Rapid Point-of-Care Diagnostic Test for Chlamydia and Gonorrhea

描述（由申请人提供）：研究的总体目标是开发一种快速，即时护理（POC），基于核酸扩增的诊断测试，用于检测沙眼衣原体和淋病奈瑟菌，使用我们创新的“Lab-in-a-tube”（LiatTM）技术。衣原体和淋病是在美国和世界各地报告的第一和第二大性传播疾病。感染沙眼衣原体的女性中有四分之三和男性中有一半是无症状的，因此不寻求医疗照顾。尽管对高发人群进行了系统筛查以发现无症状患者，但在检测结果为阳性的个体中，有相当大比例的人在检测结果出来后没有返回诊所。这些人助长了这些疾病在人群中的进一步传播。虽然快速检测可用于近病人检测这些感染原，但这些检测缺乏检测约40%病例的敏感性。因此，需要一种更敏感的即时检测来减少这些性传播疾病的传播。在我们的I期研究中，IQuum已经证明了快速检测尿液标本中沙眼衣原体核酸的可行性，使用Liat系统在1小时内检测30个基本体（EB） （150 fg）的灵敏度。该系统由Liat分析仪和一次性Liat管组成，可在一个便携式设备中自动完成核酸扩增试验的所有过程，包括试剂制备、靶富集、抑制剂去除、核酸提取、扩增和实时检测。用户将生物样品导入试管后，试管在测试过程中保持关闭状态，从而防止试剂与样品的交叉污染。在II期，我们建议通过开发大容量样品处理设备以及开发针对核糖体核糖核酸的检测来提高检测的灵敏度。IQuum测试的性能将与罗氏和Gen-Probe现有的商业测试进行比较，并将向美国食品药品监督管理局（FDA）提交临床研究计划。在III期临床研究将启动，以获得FDA批准销售用于人类诊断的测试。衣原体和淋病是在美国和世界各地报告的第一和第二大性传播疾病。对衣原体和淋病进行更灵敏的即时检测，将提高接受这些性传播疾病治疗的患者比例，并减少这些有机体在人群中的传播。

DESCRIPTION (provided by applicant): The overall goal of research is to develop a rapid, point-of-care (POC), nucleic acid amplification based diagnostic test for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae using our innovative "Lab-in-a-tube" (LiatTM) technology. Chlamydia and gonorrhea are the first and second most frequently reported sexually transmitted diseases in the United States, and around the World. Three quarters of the women and half of the men infected with C. trachomatis are asymptomatic, and thus do not seek medical attention. Although systematic screening of high incidence groups is performed to find asymptomatic patients, a significant percentage of the individuals testing positive for an infection by these organisms do not return to the clinic after their test results. These individuals contribute to the further spread of these diseases in the population. Although rapid tests are available for near patient detection of these infectious agents, these tests lack the sensitivity to detect approximately 40% of cases. Therefore, a more sensitive point-of-care test is needed to reduce the transmission of these sexually transmitted diseases. In our Phase I research, IQuum has demonstrated the feasibility of rapidly detecting C. trachomatis nucleic acids in urine specimens with a sensitivity of detection of 30 elementary bodies (EB) (150 fg) in less than 1 hour, using our Liat system. This system consists of a Liat Analyzer, and disposable Liat Tubes, which can automate all of the processes involved in a nucleic acid amplification test, including reagent preparation, target enrichment, inhibitor removal, nucleic acid extraction, amplification and real-time detection, in one portable device. After the user introduces the biological sample into the tube, the tube remains closed during the test, thus preventing cross-contamination of reagents with samples. In Phase II, we propose to increase the sensitivity of our assays by developing a large volume sample processing device as well as developing assays targeting ribosomal ribonucleic acids. The performance of the IQuum tests will be compared to existing commercial tests by Roche and Gen-Probe and a clinical study plan will be submitted to the Food & Drug Administration (FDA). In Phase III a clinical study will be launched to obtain FDA clearance for sale of the test for human diagnostics. Chlamydia and gonorrhea are the first and second most frequently reported sexually transmitted diseases in the United States, and around the World. A more sensitive point-of-care test for the detection of chlamydia and gonorrhea will increase the percentage of patients receiving treatment for these sexually transmitted diseases and reduce the spread of these organisms in the population.