Clinical Study for Liat HIV Quant Assay for Viral Load Testing in One Hour in Nea

描述（由申请人提供）：我们建议在不到1小时的时间内完成Liat(tm) HIV-1检测的后期开发和临床验证，用于人类免疫缺陷病毒1 (HIV-1) RNA的定量。基于IQuum的试管实验室平台，Liat HIV-1检测将利用Liat分析仪，使受过最低培训的人员能够在不到1小时的时间内在医院、诊所或医生办公室进行HIV-1检测。这种检测方法克服了当前HIV-1检测方法的局限性，这些方法的周转时间长，技术复杂，需要在集中实验室进行检测，导致延迟或错过及时治疗干预的机会。通过在患者附近进行有效和敏感的单次HIV-1定量检测，我们期望Liat HIV-1检测将使临床医生能够及时评估患者预后或监测抗逆转录病毒治疗（ART）。它也可能有助于诊断HIV-1感染，包括急性感染。这种实时决策可以更有效地预防临床进展，为艾滋病毒感染者提供更高质量的护理。我们建议在BRDG-SPAN项目下完成Liat HIV-1检测的开发和临床验证。我们将与领先的临床艾滋病研究人员合作，对Liat HIV-1检测进行临床样品表征和多位点临床研究。在该项目结束时，我们预计准备向美国食品和药物管理局（FDA）提交上市前批准，用于治疗监测和预后的病毒载量测定。

DESCRIPTION (provided by applicant): We propose to complete the late stage development and clinical validation of the Liat(tm) HIV-1 Assay for the quantitation of Human Immunodeficiency Virus-1 (HIV-1) RNA in less than 1 hour in near patient settings. Based on IQuum's lab-in-a-tube platform, the Liat HIV-1 Assay will utilize the Liat Analyzer to enable minimally trained personnel to perform the HIV-1 test at a hospital, clinic or physician's office in less than 1 hour. The assay overcomes the limitations of current HIV-1 tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories and results in delayed or missed opportunities for timely therapeutic intervention. By enabling effective and sensitive single-visit HIV-1 quantitative testing at the near patient setting, we expect that the Liat HIV-1 assay will allow clinicians to timely assessing patient prognosis or the monitoring of antiretroviral therapy (ART). It may also aid in the diagnosis of HIV-1 infection, including acute infection. This real-time decision making can more effectively prevent clinical progression, providing increased quality of care for HIV-infected individuals. We propose to complete the development and clinical validation of the Liat HIV-1 Assay under this BRDG-SPAN program. We will perform clinical sample characterization and conduct multi-site clinical study on the Liat HIV-1 Assay in collaboration with leading clinical AIDS researchers. At the end of this program, we expect to be prepared to submit for Food and Drug Administration (FDA) Pre-Market Approval for the intended use of viral load determination for therapeutic monitoring and prognosis. PUBLIC HEALTH RELEVANCE: By enabling effective and sensitive single visit HIV-1 quantitative testing, the Liat(tm) HIV-1 Assay will allow clinicians to quickly identify treatment failure and provide immediate and effective intervention, thereby significantly improving the quality of life for HIV-1 infected persons. The Liat HIV-1 Assay overcomes the limitations of current HIV-1 tests, including long turnaround time and technical complexity requiring testing to be performed in centralized laboratories and results in missed or delayed opportunities for disease intervention. The assay will also be among the first near-patient nucleic acid viral load tests, and will provide significant benefit to patient health and welfare.