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

用于多重衣原体诊断的低成本无仪器即时护理平台

• 批准号: 8782420
• 负责人: DEBORAH Anne DEAN
• 金额: $ 29.97万
• 依托单位: LUCIRA HEALTH, INC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-15 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8782420
• 关键词: Accident and Emergency department; Acute; Antibiotics; Antibodies; Arthritis; Autoimmune Process; Bacterial DNA; Bacterial Sexually Transmitted Diseases; Bedside Testings; Biological Assay; Care Technology Points; Cervix Uteri; Chemistry; Chlamydia; Chlamydia trachomatis; Chronic; Clinic; Clinical; Clinical Trials; Communicable Diseases; Conjunctivitis; DNA; DNA amplification; Data; Detection; Development; Devices; Diagnosis; Diagnostic; Drug resistance; Early Diagnosis; Epidemic; Equipment; Female; Funding; Genitourinary system; Goals; HIV-1; Human Papillomavirus; Infection; Infertility; Injection of therapeutic agent; Ions; Laboratories; Life; Lymphogranuloma Venereum; Malignant neoplasm of cervix uteri; Marketing; Measures; Medical; Methods; Molds; Morbidity - disease rate; Mothers; Mutate; Nucleic Acid Amplification Tests; Organism; Patients; Pelvic Inflammatory Disease; Pharyngeal structure; Phase; Pneumonia; Procedures; Process; Rectum; Resources; Risk; Risk Factors; Sample Size; Sampling; Scheme; Sensitivity and Specificity; Sexually Transmitted Diseases; Squamous cell carcinoma; Swab; System; Teenagers; Temperature; Testing; TimeLine; Training; Treatment Efficacy; Treatment Protocols; Trichomonas Infections; Ulcer; Urine; Vagina; Visual; Woman; assay development; base; chronic pelvic pain; clinical research site; conjunctiva; cost; design; efficacy testing; experience; follow-up; improved; instrument; male; manufacturing process; meetings; novel; point of care; point-of-care diagnostics; prototype; public health relevance; rapid diagnosis; scale up; screening; stem; transmission process; user-friendly; validation studies

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.

描述（由申请人提供）：在护理点 (POC) 检测衣原体 (Ct) STI 是一项未得到满足的关键医疗需求。有效的 Ct POC 诊断的开发将导致广泛的筛查工作，以进行快速诊断，为治疗提供信息并评估治疗效果，并进行治愈测试，这不仅会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（包括 HIV-1 感染、宫颈癌和自身免疫性关节炎）来提供益处。尽管现有的诊断方法已经存在，但它们仍然昂贵，技术上具有挑战性，灵敏度的一致性各不相同，无法区分菌株类型，需要几天的时间才能得到结果，并且仅限于主要的临床或参考实验室。第一阶段应用的总体目标是开发一种快速、廉价、用户友好、敏感和特异性的 Ct POC 诊断，可用于医生办公室、小型到大型诊所、青少年和性病诊所、急诊室和适当的资源全局受限设置。第一阶段的目标将通过 Deborah Dean 博士和 Diassess 的互补专业知识、设备和设施来实现。在第一阶段，将实现以下目标：1) 拭子处理装置，用于从临床样本中快速（约 10 分钟）提取 DNA，对操作员的要求最低；2）用于快速（约 40 分钟）和多重 Ct 检测的诊断测定开发，以及在廉价平台上进行菌株分型，以及 3) 系统的灵敏度和特异性确定。完成这些目标后，第二阶段将开发注塑制造工艺，从而生产出高度可扩展且低成本的设备。还将分析更大的样本量，包括抑制样本。将针对其他性传播感染（GC、HPV 和毛滴虫病）开发引物，并将其集成到该平台中。此外，还将测试来自其他重要临床部位的样本，包括结膜、咽、尿液、泌尿生殖溃疡、阴道和直肠。要在 2017 年第三季度之前将该产品推向市场，还需要约 300 万美元的额外资金用于扩大规模和临床试验。