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的试管实验室（Liat）平台开发一种高灵敏度和快速的即时核酸检测，用于从全血样本中诊断登革热或登革出血热患者。Liat Dengue Assay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，我们预计Liat检测将允许临床医生快速诊断登革热或登革出血热患者，并开始适当的治疗。Liat Dengue Assay克服了目前登革热感染检测的局限性，其周转时间长，技术复杂，需要在集中实验室进行检测，导致错过疾病治疗机会或继续使用无效的治疗方案。该检测方法也将是首批近距离患者核酸检测方法之一，将为患者健康和福利提供重大益处，并加强对这一新出现疾病的准备。 在第一阶段，我们建议将Liat Dengue Assay转移到生产中，并进行分析灵敏度和特异性研究。在第二阶段，我们建议完成分析研究，开发和验证Liat Dengue Assay的生产工艺，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时，我们将向FDA提交研究前器械豁免（pre-IDE），为Liat Dengue Assay的510（K）上市许可扩展临床研究做准备。 公共卫生相关性：通过实现有效和敏感的登革热感染检测，Liat”登革热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。Liat Dengue Assay克服了目前登革热感染检测的局限性，其周转时间长，技术复杂，需要在集中实验室进行检测，导致错过疾病治疗机会或继续使用无效的治疗方案。该检测也将是首批近距离患者核酸检测之一，将为患者健康和福利提供重大益处，并加强对这一新出现疾病的准备。

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.