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Closed-Tube Nucleic Acid Diagnostic system

闭管核酸诊断系统

基本信息

批准号：
7009766
负责人：
SHUQI CHEN
金额：
$ 315.93万
依托单位：
IQUUM, INC.
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-09-30 至 2008-10-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7009766
关键词：
Rickettsia bacteria bacterial disease bacterial genetics biohazard detection bioterrorism /chemical warfare clinical research communicable disease diagnosis cooperative study diagnosis design /evaluation diagnostic tests human subject nucleic acid quantitation /detection nucleic acid sequence polymerase chain reaction rapid diagnosis septicemia

项目摘要

DESCRIPTION (provided by applicant): This application offers an innovative solution for improving the Nation's capability in diagnostics for biodefense. Currently Sentinel Labs of the Laboratory Response Network (LRN) performs routine tests that might rule out a biological warfare agent but often cannot perform follow-up tests because these might be too hazardous for BSL2 facilities or are too complex. These more complex and biohazardous tests must be performed at Reference or National Labs of the LRN. IQuum has developed a Lab-in-a-Tube (Liat(tm)) technology which could be used at Sentinel Labs to detect Bioterror agents within 1 hour of patient presentation with symptoms associated with a possible bioterror attack. The Liat system enables minimally trained healthcare practitioners to perform a complex nucleic acid test using whole blood as a sample input. As the Liat system uses a closed tube to perform all sample processing operations, tissue processing and extraction of nucleic acids of agents that require BSL3 and BSL4 confinement for these operations could be performed in BSL2 facilities. We propose to develop a rapid reverse transcriptase polymerase chain reaction (RT-PCR) assay on the Liat system for the diagnosis of bacterial and rickettsial bioterror agents using the 16s rRNA gene. Because each bacterium contains 1,000 to 10,000 copies of rRNA, the RT-PCR assay is expected to have highly sensitive bacteremia detection. By exploiting sequence variation between the variable domains of the 16S rRNA of different strains, it will be possible to further characterize the amplification products to identify the putative causative agent(s) of a given pathology. In addition, we will use a second test targeting the groE/OmpB/gltA genes to further refine the identification of pathogens. IQuum will collaborate with Tufts University to characterize the 16s rRNA assays as well as with the Naval Medical Research Center (NMRC) to characterize the groEL/OmpB/gltA assays in pre-clinical trials using simulated clinical samples.

描述（由申请人提供）：该应用程序提供了一个创新的解决方案，以提高国家的能力，在诊断生物防御。目前，实验室反应网络（LRN）的哨兵实验室进行可能排除生物战剂的例行测试，但往往不能进行后续测试，因为这些测试对BSL 2设施来说太危险或太复杂。这些更复杂和生物危害性的测试必须在LRN的参考或国家实验室进行。IQuum开发了一种试管实验室（Liat（tm））技术，可在哨兵实验室使用，在患者出现与可能的生物恐怖袭击相关的症状后1小时内检测生物恐怖制剂。Liat系统使受过最低限度培训的医疗从业人员能够使用全血作为样本输入进行复杂的核酸检测。由于Liat系统使用封闭管进行所有样本处理操作，因此这些操作需要BSL 3和BSL 4限制的试剂的组织处理和核酸提取可在BSL 2设施中进行。我们建议开发一种快速的逆转录聚合酶链反应（RT-PCR）检测的Liat系统的诊断细菌和立克次体生物恐怖剂使用的16 S rRNA基因。由于每种细菌含有1，000至10，000个rRNA拷贝，因此预计RT-PCR检测具有高度灵敏的菌血症检测。通过利用不同菌株的16 S rRNA的可变结构域之间的序列变异，将有可能进一步表征扩增产物以鉴定给定病理的推定致病剂。此外，我们将使用针对groE/OmpB/gltA基因的第二种测试来进一步完善病原体的鉴定。IQuum将与塔夫茨大学合作，对16 s rRNA检测进行表征，并与海军医学研究中心（NMRC）合作，使用模拟临床样本在临床前试验中对groEL/OmpB/gltA检测进行表征。