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（由申请人提供）：我们建议在患者附近完成用于人类免疫缺陷病毒-1 (HIV-1) RNA 定量的 Liat(tm) HIV-1 检测的后期开发和临床验证，时间不超过 1 小时。 Liat HIV-1 Assay 基于 IQuum 的管中实验室平台，将利用 Liat 分析仪，使经过最低限度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。该检测克服了当前 HIV-1 检测的局限性，其周转时间长且技术复杂，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且灵敏的单次访问 HIV-1 定量检测，我们预计 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)。它还可能有助于诊断 HIV-1 感染，包括急性感染。这种实时决策可以更有效地防止临床进展，为艾滋病毒感染者提供更高的护理质量。我们建议在 BRDG-SPAN 计划下完成 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 检测进行临床样本表征并进行多中心临床研究。在该计划结束时，我们预计将准备好提交美国食品和药物管理局 (FDA) 的上市前批准，以用于治疗监测和预后的病毒载量测定的预期用途。 公共卫生相关性：通过实现有效且灵敏的单次就诊 HIV-1 定量检测，Liat(tm) HIV-1 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措施，从而显着改善 HIV-1 感染者的生活质量。 Liat HIV-1 检测克服了当前 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，从而导致错过或延迟疾病干预的机会。该检测也将成为首批近距离患者核酸病毒载量检测之一，将为患者的健康和福利带来重大益处。