Automated point-of-care PCR for hemorrhagic fever diagnosis

描述（由申请人提供）：本项目的总体目标是开发一种经验证的全自动、便携式、即时核酸检测系统，用于快速诊断NIAID A-C类生物防御病原体引起的出血热综合征。病毒性出血热的实验室诊断目前因需要专门的实验室和技术专长而变得复杂。由此导致的疑似病毒性出血热确诊延迟是流行地区临床护理和发达国家生物防御准备的一个问题。IQuum，Inc.拥有专利的“试管实验室”（Liat（tm））技术，该技术代表了向哨点或现场实验室提供出血热病毒诊断能力的有前途的方法。Liat系统由专有的检测管系统和分析仪设备组成，提供了一个封闭的系统，用于快速、自动化的标本处理和核酸检测。该项目提出了马萨诸塞州大学的病毒学家、IQuum公司的工程师和美洲热带地区的合作者之间的合作研究和开发计划，以推进Liat系统的开发，该系统专门用于快速和灵敏地检测病毒性出血热病原体。该项目的具体目标是：1。推进Liat分析仪的工程设计，以提高可靠性，易于制造，并增强多重分析能力，从而产生适合在哨兵和现场实验室部署的分析仪。2.确定和优化NIAID A-C类病毒引起的病毒性出血热综合征的诊断和预后评估方法。我们的重点将是开发检测和定量血清和全血中登革热病毒RNA的检测方法，并将扩展到开发登革热预后标志物和检测其他出血热病原体的检测方法。3.开发适合向FDA提交IDE申请的临床前和临床数据组合，以批准用于登革热病毒感染的Liat鉴别诊断试验。该项目将推进一种新型封闭式全自动检测平台的开发，该平台适用于导致出血热的病毒的一线（床旁）检测。检测方法验证最初将侧重于商业上可行的检测登革热病毒的检测方法，并扩展到检测其他病毒。

DESCRIPTION (provided by applicant): The overall objective of this project is to develop a validated fully automated, portable, point-of-care nucleic acid detection system for rapid diagnosis of hemorrhagic fever syndromes caused by NIAID category A-C biodefense pathogens. The laboratory diagnosis of viral hemorrhagic fever is currently complicated by the need for specialized laboratories and technical expertise. The resulting delays in definitive diagnosis of suspected viral hemorrhagic fever is a problem for clinical care in endemic regions and for biodefense readiness in developed countries. IQuum, Inc. has a proprietary "laboratory-in-a-tube" (Liat(tm)) technology that represents a promising approach to provide diagnostic capability for hemorrhagic fever viruses to sentinel or field laboratories. The Liat system, consisting of a proprietary assay tube system and analyzer device, provides a closed system for rapid, automated specimen handling and nucleic acid detection. This project proposes a cooperative research and development program between virologists at the University of Massachusetts, engineers at IQuum, Inc, and collaborators in tropical areas in the Americas to advance the development of the Liat system specifically for the rapid and sensitive detection of viral hemorrhagic fever agents. The Specific Aims of the project are: 1. To advance the engineering of the Liat Analyzer for improved reliability, ease of manufacture, and enhanced multiplex assay capability assays, thus yielding analyzers suitable for deployment in sentinel and field laboratories. 2. To define and optimize assays for diagnosis and prognostic evaluation of viral hemorrhagic fever syndromes caused by NIAID category A-C viruses. Our focus will be on development of assays for detection and quantitation of dengue viral RNA in serum and whole blood, and will extend to development of assays for prognostic markers in dengue and for detection of other hemorrhagic fever pathogens. 3. To develop a portfolio of pre-clinical and clinical data suitable for an IDE filing with the FDA for approval of the Liat differential diagnostic assay for dengue virus infection. This project will advance the development of a novel closed, fully automated assay platform suitable for front-line (point of care) detection of viruses that cause hemorrhagic fevers. Assay validation will focus initially on a commercially viable assay for detecting dengue virus and be extended to detection of other viruses.