Low-Cost Instrument-free Point-of-care Platform for Multiplexed Chlamydia Diagnos

描述(由申请人提供)：在护理点(POC)检测衣原体(CT)性传播感染代表严重的未得到满足的医疗需求。开发有效的CT POC诊断将导致广泛的筛查工作，以便进行快速诊断，为治疗和评估治疗效果提供信息，并进行治愈测试，这不仅将减少与这些感染直接相关的急性和慢性发病率，而且还可以通过减少潜在的附带风险而带来好处，包括艾滋病毒-1感染、宫颈癌和自身免疫驱动的关节炎。尽管目前存在诊断方法，但它们仍然昂贵，在技术上具有挑战性，敏感度一致性不同，不能菌株类型，需要数天才能得出结果，并且仅限于主要的临床或参考实验室。这一第一阶段应用的总体目标是S开发一种快速、廉价、用户友好、灵敏和特异的CT PoC诊断方法，可用于全球医生办公室、大大小小的诊所、青少年和性病诊所、急诊室以及适当的资源受限环境。第一阶段的目标将通过黛博拉·迪恩博士和迪亚斯特博士的补充专业知识、设备和设施来实现。在第一阶段，将实现以下目标：1)一个拭子处理单元，用于从临床样本中快速(~10分钟)提取DNA，操作人员要求最低；2)诊断方法的开发，用于在廉价的平台上快速(~40分钟)和多重CT检测和菌株分型；以及3)该系统的灵敏度和特异性测定。在完成这些目标后，将在第二阶段开发注塑制造工艺，从而产生高度可扩展和低成本的设备。更大的样本量，包括抑制样本也将被分析。将开发针对其他性传播感染(GC、HPV和滴虫病)的引物，并将其整合到该平台中。此外，还将检测来自其他重要临床部位的样本，包括结膜、咽部、尿液、泌尿生殖器溃疡、阴道和直肠。到2017年第三季度，将需要大约300万美元的额外资金来扩大规模和进行临床试验，才能将该产品推向市场。

DESCRIPTION (provided by applicant): Detecting Chlamydia (Ct) STIs at the point-of-care (POC) represents a critical unmet medical need. Development of an effective Ct POC diagnostic will result in widespread screening efforts for rapid diagnosis to inform treatment and evaluate treatment efficacy, and for test-of-cure that would not only reduce the acute and chronic morbidity that is directly associated with these infections, but could also provide benefit by reducing potential collateral risks, including HIV-1 infection, cervical cancer, and autoimmune-driven arthritis. Although current diagnostics exist, they remain expensive, are technically challenging, vary in concordance for sensitivity, cannot strain type, take days for results, and ar confined to major clinical or reference laboratories. The overall goal of this Phase I application s to develop a rapid, cheap, user-friendly, sensitive and specific Ct POC diagnostic that can be used in doctor's offices, small to large clinics, teen and STD clinics, emergency rooms, and appropriate resource constrained settings globally. The Aims of Phase I will be met with the complementary expertise, equipment, and facilities of Dr. Deborah Dean and Diassess. During Phase I, the following will be achieved: 1) a swab processing unit for rapid (~10 min) DNA extraction from clinical samples with minimal operator requirements, 2) diagnostic assay development for rapid (~40 min) and multiplexed Ct detection and strain typing on an inexpensive platform, and 3) sensitivity and specificity determination of the system. Upon completion of these objectives, in Phase II the injection molding manufacturing processes will be developed, leading to highly scalable and low cost devices. A larger sample size, including inhibitory samples will also be analyzed. Primers will be developed against other STIs (GC, HPV, and Trichomoniasis) and integrated into the platform. Additionally, samples from other important clinical sites, including the conjunctiva, pharynx, urine, urogenital ulcer, vagina, and rectum will be tested. Additional funds of ~$3 million, for scale up and clinical trials, will be required to have this product in market by Q3 2017.