疫缺陷病毒（HIV），B肝炎病毒（HBV）和丙型肝炎病毒（HCV）。不安全血液的输入每年造成800 - 1600万乙型肝炎病毒感染、230 - 470万丙型肝炎病毒感染和80 000 - 160 000艾滋病毒感染。如果开发出灵敏度与EIA相当的廉价、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HBsAg（HBV）试纸检测法，称为HBV反射诊断法。在发达国家，在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，我们建议将该测试整合到三重测试（HBV，HIV和HCV）中，并用作高流行率国家献血前筛查的第一步。相关的第二步是使用HBsAg反射诊断测试，以确定代理负责阳性三重测试结果。第二阶段的具体目标是：1.进一步的测试开发，包括试剂和组件的优化，以及开发用于测试的干格式系统。2.根据药品生产质量管理规范（文件编制/验证）扩大样品试纸的生产规模，以进行开发和现场评价试验。3. FDA批准的最终HBsAg反射诊断测试的现场评估。

DESCRIPTION (provided by applicant): According to WHO statistics on blood safety, 80 percent of the world's population has access to 20 percent of the world's safe blood supply. However, more than 40 percent (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 HBsAg (HBV) dipstick assay designated as the HBV 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 and HCV) and used as the initial step of pre-donation screening in high prevalence countries. The associated second step is to use the HBsAg 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 HBsAg Reflex Diagnostic Test for FDA approval.