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

用于确定 HIV-1 感染新近程度的新型单孔亲和力 EIA

• 批准号: 8263062
• 负责人: Ronald William Mink
• 金额: $ 19.41万
• 依托单位: SEDIA BIOSCIENCES CORPORATION
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8263062
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Agreement; Algorithms; Antigens; Applications Grants; Archives; Avidity; Biological; Biological Assay; Centers for Disease Control and Prevention (U.S.); Characteristics; Consultations; Contact Tracing; Counseling; Data; Development; Diagnostic; Effectiveness; Effectiveness of Interventions; Ensure; Epidemic; Epidemiologist; Evaluation; HIV; HIV Infections; HIV-1; Head; Health Personnel; Health Resources; Housing; Incidence; Individual; Infection; Information Systems; International; Laboratories; Licensing; Methods; Modification; Performance; Persons; Phase; Population; Populations at Risk; Production; Public Health; Reagent; Regimen; Reproducibility; Research; Research Personnel; Serologic tests; Serum; Small Business Innovation Research Grant; Source; Specimen; Staging; Surveillance Program; System; Technology; Technology Transfer; Testing; Therapeutic; Vaccines; Validation; Viral Load result; base; design; follow-up; health organization; improved; intervention program; meetings; novel; population based; programs; scale up; tool; user-friendly

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.

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单井HIV-1限制性抗原贪婪度EIA，并确定其用于确定HIV-1感染近发性的适用性。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非常重要，也可能有助于为个人提供量身定制的治疗、咨询和接触随访。该检测方法将基于美国疾病控制中心（CDC）开发和许可的技术进行开发。在完成从CDC的技术转让后，Sedia将采用专有技术来开发一种强大、稳定、用户友好的检测方法。该项目与美国疾病控制与预防中心（CDC）有着重要的相关性，因为CDC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美国流行病的及时信息来源。CDC使用该系统中的艾滋病毒最新数据来估计艾滋病毒发病率和跟踪流行病，并正在寻求通过使用更好的检测方法（如HIV-1限制性抗原贪婪度EIA）获得更准确的数据。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方法来了解和瞄准流行病，以及评估干预计划的有效性。Sedia计划与CDC合作开展该项目，根据CDC的需求和规范开发该检测方法，并与CDC合作使用已知近期的存档横断面血清标本评估结果，以确定检测的准确性，然后在项目的第二阶段将测试扩展到多个外部投资者。