ArticleThe Lancet. Infectious diseases2021
Performance of a single-use, rapid, point-of-care PCR device for the detection of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis: a cross-sectional study.
Article in The Lancet. Infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 3 of them syntheses that pooled it.
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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.
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Who cites it
45 citing papers in PubMed, 3 syntheses or guidelines pooled it, 103 citations in OpenAlex.
- Point-of-care Tests for Chlamydia trachomatis and Neisseria gonorrhoeae: Review of the Literature.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Pooled it
- Sex disparities in chlamydia and gonorrhea treatment in U.S. adult emergency departments: A systematic review and meta-analysis.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2025Pooled it
- Pooled it
- Association between sexually transmitted infections and reproductive lifespan: analysis of the NHANES 1999-2023.BMC public health · 2026Article
- Current and Emerging Approaches and Technologies for Rapid Detection of Neisseria gonorrhoeae Antimicrobial Resistance.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Review
- Review
- Real-world Use of Molecular Point-of-care Testing for Sexually Transmitted Infections (STIs) in the Emergency Department: Why It Matters for Acute Care Management.Open forum infectious diseases · 2026Article
- The evolution of diagnostic microbiology: integrating culture-based methods and genomic advances.PeerJ · 2026Review
- Molecular Diagnosis ofJournal of tropical medicine · 2026Review
- Sensitivity and specificity of the Cobas Liat CT/NG/MG nucleic acid test in a clinical laboratory setting and point-of-care location.Journal of clinical microbiology · 2025Observational
- Molecular characterization and high prevalence ofVeterinary world · 2025Article
- [Point-of-care tests for sexually transmitted infections-what is the current status?]Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2025Article
- A low-cost point-of-care device for the simultaneous detection of two sexually transmitted bacterial pathogens in vaginal swab samples.The Analyst · 2025Article
- Trichomoniasis and Other Sexually Transmitted Parasitic Diseases in Women.Clinical obstetrics and gynecology · 2025Review
- Diagnostic accuracy of real-time polymerase chain reaction assay for the detection ofAfrican journal of laboratory medicine · 2025Review
- Syndromic and biological screening for sexually transmitted infections in female sex workers in Côte d'Ivoire: the ANRS 12381 PRINCESSE cohort study.Frontiers in public health · 2025Article
- Global burden of trichomoniasis: current status, trends, and projections (1990-2021).Frontiers in public health · 2025Article
- Syndromic management of sexually transmitted infections among female sex workers in Lomé (Togo), 2023.PloS one · 2025Article
- Article
- Current and emerging strategies to curb antibiotic-resistant urinary tract infections.Nature reviews. Urology · 2024Review
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Authors and funding
16 authors at 12 institutions in 1 country.
Funding
Abstract
backgroundTimely detection and treatment are important for the control of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The objective of this study was to measure the performance of the Visby Medical Sexual Health Test, a single-use, point-of-care PCR device.
methodsWomen aged 14 years and older who presented consecutively to ten clinical sites across seven US states were enrolled for a cross-sectional, single-visit study. Patients who consented to participate, and who had not used any exclusionary products in the genital area in the previous 48 h, provided self-collected vaginal swabs for testing with the investigational device. Untrained operators received the specimens and ran the device using the guide provided. Specimens had to be run within 2 h of collection to be considered valid. For comparison, patient-infected status was derived by testing clinician-collected vaginal specimens with the Hologic Aptima Combo 2 Assay and Aptima Trichomonas vaginalis Assay, as well as the BD ProbeTec CT/GC Q
findingsBetween Feb 25, 2019, and Jan 6, 2020, 1585 participants aged between 14 years and 80 years (mean 34·8 [SD 14·2]) were enrolled. 1555 participants had tests run with the investigational device, of whom 1532 (98·5%) had a valid result on either the first or repeat test. Among the patients with evaluable results (including a determinate patient-infected status), the device had a sensitivity of 97·6% (95% CI 93·2-99·2) and specificity of 98·3% (97·5-98·9) for C trachomatis (n=1457), sensitivity of 97·4% (86·5-99·5) and specificity of 99·4% (98·9-99·7) for N gonorrhoeae (n=1468), and sensitivity of 99·2% (95·5-99·9) and specificity of 96·9% (95·8-97·7) for T vaginalis (n=1449).
interpretationThis innovative, rapid, easy-to-use, single-use, point-of-care device to detect C trachomatis, N gonorrhoeae, and T vaginalis infections showed excellent sensitivity and specificity, and could represent an important advance in the development of rapid diagnostics for sexually transmitted infections and other infectious diseases.
fundingDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.