Trial reportExpert review of molecular diagnostics2017
Clinical performance of the Solana® Point-of-Care Trichomonas Assay from clinician-collected vaginal swabs and urine specimens from symptomatic and asymptomatic women.
Trial report in Expert review of molecular diagnostics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Sexually Transmitted Infections Treatment Guidelines, 2021.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2021Guideline
- Vaginal Swab vs Urine for Detection ofAnnals of family medicinePooled it
- Diagnosis and Management of Trichomonas vaginalis: Summary of Evidence Reviewed for the 2021 Centers for Disease Control and Prevention Sexually Transmitted Infections Treatment Guidelines.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Trial
- Optimal Timing for Trichomonas vaginalis Test of Cure Using Nucleic Acid Amplification Testing.Sexually transmitted diseases · 2019Trial
- Isothermal nucleic acid amplification techniques: A comprehensive overview on their principle & applications as alternative to PCR.Practical laboratory medicine · 2026Review
- Trichomoniasis and Other Sexually Transmitted Parasitic Diseases in Women.Clinical obstetrics and gynecology · 2025Review
- The Past, Present, and Future in the Diagnosis of a Neglected Sexually Transmitted Infection: Trichomoniasis.Pathogens (Basel, Switzerland) · 2024Review
- Isothermal nucleic acid amplification and its uses in modern diagnostic technologies.3 Biotech · 2023Review
- Trichomoniasis.Infectious disease clinics of North America · 2023Review
- Meta-analysis of the correlation between vaginal microenvironment and HPV infection.American journal of translational research · 2023Review
- Bridging the gap between development of point-of-care nucleic acid testing and patient care for sexually transmitted infections.Lab on a chip · 2022Review
- Article
- Point-of-Care Testing for Sexually Transmitted Infections: A Review of Recent Developments.Archives of pathology & laboratory medicine · 2020Review
- Current and Future Perspectives on Isothermal Nucleic Acid Amplification Technologies for Diagnosing Infections.Infection and drug resistance · 2020Review
- Recent advances in the epidemiology, diagnosis, and management ofF1000Research · 2019Review
- Helicase-dependent isothermal amplification: a novel tool in the development of molecular-based analytical systems for rapid pathogen detection.Analytical and bioanalytical chemistry · 2018Review
- Rapid and point-of-care tests for the diagnosis ofSexually transmitted infections · 2017Review
- Strategies for Prevention and Treatment of Trichomonas vaginalis Infections.Clinical microbiology reviews · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
backgroundSolana® (Quidel) is a new rapid (<40 min.) point-of-care (POC) test for qualitative detection of Trichomonas vaginalis (TV) DNA. The assay has two steps: 1) specimen preparation, and 2) amplification and detection using isothermal Helicase-Dependent Amplification (HDA). The objective was to demonstrate the performance of Solana for vaginal swabs and female urines based on comparison to wet mount and TV culture. Performance was also compared to the Aptima-TV assay.
methodsUrine and four clinician-collected vaginal swabs were collected. The first two were used for FDA composite reference (wet mount; InPouch TV Culture). The third swab was used for Solana. Sensitivity/specificity were based on the reference method. A specimen was considered positive if either test was positive. The fourth swab was for Aptima-TV.
resultsVaginal swabs and urines were obtained from 501 asymptomatic and 543 symptomatic women. Prevalence of TV by was 11.5%. For swabs, Solana® demonstrated high sensitivity and specificity from asymptomatic (100%/98.9%) and symptomatic (98.6%/98.5%) women, as well as for urines from asymptomatic (98.0%/98.4%) and symptomatic (92.9%/97.9%) women, compared to the reference method. Compared to Aptima-TV, the sensitivity/specificity was 89.7%/99.0% for swabs and 100%/98.9% for urines.
conclusionThe Solana® assay performed well compared to the reference assays.
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