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

描述（由申请方提供）：本项目的目的是开发一种商业上可行的床旁HIV-1发病率快速检测试剂盒，并确定其适用于测定全血、血浆、血清标本中HIV-1感染的近期发生率，以用于流行病学、研究和监测目的。还旨在确定将该测定法应用于干血斑和口腔液标本的可行性。潜在 在项目的第II阶段之前，不打算将检测试剂盒开发为联合发生率/诊断检测试剂盒（包括适用的监管提交）。最近在开发用于区分近期和长期HIV感染的准确测定方面的进展仅限于复杂的基于实验室的测定。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，但没有现成的全面实验室设施。拟议的快速HIV-1发病率测定，一旦确定为适合人群监测使用，也可能最终是有用的，提供定制的治疗，咨询和个人在护理点的接触随访，与诊断一致。该检测方法将基于Sedia Biosciences专有的快速侧向流免疫层析检测技术和美国疾病控制中心（CDC）开发和许可的快速发病率检测技术的组合进行开发。该项目与疾病预防控制中心具有重要意义，因为疾病预防控制中心负责监督一些国内和国际项目，以监测美国和世界各地的艾滋病毒流行，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管理人员也可以使用拟议的检测方法来了解和瞄准HIV流行病，以及评估干预计划的有效性和识别感染的“热点”。Sedia打算与CDC HIV项目的国内和国际分支机构合作，根据CDC的需求和规格开发检测试剂盒，并与CDC合作，使用已知近期的存档横断面血清标本评估所得检测试剂盒，以确定检测的准确性。Sedia还打算通过CEPHIA（HIV发病率测定性能评估联盟）项目来评估HIV发病率测定，然后在项目的第二阶段将测试扩展到多个外部研究者。

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.