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

基本信息

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
项目类别：
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

项目摘要

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，CDC 估计新增 300 万例衣原体病例和 70 万例衣原体感染病例。世界卫生组织估计，美国每年都会发生淋病，全球每年新增 NG 感染人数为 1.06 亿。在过去的 5 年里，日本、澳大利亚、澳大利亚等国均报告并证实了抗生素耐药性 (AMR) NG 病例。一些欧洲国家、加拿大和南非的药物研发中还没有针对 NG 的新抗菌药物，因此，某些 NG 问题可能会在全球范围内变得更加普遍，而且这一问题可能即将到来。如果患者不太可能返回诊所了解检测结果，美国疾病预防控制中心敦促诊所使用 POC 检测，这在一定程度上是造成这种情况的原因。对于产前患者来说，诊断和治疗的延误可能会危及胎儿，这一点至关重要，在全球范围内，未返回的患者往往得不到治疗或使用广泛可用的“过度治疗”进行不当治疗。柜台”在这些情况下，缺乏敏感诊断的临床医生通常会根据症状进行治疗，从而导致过度治疗，而 CT 和 NG 往往同时出现，这会使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，可在混合设备上对 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，可以用最少的仪器完成纸质/微流体芯片中 CT 和 NG 的模拟尿液样本，我们的目标是开发一种便携式、廉价的仪器。具有最少仪器的分子诊断设备，可在 POC 中用于诊断和区分 CT 和 NG 感染。该测试只需不到一小时即可完成，并且每个样本的每种生物体的 LOD 少于 1000 个拷贝。