Rapid, Point-of-Need Diagnostic for Sexually Transmitted Infections

性传播感染的快速、按需诊断

• 批准号: 10268054
• 负责人: Chang Hee Kim
• 金额: $ 29.76万
• 依托单位: GODX, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-23 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10268054
• 关键词: 3D Print; Antibiotic Resistance; Antibiotic Therapy; Antibiotic susceptibility; Antibiotics; Azithromycin; Benchmarking; Biological Assay; Case Study; Cephalosporin Resistance; Cephalosporins; Chlamydia; Chlamydia Infections; Chlamydia trachomatis; Ciprofloxacin; Clinic; Clinical; Communities; DNA; Detection; Development; Devices; Diagnosis; Diagnostic; Drug-resistant Neisseria Gonorrhoeae; Electricity; Elements; Gene Targeting; Genetic Markers; Goals; Gonorrhea; Gynecologist; Hand; Health; Health Care Costs; Health Personnel; Heating; Human; Human Resources; Individual; Infection; Infertility; Infrastructure; Laboratories; Laboratory Technicians; Lateral; Macrolides; Microfluidics; Molecular; Monitor; Movement; Multi-Drug Resistance; Mutation; Neisseria gonorrhoeae; Nucleic Acid Amplification Tests; Nucleic Acids; Paper; Pathogen detection; Patients; Pelvic Inflammatory Disease; Performance; Phase; Polymerase; Predisposition; Pregnancy Complications; Premature Labor; Preparation; Recovery; Refrigeration; Reporting; Resistance; Ribonucleases; Risk; Sampling; Sensitivity and Specificity; Sexually Transmitted Diseases; Silicon Dioxide; Slide; Small Business Innovation Research Grant; Specificity; Swab; Techniques; Temperature; Test Result; Testing; Time; Training; Trichomonas Infections; Trichomonas vaginalis; Urine; Vagina; Visit; amplification detection; bacterial resistance; base; cost; delivery complications; design; detection assay; detection method; drug-resistant gonorrhea; follow-up; genetic predictors; global health; health care settings; home test; innovation; isothermal amplification; laboratory equipment; laboratory experience; lateral flow assay; novel; pathogen; point of care; point-of-care diagnostics; prevent; prototype; rapid test; recombinase; screening; screening program; tool; urgent care

Project Summary Over 370 million people worldwide are infected with the sexually transmitted infections (STIs) chlamydia, gonorrhea, and trichomoniasis each year. While treatable, delayed treatment can have serious health problems, including infertility, disseminated infection, and pregnancy complications. Since fewer than half of at-risk individuals are screened for these common STIs, it is necessary to destigmatize STI testing and bring rapid point-of-care STI diagnostics to the developed and especially to the developing world, where over 75% of STI cases are thought to occur. Current nucleic acid-based STI tests offer optimal sensitivity and specificity but require laboratory infrastructure (electricity, refrigeration, and trained laboratory technicians) that is largely lacking where these STIs are most prevalent. These tests take days to return a result, which can result in loss of patient to follow-up and treatment. In addition, these tests fail to track the occurrence of antibiotic-resistant gonorrhea. With increases in azithromycin and ciprofloxacin resistance, and more frequent reports of cephalosporin resistance, multidrug- resistant gonorrhea could become a serious threat to global health, necessitating susceptibility testing and antibiotic stewardship. In this SBIR project, GoDx, Inc. proposes to develop a rapid, hand-held, low-cost, and sensitive point-of-care diagnostic to deliver rapid STI test results, which would simplify screening and allow for immediate treatment at the initial visit. To develop a rapid test for chlamydia, gonorrhea, and trichomoniasis, we will focus on innovations to integrate nucleic acid extraction, amplification, and detection to develop and test a prototype device by the end of Phase II. Our easy-to-use sample preparation device would require fewer than three user steps to purify nucleic acids for downstream detection. We will also reach benchmarks for the sensitive and specific amplification of genetic markers in Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis using an isothermal amplification technique followed by lateral flow detection. Our test will also amplify genetic predictors of antibiotic susceptibility to aid in the tracking and treatment of antibiotic resistant gonorrhea. Finally, we will integrate our assays into a test device delivering both STI and AMR test results in 30 minutes, with performance on par with laboratory-based STI tests. Our diagnostic tool will be simple and low-cost, making it ideal for use in the developing world where laboratory infrastructure is lacking, affordable for better screening programs worldwide, and easy enough for eventual in-home testing.

项目概要 全球有超过 3.7 亿人感染性传播感染 (STI) 每年都有衣原体、淋病和滴虫病。虽然可以治疗，但延迟治疗可能会 有严重的健康问题，包括不孕、播散性感染和怀孕 并发症。由于只有不到一半的高危人群接受了这些常见性传播感染的筛查， 有必要消除性传播感染检测的污名，并为人们提供快速的护理点性传播感染诊断 发达国家，尤其是发展中国家，超过 75% 的性传播感染病例被认为是 发生。目前基于核酸的 STI 检测可提供最佳的灵敏度和特异性，但需要 实验室基础设施（电力、制冷和训练有素的实验室技术人员） 这些性传播感染最流行的地方基本上缺乏。这些测试需要几天时间才能返回结果， 这可能会导致患者失去随访和治疗机会。此外，这些测试无法跟踪 抗生素耐药性淋病的发生。随着阿奇霉素和 环丙沙星耐药性、头孢菌素耐药性、多药耐药性的报道更为频繁 耐药性淋病可能对全球健康构成严重威胁，导致易感性 测试和抗生素管理。在这个 SBIR 项目中，GoDx, Inc. 提议开发一种快速、 手持式、低成本、灵敏的现场诊断，可提供快速的 STI 检测结果， 这将简化筛查并允许在初次就诊时立即进行治疗。发展 衣原体、淋病和滴虫病的快速检测，我们将重点关注创新 整合核酸提取、扩增和检测来开发和测试原型 设备在第二阶段结束时。我们易于使用的样品制备设备需要更少的 纯化核酸用于下游检测的用户步骤少于三个。我们也将达到 奈瑟菌遗传标记灵敏和特异性扩增的基准 使用等温灭菌器检测淋病、沙眼衣原体和阴道毛滴虫 扩增技术随后进行侧流检测。我们的测试还将放大遗传 抗生素敏感性预测因子，有助于追踪和治疗抗生素耐药性 淋病。最后，我们将把我们的检测集成到同时提供 STI 和 AMR 的测试设备中 30 分钟内即可得出测试结果，其性能与基于实验室的 STI 测试相当。我们的 诊断工具简单且成本低廉，非常适合在发展中国家使用 实验室基础设施缺乏，无法负担得起全球范围内更好的筛查项目，并且 对于最终的家庭测试来说足够简单。