Development and Commercialization of an Innovative Rapid HIV-1 Incidence Assay

描述(由申请人提供)：该项目的目标是开发一种商业上可行的HIV-1感染快速检测方法，并确定其是否适合用于流行病学、研究和监测目的的全血、血浆、血清样本中HIV-1感染的新近性的确定。进一步确定该检测方法应用于干血斑和口腔液标本的可行性。潜力 在项目第二阶段之前，不打算将该检测开发为包括适用的监管提交的发病率/诊断综合检测。用于区分近期和长期艾滋病毒感染的准确分析方法的最新进展仅限于基于实验室的复杂分析。然而，许多资源有限的国家和实验室需要能够估计人口中的艾滋病毒发病率，但不能随时获得完整的实验室设施。拟议的HIV-1感染快速检测一旦被确定为适用于人口监测用途，最终也可能有助于在与诊断一致的情况下，在护理地点为个人提供量身定制的治疗、咨询和接触跟踪。该检测将基于SEDIA生物科学公司专有的快速横向流动免疫层析测试技术和从美国疾病控制中心(CDC)开发并获得许可的快速发病率测试技术的组合进行开发。该项目与美国疾病控制与预防中心密切相关，因为美国疾病控制与预防中心负责监督多个国内和国际项目，以监测美国和世界各地的艾滋病毒流行情况，包括实验室资源有限的国家。研究人员、流行病学家、其他政府和私人公共卫生组织以及疫苗试验项目经理也可以使用拟议的分析方法来了解和瞄准艾滋病毒流行，以及评估干预计划的有效性和确定感染的“热点”。SEDIA打算在这个项目上与疾控中心艾滋病毒项目的国内和国际分支机构合作，根据疾控中心的需求和规范开发化验方法，并与疾控中心合作使用已知的新近存档的横断面血清样本来评估结果，以确定测试的准确性。SEDIA还打算通过CEPHIA(艾滋病毒发病率分析性能评估联合会)计划引导分析原型，以评估艾滋病毒发病率分析，然后在项目第二阶段将测试扩大到多个外部调查人员。

DESCRIPTION (provided by applicant): The objective of this project is to develop a commercially viable point of care Rapid HIV-1 Incidence Assay and establish its suitability for determination of recency of HIV-1 infection in whole blood, plasma, serum specimens for epidemiological, research and surveillance purposes. It is further intended to determine the feasibility of the application of the assay to dried blood spot and oral fluid specimens. Potential development of the assay into a combined incidence/diagnostic assay including applicable regulatory submissions is not intended until Phase II of the project. Recent advances in development of accurate assays for distinguishing recent from long-term HIV infections have been limited to complex laboratory based assays. However, many resource constrained countries and laboratories need to be able to estimate HIV incidence rates in populations, but do not have ready access to full laboratory facilities. The proposed Rapid HIV-1 Incidence Assay, once established as suitable for population surveillance use, may also eventually be useful for providing tailored therapeutic, counseling and contact follow-up of individuals at the point of care, coincident with diagnosis. The assay will be developed based on a combination of rapid lateral flow immunochromatography test technology proprietary to Sedia Biosciences and rapid incidence test technology developed and licensed from the U.S. Centers for Disease Control (CDC). The project is of significant relevance to the CDC, as the CDC oversees a number of domestic and international programs to monitor the HIV epidemic in the U.S. and around the world, including in countries that have limited laboratory resources. The proposed assay may be used as well by researchers, epidemiologists, other governmental and private public health organizations and vaccine trial program managers to understand and target the HIV epidemic, as well as assess the effectiveness of intervention programs and identify "hot spots" of infections. Sedia intends to collaborate with the domestic and international branches of the CDC's HIV program on this project by developing the assay according to CDC needs and specifications, and evaluate the resulting assay in cooperation with the CDC using archived cross-sectional serum specimens of known recency to determine the accuracy of the test. Sedia further intends to channel assay prototypes through the CEPHIA (Consortium for the Evaluation of Performance of HIV Incidence Assays) program to evaluate HIV incidence assays, before expanding testing to multiple outside investigators in Phase II of the project.