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

Nea 一小时内进行病毒载量检测的 Liat HIV 定量分析的临床研究

• 批准号: 7926693
• 负责人: SHUQI CHEN
• 金额: $ 299.98万
• 依托单位: IQUUM, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-29 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7926693
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Acute; Biological Assay; Capital; Clinic; Clinical; Clinical Data; Clinical Research; Clinics and Hospitals; Collaborations; Comb animal structure; Community Health; Cyclic GMP; Decision Making; Detection; Development; Diagnosis; Diagnostic; Disease; Doctor of Philosophy; Dose; Excision; Figs - dietary; Funding; Grant; HIV; HIV-1; Health; Hospitals; Hour; Human Resources; Individual; Infection; Intervention; Label; Laboratories; Life; Manuals; Marketing; Molecular; Monitor; Multi-Institutional Clinical Trial; Nucleic Acid Amplification Tests; Nucleic Acids; Patients; Persons; Phase; Physicians' Offices; Plasma; Polymerase Chain Reaction; Principal Investigator; Process; Qualifying; Quality of Care; Quality of life; RNA; Reagent; Reporting; Research; Research Personnel; Rural Community; Sampling; Scanning; Site; Small Business Innovation Research Grant; Social Welfare; Specificity; Staging; System; Technology; Testing; Therapeutic; Therapeutic Intervention; Time; Training; Treatment Efficacy; Treatment Failure; Tube; United States Food and Drug Administration; United States National Institutes of Health; Validation; Viral Load result; Visit; Washington; Whole Blood; antiretroviral therapy; base; cost; effective intervention; improved; inhibitor/antagonist; novel; operation; outcome forecast; preclinical study; prevent; programs; public health relevance; research clinical testing; touchscreen

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.

描述（由申请方提供）：我们拟在近患者环境中，在不到1小时的时间内完成Liat（tm）HIV-1 Assay的后期开发和临床验证，以定量测定人类免疫缺陷病毒-1（HIV-1）RNA。基于IQuum的试管实验室平台，Liat HIV-1 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、诊所或医生办公室在不到1小时的时间内进行HIV-1检测。该检测方法克服了目前HIV-1检测的局限性，其周转时间长，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访问HIV-1定量检测，我们预计Liat HIV-1检测将允许临床医生及时评估患者预后或监测抗逆转录病毒治疗（ART）。它还可以帮助诊断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。我们建议在本BRDG-SPAN项目下完成Liat HIV-1 Assay的开发和临床验证。我们将与领先的艾滋病临床研究人员合作，对Liat HIV-1 Assay进行临床样本表征和多中心临床研究。在该项目结束时，我们预计将准备提交用于治疗监测和预后的病毒载量测定预期用途的美国食品药品监督管理局（FDA）上市前批准。 公共卫生关系：Liat（tm）HIV-1 Assay通过实现有效和灵敏的单次访问HIV-1定量检测，将使临床医生能够快速识别治疗失败并提供即时有效的干预，从而显著改善HIV-1感染者的生活质量。Liat HIV-1 Assay克服了目前HIV-1检测的局限性，包括周转时间长和技术复杂性，需要在集中实验室进行检测，导致错过或延迟疾病干预的机会。该检测方法也将成为首批近距离检测患者核酸病毒载量的方法之一，并将为患者的健康和福祉带来显著益处。