Evidence map›Paper›PMID 40214249›Full record

ArticleJournal of clinical microbiology2025

Diagnostic accuracy of the Daye diagnostic tampon compared to clinician-collected and self-collected vaginal swabs for detecting HPV: a comparative study.

Valentina Milanova, Michelle Gomes, Kalina Mihaylova, John Luke Twelves, Jan Multmeier, Hana McMahon, Hannah McCulloch, Kate Cuschieri

Abstract readComparative Study
In one paragraph

Article in Journal of clinical microbiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Review
  2. 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

8 authors.

Valentina MilanovaDaye, London, United Kingdom.
Michelle GomesDaye, London, United Kingdom.ORCID 0009-0004-5362-229X
Kalina MihaylovaDaye, London, United Kingdom.
John Luke TwelvesLindus Health, London, United Kingdom.
Jan MultmeierTotaEffects GmH, Oranienburg, Germany.
Hana McMahonCenter for Reproductive Health, University of Edinburgh, Edinburgh, Scotland, United Kingdom.
Hannah McCullochIndependent consultant, London, United Kingdom.ORCID 0000-0001-5006-967X
Kate CuschieriCenter for Reproductive Health, University of Edinburgh, Edinburgh, Scotland, United Kingdom.ORCID 0000-0002-2604-3928

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cervical cancer screening is vital for achieving global elimination of this preventable disease. Vaginal self-sampling (VSS) for human papillomavirus (HPV) has the potential to increase screening uptake, particularly among individuals who may be underserved by clinician collection. Expanding self-sampling options with accurate, acceptable collection devices is essential. The Daye diagnostic tampon (DDT) offers an innovative approach, utilizing a tampon for HPV-based detection. This study assessed the diagnostic accuracy of DDT in detecting high-risk HPV infections, using vaginal clinician-collected swabs (CCS) as the reference standard. In this UK-based study, 260 participants provided CCS and VSS (with Copan FLOQSwabs) and DDT samples for HPV testing. Samples were analyzed using the Aptima HPV assay, which detects 14 high-risk HPV types. The sensitivity, specificity, positive predictive value, and negative predictive value of the DDT were evaluated against the CCS. Invalidity rates-HPV-negative results with negative internal controls-were compared across sampling methods. The DDT showed a sensitivity of 82.9% [95% confidence interval (CI): 72.4%-89.9%], specificity of 91.6% (CI: 86.4%-94.9%), and overall accuracy of 89.0% (CI: 84.4%-92.4%) relative to CCS. McNemar's test showed no significant difference between CCS and DDT results (

Indexed as

Early Detection of CancerMenstrual Hygiene ProductsPapillomavirus InfectionsUterine Cervical NeoplasmsVaginaVaginal SmearsAdultAgedFemaleHumansMiddle AgedPapillomaviridaePredictive Value of TestsProspective StudiesReproducibility of ResultsSelf Carecervical cancer screeningdiagnostic tamponHPVHPV home testinghuman papillomavirusself-sampling for HPVself-sampling for human papillomavirusself-testing for HPV

Identifiers

PMID40214249
PMCPMC12077143

What OpenQuestion holds

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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.