Novel Single Well Avidity EIA to Determine Recency of HIV-1 Infections

描述(申请人提供)：该项目的目标是开发一种商业上可行的HIV-1限制性抗原亲和力EIA，并确定其是否适合于确定HIV-1感染的近期情况。区分近期和长期艾滋病毒感染的准确工具对于确定人群中的艾滋病毒发病率是重要的，也可能有助于为个人提供量身定制的治疗、咨询和接触后续行动。该检测将基于美国疾病控制中心(CDC)开发和许可的技术进行开发。在完成疾病预防控制中心的技术转让后，SEDIA将采用专有技术开发一种强大、稳定、用户友好的检测方法。该项目与疾控中心密切相关，因为疾控中心目前管理着一个全国性的艾滋病毒/艾滋病监测系统，该系统是美国用于跟踪疫情的及时信息的来源。疾控中心使用该系统中的艾滋病毒近期数据来估计艾滋病毒发病率并跟踪疫情，并正在寻求通过使用更好的分析方法来获得更准确的数据，例如HIV-1限制抗原亲和力EIA。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该分析来了解疫情并确定目标，以及评估干预计划的有效性。SEDIA打算在这个项目上与疾控中心合作，根据疾控中心的需求和规格开发化验，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，然后在项目第二阶段将测试扩大到多个外部投资者。 公共卫生相关性：该项目是为了开发一种商业上可行的HIV-1限制抗原亲和性EIA，并确定其是否适合于确定HIV-1感染的近期情况。疾控中心使用艾滋病毒最近的数据来估计艾滋病毒发病率并跟踪疫情，并正在寻求通过使用更好的分析方法获得更准确的数据，例如艾滋病毒-1限制抗原Avidity EIA。这项测试将被用来改进对艾滋病毒发病率的估计，不仅在美国，而且在世界各地的人口中也是如此。

DESCRIPTION (provided by applicant): The objective of this project is to develop a commercially viable single well HIV-1 Limiting Antigen Avidity EIA and establish its suitability fo determination of recency of HIV-1 infection. An accurate tool for distinguishing recent from long-term HIV infections is important in the determination of HIV incidence rates in populations, and may also be useful for providing tailored therapeutic, counseling and contact follow-up of individuals. The assay will be developed based on technology developed and licensed by the U.S. Centers for Disease Control (CDC). Upon completion of technology transfer from the CDC, Sedia will incorporate proprietary technology to develop a robust, stable, user-friendly assay. The project is of significant relevance to the CDC, as the CDC currently manages a national HIV/AIDS surveillance system that is the nation's source for timely information used to track the epidemic in the U.S. The CDC uses HIV recency data from that system to make estimates of HIV incidence and track the epidemic, and is seeking to obtain more accurate data through the use of better assays, such as the HIV-1 Limiting Antigen Avidity EIA. The 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 epidemic, as well as assess effectiveness of intervention programs. Sedia intends to collaborate with the CDC 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, before expanding testing to multiple outside investors in Phase II of the project. PUBLIC HEALTH RELEVANCE: This project is for the development of a commercially viable single well HIV-1 Limiting Antigen Avidity EIA and to establish its suitability for determination o recency of HIV-1 infection. The CDC uses HIV recency data to make estimates of HIV incidence and track the epidemic, and is seeking to obtain more accurate data through the use of better assays, such as the HIV-1 Limiting Antigen Avidity EIA. The assay will be used to generate improved estimates of HIV incidence not only in the U.S., but in populations around the world.