A paperfluidic molecular diagnostic for Trichomonas vaginalis

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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.