A paperfluidic molecular diagnostic for Trichomonas vaginalis

阴道毛滴虫的纸流体分子诊断

• 批准号: 9767015
• 负责人: Mario Cabodi
• 金额: $ 20.93万
• 依托单位: BOSTON UNIVERSITY (CHARLES RIVER CAMPUS)
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-20 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9767015
• 关键词: Age; Antigens; Bedside Testings; Benchmarking; Biological Assay; Boston; Centers for Disease Control and Prevention (U.S.); Chlamydia; Chlamydia trachomatis; Clinic; Clinical; Contracts; Cystitis; DNA Probes; Data; Detection; Devices; Diagnosis; Diagnostic; Disease; Epidemiology; Genital system; Goals; Gold; Gonorrhea; Guidelines; HIV; HIV Infections; HIV Seropositivity; High Prevalence; Imprisonment; Individual; Infection; Infertility; Laboratories; Lateral; Lead; Low Birth Weight Infant; Malignant neoplasm of cervix uteri; Manuals; Metronidazole; Neonatal; Not Hispanic or Latino; Nucleic Acids; Organism; Patients; Pediatric Hospitals; Pelvic Inflammatory Disease; Performance; Persons; Pregnant Women; Premature Birth; Prevalence; Provider; Risk; Sampling; Sensitivity and Specificity; Sexually Transmitted Diseases; Specificity; Specimen; Subgroup; Swab; Symptoms; Techniques; Testing; Time; Tinidazole; Trichomonas Infections; Trichomonas vaginalis; United States; Urethritis; Urine; Vagina; Vaginal Discharge; Vaginitis; Visit; Visual; Woman; Work; care seeking; clinical decision-making; co-infection; health disparity; high efficiency particulate air filter; high risk; improved; infection risk; innovation; men; molecular diagnostics; pathogen; patient screening; point of care; routine screening; screening; screening guidelines; standard of care; transmission process

Summary/Abstract Trichomoniasis, a curable sexually-transmitted disease (STD) caused by the protozoan Trichomonas vaginalis (TV), is estimated to be the most common non-viral STD world-wide. In the United States, an estimated 3.7 million people have the infection, more than chlamydia and gonorrhea combined. Although only about 30% develop any symptoms, those who do not have symptoms can still infect others. Untreated TV infection can lead to severe consequences like pelvic inflammatory disease, infertility, and cervical cancer. Due to high prevalence of TV infection, the CDC recommends testing all women seeking care for vaginal discharge and routine screening in all asymptomatic HIV-positive women, in addition to screening in persons at high risk for infection or in high-prevalence settings. However, while nucleic amplification tests (NAAT) performed on urine or genital swab specimens have become standard of care for TV diagnosis (CDC guideline), there currently are no rapid, inexpensive TV NAATs that can be performed at the point-of care (POC). An inexpensive, rapid, POC NAAT for TV that performed well on both urine and vaginal swab samples would have an immediate impact on clinical decision making. A rapid test performed at POC would increase treatment rates by delivering the results at the initial visit, allowing treatment to be prescribed. A POC NAAT with high sensitivity in both urine and vaginal swab samples would provide distinct diagnostic advantages over existing rapid antigen detection tests (approved for swabs only) and current TV NAATs (available only in centralized laboratory settings). Here, we propose to develop a highly sensitive and specific paperfluidic NAAT platform capable of detecting TV in urine and swab samples, and provide preliminary performance data using clinical specimens from Boston Children’s Hospital (BCH) previously tested by automated NAAT (APTIMA). We will develop a dual-module paperfluidic device that leverages our innovative sample concentration technique to enrich the concentration of TV targets and improve our sensitivity. By concentrating the input urine sample in the first module then assaying the concentrated sample in the second, downstream NAAT module, we aim to decrease the limit of detection of and increase the sensitivity of the TV assay. Our ultimate goal is to create a rapid, and inexpensive TV test with sensitivity and specificity similar to that of automated NAAT, but that can be implemented at POC. This work has the potential to lead to a paradigm shift in how we screen for, and thus manage, TV disease.

摘要/摘要 Trichomoniasis，一种由原生动物Trichomonas阴道引起的可治愈的性传播疾病（STD） （电视）估计是全球最常见的非病毒性病。在美国，估计3.7 百万人患有感染，超过衣原体和淋病的总和。 尽管只有大约30％的人开发任何符号，但没有符号的人仍然可以感染其他符号。 未经治疗的电视感染会导致严重的后果，例如骨盆炎症性疾病，不育症和宫颈疾病 癌症。由于电视感染的高患病率，CDC建议测试所有寻求阴道护理的妇女 除了筛查在所有不对称的HIV阳性妇女中的出院和常规筛查，除了筛查 高风险感染或高价值环境。但是，进行核扩增测试（NAAT） 关于尿液或生殖拭子标本已成为电视诊断标准（CDC指南） 目前，可以在医疗点（POC）进行快速，廉价的电视NAAT。 在尿液和阴道样品上表现良好的电视廉价，快速，POC NAAT将会 对临床决策有直接影响。在POC进行快速测试将增加治疗 通过在初次访问时交付结果的费率，从而可以开处方。一个高的POC NAAT 尿液和阴道拭子样品的敏感性都将在现有 快速抗原检测测试（仅批准签名）和当前的电视NAATS（仅在集中式中可用 实验室环境）。 在这里，我们建议开发一个高度敏感和特定的纸张NAAT平台，能够检测电视 在尿液和拭子样品中，并使用波士顿的临床标本提供初步性能数据 以前由自动化NAAT（APTIMA）测试的儿童医院（BCH）。我们将开发一个双模块 利用我们创新样品浓度技术的纸张流体设备丰富了浓度 电视目标并提高我们的敏感性。通过将输入尿液样本集中在第一个模块中，然后分析 在第二个下游NAAT模块中，集中样品，我们旨在降低检测的极限 并提高电视分析的灵敏度。我们的最终目标是通过使用 敏感性和特异性类似于自动化NAAT的敏感性和特异性，但可以在POC上实现。这项工作有 导致我们筛查电视疾病并因此管理电视疾病的范式转变的潜力。

项目成果

Rapid electrostatic DNA enrichment for sensitive detection of Trichomonas vaginalis in clinical urinary samples.

• DOI: 10.1039/c9ay02478f
• 发表时间: 2020-02-28
• 期刊: Analytical methods : advancing methods and applications
• 作者: Rosenbohm JM;Robson JM;Singh R;Lee R;Zhang JY;Klapperich CM;Pollock NR;Cabodi M
• 通讯作者: Cabodi M