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

 描述（由申请方提供）：科学文献明确表明，分子检测或检测感染微生物的DNA是检测两种最常见细菌性STI的最灵敏方法：沙眼衣原体（CT）和淋病奈瑟菌（NG）。CT是美国最常见的细菌感染。疾病预防控制中心估计，在美国每年有300万例衣原体和70万例淋病新发病例。据WHO估计，全球每年新发NG感染的负担为1.06亿。在过去5年中，日本、澳大利亚、几个欧洲国家、加拿大和南非报告并证实了耐药性（AMR）NG病例。在制药管道中没有新的NG抗菌药物，因此，我们可能会接近一些NG不再可治疗的一天。这一问题可能在全球范围内更为普遍，高负担国家缺乏敏感和快速的诊断方法是部分原因。美国疾病控制和预防中心敦促诊所使用POC测试，如果病人不太可能返回诊所了解测试结果。病人没有返回结果是在并发症和传播给他人的风险要高得多。对于产前患者，诊断和治疗的延误可能危及胎儿。至关重要的是，在全球环境中，没有返回的患者往往没有得到治疗，或者使用广泛可用的“非处方”抗菌剂对自己进行不适当的治疗。在这些情况下，没有敏感诊断的临床医生通常会根据症状审查进行治疗，导致过度治疗。在这两种情况下，AMR的进展都在加剧。CT和NG通常同时出现，这可能使识别治疗失败的AMR NG患者的初步诊断复杂化。我们提出了一个集成的样品到答案的处理，扩增和检测系统的POC STI测试，结果在简单和敏感的是/否视觉读出CT和NG的混合纸/微流控芯片。我们之前已经在工作台上证明，这些步骤中的每一个都可以用最少的仪器在纸/微流体芯片中完成CT和NG的模拟尿样。我们的目标是开发一种便携式，廉价的分子诊断设备，最少的仪器，可用于在POC诊断和区分CT和NG感染。该检测将在不到1小时的时间内进行，并且每个样本的每种微生物的LOD小于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.