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

 描述(由申请人提供)：科学文献清楚地表明，分子检测，或检测感染生物的DNA，是检测两种最常见的细菌性传播感染的最敏感的手段：沙眼衣原体(CT)和淋球菌(NG)。CT是美国最常见的细菌感染报告。美国疾病控制与预防中心估计，美国每年新增300万衣原体病例和70万淋病病例。据世界卫生组织估计，全球每年新增NG感染的负担为1.06亿人。在过去的5年里，日本、澳大利亚、几个欧洲国家、加拿大和南非都报告和核实了抗菌素耐药(AMR)NG病例。在制药管道中，没有针对NG的新的抗菌药，因此，我们可能正在接近一些NG不再可以治疗的日子。这个问题可能在全球范围内更普遍，高负担国家缺乏敏感和快速的诊断是部分原因。美国疾控中心敦促诊所，如果患者不太可能回到诊所了解测试结果，就使用POC测试。TAT患者没有因为结果而回来，发生并发症和传染给其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，在全球环境下，没有返回的患者往往得不到治疗，或者使用广泛可用的“非处方药”抗菌药进行不适当的治疗。在这些环境中没有敏感诊断的临床医生通常会根据症状审查进行治疗，从而导致过度治疗。在这两种情况下，向AMR进军的步伐都在加剧。CT和NG经常同时出现，这会使治疗失败的AMR NG患者的初步诊断复杂化。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，从而在混合纸张/微流控芯片上实现简单且灵敏的CT和NG可视读数。我们之前已经在工作台上演示过，对于纸质/微流控芯片中的CT和NG模拟尿样，只需最少的仪器就可以完成其中的每一个步骤。我们的目标是开发一种便携的、廉价的、使用最少仪器的分子诊断设备，可用于POC诊断和区分CT和NG感染。该测试将在不到一个小时的时间内进行，每个样本的每个有机体的和LOD都不到1000个拷贝。

 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.