Rapid molecular diagnostic for chlamydia and gonorrhea at the point-of-care

在护理点对衣原体和淋病进行快速分子诊断

• 批准号: 8888768
• 负责人: CATHERINE M. KLAPPERICH
• 金额: $ 14.37万
• 依托单位: BOSTON UNIVERSITY (CHARLES RIVER CAMPUS)
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8888768
• 关键词: Antimicrobial Resistance; Australia; Bacterial Infections; Bedside Testings; Biological Assay; Biology; Canada; Care Technology Points; Centers for Disease Control and Prevention (U.S.); Chlamydia; Chlamydia trachomatis; Clinic; Clinical; Clinical Research; Country; DNA; Detection; Devices; Diagnosis; Diagnostic; Ensure; Epidemiology; European; Fetus; Genitourinary system; Goals; Gold; Gonorrhea; Hour; Hybrids; Infection; Japan; Laboratories; Lateral; Learning; Literature; Microfluidics; Molecular; Neisseria gonorrhoeae; Organism; Paper; Patients; Pharmacologic Substance; Plastics; Preparation; Process; Protocols documentation; Reagent; Reporting; Research; Sampling; Sensitivity and Specificity; Sexually Transmitted Diseases; South Africa; Specimen; Swab; System; Technology; Test Result; Testing; United States; Universities; Urine; Visual; amplification detection; antimicrobial; base; cross reactivity; design; high risk; instrumentation; internal control; pathogen; point of care; prenatal; public health relevance; transmission process; validation studies

 DESCRIPTION (provided by applicant): The scientific literature clearly shows that molecular testing, or detecting the DNA of the infecting organisms, is the most sensitive means of detecting the two most frequently occurring bacterial STIs: Chalmydia trachomatis (CT) and Neisseria gonorrhoeae (NG). CT is the most commonly reported bacterial infection in the United States. The CDC estimates that 3 million new cases of chlamydia and 700,000 cases of gonorrhea occur each year in the US. The annual global burden of new NG infections is estimated by the WHO to be 106 million. In the past 5 years, cases of antimicrobial resistant (AMR) NG have been reported and verified in Japan, Australia, several European countries, Canada and South Africa. There are no new antimicrobials for NG in the pharmaceutical pipeline, thus, we may be approaching a day when some NG is no longer treatable. The problem is likely more widespread worldwide, and the lack of sensitive and fast diagnostics in high burden countries are partly to blame. The United States CDC urges clinics to use POC tests if patients are unlikely to return to the clinic to learn the results of the test. Patients tat do not return for results are at a much higher risk for complications and transmission to others. For prenatal patients, a delay in diagnosis and treatment can endanger a fetus. Crucially, in global settings, patients who do not return are often not treated or treat themselves inappropriately using widely available "over the counter" antimicrobials. Clinicians without sensitive diagnostics in these settings will often treat based on symptomatic review, leading to overtreatment. In both cases, the march toward AMR is exacerbated. CT and NG often present simultaneously, which can complicate initial diagnosis of the identification of patients with unsuccessfully treated AMR NG. We propose an integrated sample-to-answer processing, amplification, and detection system for POC STI testing that results in simple and sensitive Yes/No visual readout for CT and NG on a hybrid paper/microfluidic chip. We have previously demonstrated on the bench-top, that each of these steps can be completed for simulated urine samples for both CT and NG in paper/microfluidic chips with minimal instrumentation. Our goal is to develop a portable, inexpensive molecular diagnostic device with minimal instrumentation that can be used at the POC to diagnose and differentiate CT and NG infections. The test will take less than one hour to perform and have and LOD for each organism of less than 1000 copies per sample.

 描述（由申请人提供）：科学文献清楚地表明，分子检测或检测感染生物体的 DNA 是检测两种最常见的细菌性传播感染的最灵敏方法：沙眼衣原体 (CT) 和淋病奈瑟菌 (NG)。 CT 是美国最常报告的细菌感染。疾病预防控制中心估计，美国每年会出现 300 万例新的衣原体病例和 70 万例淋病病例。据世界卫生组织估计，全球每年新增 NG 感染负担为 1.06 亿。过去5年，日本、澳大利亚、多个欧洲国家、加拿大和南非均报告并证实了抗菌素耐药性（AMR）NG病例。制药管道中还没有针对 NG 的新抗菌药物，因此，我们可能即将迎来某些 NG 不再可治疗的一天。这个问题可能在全世界范围内更为普遍，部分原因在于高负担国家缺乏灵敏和快速的诊断。美国疾病预防控制中心敦促诊所在患者不太可能返回诊所了解检测结果的情况下使用 POC 检测。未返回检查结果的患者出现并发症和传播给他人的风险要高得多。对于产前患者来说，延误诊断和治疗可能会危及胎儿。至关重要的是，在全球环境中，没有返回的患者往往得不到治疗，或者使用广泛使用的“非处方”抗菌药物对自己进行不当治疗。在这些情况下，缺乏敏感诊断的临床医生通常会根据症状检查进行治疗，从而导致过度治疗。在这两种情况下，抗菌素耐药性的进展都在加剧。 CT 和 NG 经常同时出现，这会使识别治疗不成功的 AMR NG 患者的初步诊断变得复杂。我们提出了一种用于 POC STI 测试的集成样本到答案处理、放大和检测系统，可在混合纸/微流控芯片上对 CT 和 NG 进行简单而灵敏的“是/否”视觉读数。我们之前已经在台式机上演示过，可以使用最少的仪器完成纸/微流控芯片中 CT 和 NG 的模拟尿液样本的每个步骤。我们的目标是开发一种便携式、廉价的分子诊断设备，只需最少的仪器，可在 POC 中用于诊断和区分 CT 和 NG 感染。该测试的执行时间不到一小时，每个样本的每种生物体的 LOD 少于 1000 个拷贝。