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; 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.

项目摘要 全球超过3.7亿人感染了性传播感染（ETI） 每年的衣原体，淋病和毛瘤病。虽然可以治疗，延迟治疗可以 有严重的健康问题，包括不育，传播感染和怀孕 并发症。由于这些常见性传播感染的高危个人不到一半，因此 有必要对STI测试进行命令，并将快速护理STI诊断带到 尤其是对发展中国家的发展 发生。当前基于核酸的STI测试具有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） 在很大程度上缺乏这些性传播感染最普遍的地方。这些测试需要几天才能返回结果， 这可能导致患者失去随访和治疗。此外，这些测试无法跟踪 抗生素耐药性淋病的发生。阿奇霉素和 环丙沙星耐药性，以及头孢菌素耐药性的更频繁报告，多药 抵抗淋病可能成为对全球健康的严重威胁，需要易感性 测试和抗生素管理。在这个SBIR项目中，Godx，Inc。提议发展一个快速的， 手持，低成本和敏感的护理诊断，以提供快速的STI测试结果， 这将简化筛查，并在初次访问时立即进行治疗。发展 对衣原体，淋病和trichomonisis的快速测试，我们将专注于创新 整合核酸提取，扩增和检测以开发和测试原型 设备在第二阶段结束时。我们易于使用的样品准备设备需要更少 比三个用户步骤纯化核酸以进行下游检测。我们也将到达 奈瑟氏菌遗传标记敏感和特异性扩增的基准 淋病，衣原体沙眼和阴道的毛毛虫，使用等温 放大技术，然后进行横向流动检测。我们的测试还将扩大遗传 预测抗生素易感性以帮助跟踪和治疗抗生素耐药性 淋病。最后，我们将我们的测定法整合到提供STI和AMR的测试设备中 测试在30分钟内结果，并在基于实验室的STI测试中表现出色。我们的 诊断工具将是简单且低成本的，使其非常适合在发展中国家使用 缺乏实验室基础设施，负担得起全球更好的筛查计划，以及 足够容易实现最终的家庭测试。