Development of Point-of-Care Liat? Quantitative HIV Assay

描述（由申请人提供）：我们建议基于IQuum的试管实验室（Liat（tm））平台开发一种高灵敏度、特异性、可重复性和快速的即时核酸检测，用于检测和定量感染患者中的HIV-1 M组病毒。Liat HIV Assay将利用Liat分析仪，使经过最低限度培训的人员能够在医院、诊所、农村卫生中心、医生办公室或现场进行HIV-1定量检测。通过实现有效和灵敏的HIV-1定量检测，我们预计Liat检测试剂盒将：（i）让临床医生识别受艾滋病病毒1型感染的志愿者，以进行临床试验（疫苗和治疗试验），（ii）允许临床医生监测临床试验，快速检测方法用于确定感染患者的疫苗治疗益处，（iii）由医护人员检测急性感染病人体内的HIV-1病毒并进行定量，（iv）允许对正在接受高效抗逆转录病毒疗法（HAART）的感染患者进行护理点（point-of-care）真实的时间测试，从而允许治疗医师能够做出治疗决定，以及（v）由于母体抗体和样本量的原因，儿科患者的检测非常复杂。Liat HIV Assay克服了目前HIV-1检测的局限性，其周转时间长和技术复杂性要求在集中实验室进行检测，由于患者大量失访以及缺乏对美国和国外资源贫乏地区的渗透，导致错过了疾病预防的机会。在该项目的第一阶段，我们打算证明快速自包含样品到结果Liat HIV-1定量检测的可行性和初步验证。这将通过将现有的商业化HIV-1检测化学移植和优化到Liat系统来完成。我们还打算表征和验证Liat HIV Assay能够定量M组内所有亚型的代表性样本。在本项目结束时，我们将准备将Liat HIV检测试剂盒进行下一级验证和分析表征。该检测将成为首批即时核酸检测之一，并将为公共卫生提供重大益处。Liat HIV Assay将利用Liat分析仪，使经过最低限度培训的人员能够在医院、诊所、农村卫生中心、医生办公室或现场进行HIV-1定量检测。通过实现有效和灵敏的HIV-1定量检测，我们预计Liat检测试剂盒将：（i）让临床医生识别受艾滋病病毒1型感染的志愿者，以进行临床试验（疫苗和治疗试验），（ii）允许临床医生监测临床试验，快速检测方法用于确定感染患者的疫苗治疗益处，（iii）由医护人员检测急性感染病人体内的HIV-1病毒并进行定量，（iv）允许对正在接受高效抗逆转录病毒疗法（HAART）的感染患者进行护理点（point-of-care）真实的时间测试，从而允许治疗医师能够做出治疗决定，以及（v）由于母体抗体和样本量的原因，儿科患者的检测非常复杂。Liat HIV Assay克服了目前HIV-1检测的局限性，其周转时间长和技术复杂性要求在集中实验室进行检测，由于患者大量失访以及缺乏对美国和国外资源贫乏地区的渗透，导致错过了疾病预防的机会。

DESCRIPTION (provided by applicant): We propose to develop a highly sensitive, specific, reproducible and rapid point-of-care nucleic acid test based on IQuum's lab-in-a-tube (Liat(tm)) platform for the detection of and quantification of HIV-1 Group M virus in infected patients. The Liat HIV Assay will utilize the Liat Analyzer to enable minimally trained personnel the ability to perform the HIV-1 Quantitative test at a hospital, clinic, rural health center, physician's office or in the field. By enabling effective and sensitive HIV-1 quantitative testing, we expect that the Liat assay will: (i) allow clinicians to identify HIV-1 infected volunteers for clinical trials (both vaccine and treatment trials), (ii) allow clinicians monitoring clinical trials a rapid testing methodology for the determination of vaccine treatment benefit in infected patients, (iii) health personnel to detect and quantitate HIV-1 virus in acutely infected patients, (iv) allow point-of-care real time testing of infect patients on highly active antiretroviral therapy (HAART) allowing treating physicians the ability to make treatment decisions and (v) testing of pediatric patients where testing is complex due to maternal antibodies and sample volumes. The Liat HIV Assay overcomes the limitations of current HIV-1 tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for disease prevention due to significant patient loss to follow-up and lack of penetration into resource-poor regions in the US and abroad. In Phase I of this project, we intend to prove the feasibility and initial verification of a rapid-self contained sample-to-result Liat HIV-1 Quantitative Assay. This will be done by the porting and optimize the existing commercialized HIV-1 assay chemistry to the Liat system. We further intend to characterize and verify that the Liat HIV Assay has the capability of quantifying representative samples from all subtypes within Group M. At the conclusion of this project, we will be prepared to carry the Liat HIV assay to the next level of validation and analytical characterization. The assay will be among the first point-of-care nucleic acid tests, and will provide significant benefit to public health. The Liat HIV Assay will utilize the Liat Analyzer to enable minimally trained personnel the ability to perform the HIV-1 Quantitative test at a hospital, clinic, rural health center, physician's office or in the field. By enabling effective and sensitive HIV-1 quantitative testing, we expect that the Liat assay will: (i) allow clinicians to identify HIV-1 infected volunteers for clinical trials (both vaccine and treatment trials), (ii) allow clinicians monitoring clinical trials a rapid testing methodology for the determination of vaccine treatment benefit in infected patients, (iii) health personnel to detect and quantitate HIV-1 virus in acutely infected patients, (iv) allow point-of-care real time testing of infect patients on highly active antiretroviral therapy (HAART) allowing treating physicians the ability to make treatment decisions and (v) testing of pediatric patients where testing is complex due to maternal antibodies and sample volumes. The Liat HIV Assay overcomes the limitations of current HIV-1 tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for disease prevention due to significant patient loss to follow-up and lack of penetration into resource-poor regions in the US and abroad.