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: 7281987
• 负责人: DAVID Lee DOLINGER
• 金额: $ 23.31万
• 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 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7281987
• 关键词: Attention; Bedside Testings; Biological; Biological Assay; Cells; Centers for Disease Control and Prevention (U.S.); Chlamydia; Chlamydia Infections; Chlamydia trachomatis; Classification; Clinic; Clinical Research; Clinical Trials; DNA; Data; Detection; Devices; Diagnostic; Diagnostic tests; Disease; Epithelial Cells; Excision; Figs - dietary; Fimbriae Proteins; Genes; Goals; Gonorrhea; HIV; Health; Homologous Protein; Hour; Human; Incidence; Individual; Infection; Infectious Agent; Infertility; Legal patent; Medical; Medical Surveillance; Neisseria gonorrhoeae; Nucleic Acid Amplification Tests; Nucleic Acids; Organism; Patients; Pelvic Inflammatory Disease; Performance; Phase; Phase II Clinical Trials; Physicians' Offices; Population; Preparation; Process; Protocols documentation; Public Health; RNA; Range; Rate; Reagent; Reporting; Research; Ribosomal RNA; Risk; Sales; Sampling; Scanning; Screening procedure; Sensitivity and Specificity; Sexually Transmitted Diseases; Site; Specimen; System; Technology; Test Result; Testing; Time; Tube; United States; United States Food and Drug Administration; Urination; Urine; Virus Diseases; Visit; Whole Blood; Woman; base; cost; inhibitor/antagonist; innovation; men; point of care; preclinical study; prevent; transmission process

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、即时护理 (POC)、基于核酸扩增的诊断测试，使用我们创新的“试管实验室”(LiatTM) 技术来检测沙眼衣原体和淋病奈瑟菌。衣原体和淋病是美国和世界各地最常报告的第一和第二性传播疾病。感染沙眼衣原体的四分之三的女性和一半的男性没有症状，因此不会就医。尽管对高发病率群体进行了系统筛查以寻找无症状患者，但这些微生物感染检测呈阳性的个体中，很大一部分在检测结果出来后并没有返回诊所。这些人导致这些疾病在人群中进一步传播。尽管快速检测可用于在患者附近检测这些传染源，但这些检测缺乏检测大约 40% 病例的灵敏度。因此，需要更灵敏的现场检测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 证明了使用我们的 Liat 系统快速检测尿液样本中沙眼衣原体核酸的可行性，其灵敏度可在不到 1 小时内检测到 30 个基本体 (EB) (150 fg)。该系统由一台Liat分析仪和一次性Liat管组成，可以在一台便携式设备中自动完成核酸扩增测试中涉及的所有流程，包括试剂制备、靶点富集、抑制剂去除、核酸提取、扩增和实时检测。用户将生物样本引入试管后，测试期间试管保持关闭状态，从而防止试剂与样本的交叉污染。在第二阶段，我们建议通过开发大容量样品处理装置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，临床研究计划将提交给美国食品和药物管理局 (FDA)。在第三阶段，将启动一项临床研究，以获得 FDA 批准销售该人体诊断测试。衣原体和淋病是美国和世界各地最常报告的第一和第二性传播疾病。用于检测衣原体和淋病的更灵敏的护理点测试将增加接受这些性传播疾病治疗的患者比例，并减少这些微生物在人群中的传播。