Triplex HIV, HCV and HBV dipstick

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，世界上80%的人口可以获得世界上20%的安全血液供应。然而，超过20%（1300万单位）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每年造成800万至1600万例乙型肝炎病毒感染、230万至470万例丙型肝炎病毒感染和8万至16万例艾滋病毒感染。这一问题在资源贫乏的国家尤为严重，这些国家显然需要增加安全血液的供应。

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.