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：
9040881
负责人：
CATHERINE M. KLAPPERICH
金额：
$ 41.71万
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/9040881
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 Health Hour Hybrids Infection Japan Laboratories Lateral Learning Literature Microfluidic Microchips Molecular Neisseria gonorrhoeae Organism Paper Patients Pharmacologic Substance 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 molecular diagnostics pathogen point of care prenatal 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（通过应用得出）：科学文献表明，分子检测最敏感的方法是检测最自由的细菌性STI：Charmydia trachomatis（CT）和Neisseria Gonorrhoeae（NG）CT是美国最常见的细菌。 CDC估计，在美国，新NG感染的年度全球负担估计为300万个新的衣原体和700,000例ORRHEA。（AMR）在日本，加拿大和南非的严重程度上进行了验证和验证。如果诊所与诊所不同，则更多的诊断国家应归咎于美国疾病预防疾病的诊所。诊断和信任可以在这些环境中具有敏感的诊断剂。 AMR NG。我们提出了用于POC测试的集成样本到答案，放大和检测系统，导致在台式上进行简单且敏感的是/否CT CT和NG的视觉读数这些步骤可以完成用纸张/微流体芯片的模拟尿液样品，并具有最小的仪器。每个样品少于1000份的每个生物的执行和LOD一个小时。