Triplex HIV, HCV and HBV dipstick

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，超过20%（13，000，000单位）的世界血液供应没有检测三种主要的输血传播感染：HIV，HBV和HCV。输血或注射不安全血液造成每年800 - 1600万例B型肝炎病毒感染、230 - 470万例丙型肝炎病毒感染和80，000 - 160，000例HIV感染。这个问题在资源贫乏的国家尤其严重，这些国家显然需要增加安全血液的供应。 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。此外，能够同时检测低水平的HBsAg或HIV或HCV抗体的三重测试形式将为资源有限环境中的血库提供以适合于当地环境和资源的形式筛选所有三种主要或病毒标志物的手段。 本I期工作的目的是开发一种工作双链体试纸，作为II期计划的三链体检测形式的原理证明。因此，在I期结束时，工作双链体试纸将证明可以使用一个试纸从单个样本中同时检测到HBsAg和抗HIV p24抗体。 我们建议，这种双重测试，然后可以扩展到三重测试，并作为血液筛查的第一步，在资源匮乏，高流行率的国家。相关的第二步是使用专门检测HBsAg或HIV或HCV（Reflex）的测试，以确定负责初始测试结果的试剂。

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 20 percent (13,000,000 units) of the world blood supply is not tested for the three major transfusion transmissible infections: HIV, HBV and HCV. Transfusion or injection of unsafe blood accounts for 8-16 million hepatitis B virus infections, 2.3-4.7 million hepatitis C virus infections, and 80,000-1 60,000 HIV infections each year. The problem is especially severe in resource-poor countries where the availability of safe blood clearly needs to be increased. 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. In addition, a Triplex test format capable of detecting simultaneously low levels of HBsAg or antibodies to HIV or HCV would provide blood banks in resource-limited settings with the means for screening all three ma]or viral markers in a format adapted to local settings and resources. The aim of this Phase I work is to develop a working duplex dipstick as proof of principle for the Triplex assay format planned for Phase II. Thus at the end of Phase I, the working duplex dipstick will have demonstrated that HbsAg and anti-HIV p24 antibodies can be simultaneously detected from a single sample using one dipstick. We propose that this duplex test could then be expanded into a Triplex test and used as the initial step of blood screening in resource-poor, high prevalence countries. The associated second step is to use a test detecting specifically HBsAg or HIV or HCV (Reflex) to identify the agent responsible for the initial test result.