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

衣原体和淋病的快速护理点诊断测试

• 批准号: 7159283
• 负责人: DAVID Lee DOLINGER
• 金额: $ 98.36万
• 依托单位: IQUUM, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-15 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7159283
• 关键词: Chlamydiaceae; diagnostic tests; gonorrhea; infection; nucleic acids; sexually transmitted diseases; urine

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.

描述（由申请人提供）：研究的总体目标是开发一种快速、即时（POC）、基于核酸扩增的诊断测试，用于使用我们的创新“试管实验室”（LiatTM）技术检测沙眼衣原体和淋病奈瑟菌。衣原体和淋病是第一和第二最常见的性传播疾病在美国和世界各地。四分之三的女性和一半的男性感染了C。沙眼是无症状的，因此不需要就医。虽然对高发病率群体进行了系统筛查，以发现无症状患者，但在这些生物体感染检测呈阳性的个人中，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患者检测这些传染性病原体，但这些检测缺乏检测约40%病例的灵敏度。因此，需要一种更敏感的护理点测试来减少这些性传播疾病的传播。在我们的第一阶段研究中，IQuum已经证明了快速检测C。使用我们的Liat系统，在不到1小时的时间内，以30个基本小体（EB）（150 fg）的检测灵敏度检测尿液样本中的沙眼核酸。该系统由Liat分析仪和一次性Liat试管组成，可以在一个便携式设备中自动化核酸扩增测试中涉及的所有过程，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。在用户将生物样品引入试管中之后，试管在测试期间保持封闭，从而防止试剂与样品的交叉污染。在第二阶段，我们建议通过开发大容量样本处理设备以及开发靶向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的现有商业测试进行比较，并将向美国食品药品监督管理局（FDA）提交临床研究计划。在第三阶段，将启动一项临床研究，以获得FDA批准销售用于人类诊断的检测试剂。衣原体和淋病是第一和第二最常见的性传播疾病在美国和世界各地。检测衣原体和淋病的更敏感的护理点测试将增加接受这些性传播疾病治疗的患者的百分比，并减少这些生物体在人口中的传播。