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 滴虫病，一种由原生动物阴道毛滴虫引起的可治愈性传播疾病 (STD) （电视），估计是全世界最常见的非病毒性病。在美国，估计有 3.7 百万人感染，超过衣原体和淋病的总和。 尽管只有大约 30% 的人出现任何症状，但那些没有症状的人仍然可以感染其他人。 未经治疗的电视感染可能会导致盆腔炎、不孕症和宫颈癌等严重后果 癌症。由于电视感染的患病率很高，疾病预防控制中心建议对所有寻求阴道护理的女性进行检测 除了对以下人员进行筛查外，还对所有无症状艾滋病毒呈阳性的妇女进行出院和常规筛查 感染风险高或处于高流行环境中。然而，虽然核酸扩增测试（NAAT）进行 尿液或生殖器拭子样本的检测已成为电视诊断的护理标准（CDC 指南）， 目前还没有可以在护理点 (POC) 进行的快速、廉价的 TV NAAT。 一种廉价、快速、适用于电视的 POC NAAT，在尿液和阴道拭子样本上均表现良好， 对临床决策产生直接影响。在 POC 进行快速检测将增加治疗效果 通过在初次就诊时提供结果来进行治疗，从而制定治疗方案。 POC NAAT 具有高 尿液和阴道拭子样本的敏感性将比现有技术提供明显的诊断优势 快速抗原检测测试（仅批准用于拭子）和当前的 TV NAAT（仅在集中中心提供） 实验室设置）。 在这里，我们建议开发一种能够检测 TV 的高灵敏度和特异性的纸流控 NAAT 平台 尿液和拭子样本，并使用波士顿的临床样本提供初步性能数据 儿童医院 (BCH) 之前已通过自动化 NAAT (APTIMA) 测试。我们将开发双模块 纸流体装置利用我们创新的样品浓缩技术来丰富 电视瞄准并提高我们的敏感性。通过在第一个模块中浓缩输入的尿液样本，然后进行分析 第二个下游 NAAT 模块中的浓缩样品，我们的目标是降低检测限 并提高电视测定的灵敏度。我们的最终目标是创建一种快速、廉价的电视测试 灵敏度和特异性与自动化 NAAT 类似，但可以在 POC 中实施。这部作品有 有可能导致我们筛查和管理电视疾病的方式发生范式转变。

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