Automated Molecular Diagnostics for Rapid Detection of Dengue Viremia Using Whole

描述（由申请人提供）：我们建议基于IQuum的实验室-in-a-tube （Liat）平台开发一种高灵敏度和快速的即时护理核酸检测方法，用于从全血样本中诊断登革热或登革出血热患者。Liat登革热检测将利用Liat分析仪，使受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登革热感染检测。通过实现有效和敏感的登革热感染检测，我们期望Liat检测将使临床医生能够快速诊断登革热或登革出血热患者并开始适当的治疗。利亚特登革热化验克服了目前登革热感染检测的局限性，这些检测的周转时间长，技术复杂，需要在集中实验室进行检测，导致错过了疾病治疗的机会，或继续使用无效的治疗方案。该检测也将是首批近患者核酸检测之一，将为患者的健康和福利带来重大益处，并加强对这种新出现疾病的防范。在I期，我们建议将Liat登革热检测转移到生产中，并进行分析敏感性和特异性研究。在II期，我们建议完成分析研究，开发和验证Liat登革热检测的制造工艺，并进行临床样本研究以验证该检测方法。在临床前和分析研究结束后，我们将向FDA提交一份研究前器械豁免（pre-IDE），为Liat登革热检测的扩大临床研究进行510(K)市场许可做准备。

DESCRIPTION (provided by applicant): We propose to develop a highly sensitive and rapid point-of-care nucleic acid test based on IQuum's lab-in-a-tube (Liat") platform for the diagnosis of patients with dengue fever or dengue hemorrhagic fever from whole blood samples. The Liat Dengue Assay will utilize the Liat Analyzer to enable the minimally trained personnel to perform the dengue infection test at a hospital, clinic or physician's office in less than 1 hour. By enabling effective and sensitive dengue infection testing, we expect that the Liat assay will allow clinicians to quickly diagnose patients with dengue fever or dengue hemorrhagic fever and initiate appropriate treatments. The Liat Dengue Assay overcomes the limitations of current dengue infection tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for disease treatment or the continued use of ineffective treatment regimens. The assay will also be among the first near patient nucleic acid tests, and will provide significant benefit to patient health and welfare, as well as enhance the preparedness for this emerging disease. In Phase I, we propose to transfer the Liat Dengue Assay to manufacturing and perform analytical sensitivity and specificity studies. In Phase II, we propose to complete the analytical studies, develop and validate manufacturing processes for the Liat Dengue Assay, and conduct clinical sample study to validate the assay. At the conclusion of the pre-clinical and analytical studies, we will submit a pre-investigational device exemption (pre-IDE) to the FDA in preparation for expanded clinical study of the Liat Dengue Assay for 510(K) market clearance. PUBLIC HEALTH RELEVANCE: By enabling effective and sensitive dengue infection testing, the Liat" Dengue Assay will allow clinicians to quickly diagnose patients with dengue fever or dengue hemorrhagic fever. The Liat Dengue Assay overcomes the limitations of current dengue infection tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for disease treatment or the continued use of ineffective treatment regimens. The assay will also be among the first near patient nucleic acid tests, and will provide significant benefit to patient health and welfare, as well as to enhance the preparedness for this emerging disease.