Evidence map›Paper›PMID 27196258›Full record

ArticleSexually transmitted diseases2016

Rapid Diagnosis of Trichomonas vaginalis by Testing Vaginal Swabs in an Isothermal Helicase-Dependent AmpliVue Assay.

Charlotte A Gaydos, Marcia Hobbs, Jeanne Marrazzo, Jane Schwebke, Jenell S Coleman, Billie Masek, Laura Dize, Dan Jang, Jenny Li, Max Chernesky

Open access · greenAbstract readEvaluation Study
In one paragraph

Article in Sexually transmitted diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 11% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Sexually Transmitted Infections Treatment Guidelines, 2021.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2021
    Guideline
  2. Trial
  3. Molecular Diagnosis ofJournal of tropical medicine · 2026
    Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Trichomoniasis.Infectious disease clinics of North America · 2023
    Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Current and Future Trends in the Laboratory Diagnosis of Sexually Transmitted Infections.International journal of environmental research and public health · 2021
    Review
  14. Article
  15. Review
  16. Rapid and point-of-care tests for the diagnosis ofSexually transmitted infections · 2017
    Review
  17. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Charlotte A GaydosFrom the *Division of Infectious Diseases, The Johns Hopkins University, Baltimore, MD; †Division of Infectious Diseases, University of North Carolina, Chapel Hill, NC; ‡Division of Infectious Diseases, University of Washington, Seattle, WA; §Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL; and ¶Division of Infectious Diseases, St. Joseph's Healthcare/McMaster University, Hamilton, Ontario, Canada.
Marcia Hobbs
Jeanne Marrazzo
Jane Schwebke
Jenell S Coleman
Billie Masek
Laura Dize
Dan Jang
Jenny Li
Max Chernesky
Office of Infectious Diseases · US

Funding

LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
TrainingU54EB007958 · NIBIB · JOHNS HOPKINS UNIVERSITY · PI Yukari C Manabe, Susan Anne Tuddenham · 2007 to 2026
$34.6M
NIAID NIH HHS UM1 AI068613NIBIB NIH HHS U54 EB007958
6 · The paper itself

Abstract

backgroundThe AmpliVue Trichomonas Assay (Quidel) is a new Federal Drug Administration-cleared rapid test for qualitative detection of Trichomonas vaginalis (TV) DNA in female vaginal specimens. The assay is based on BioHelix's helicase-dependent amplification isothermal technology in conjunction with a disposable lateral-flow detection device, with a total turnaround time of approximately 45 minutes.

objectiveThe objective of this study was to compare the performance of this new assay to wet preparation and culture as well as to another Federal Drug Administration-cleared nucleic acid amplification assay.

methodsFour clinician collected vaginal swabs were obtained from women attending sexually transmitted disease, family planning, and OB/GYN clinics and tested by AmpliVue Trichomonas Assay and comparator tests: saline microscopy, TV culture (InPouch), and Aptima TV. AmpliVue Trichomonas Assay results were compared with a composite positive comparator (CPC) as determined by the results from culture and/or wet mount microscopic examination. At least one of either the wet preparation or culture reference test results was required to be positive to establish CPC.

resultsA total of 992 patients, 342 symptomatic and 650 asymptomatic patients, were included in the study. Results for AmpliVue for all women combined compared with saline microscopy and culture as a CPC yielded a sensitivity of 100%. Specificity for all women was 98.2%. Overall percent agreement versus Aptima TV was 97.8%. Sensitivity for AmpliVue compared with Aptima was 90.7% %, whereas specificity was 98.9%.

conclusionsThe rapid AmpliVue Trichomonas Assay performed as well as microscopy and culture, and had comparable sensitivity and specificity to another nucleic acid amplification test for the detection of TV. This study provided evidence of new diagnostic options and indicated very good performance of amplified testing for detection of TV in symptomatic and asymptomatic women.

Indexed as

AdolescentAdultFemaleHumansMicroscopyNucleic Acid Amplification TechniquesSensitivity and SpecificitySexually Transmitted DiseasesTrichomonas vaginalisTrichomonas VaginitisVaginaYoung Adult

Identifiers

PMID27196258
PMCPMC4874652
OpenAlexW2406850495

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.