Evidence map›Paper›PMID 28750015›Full record

Trial reportPloS one2017

Accuracy of self-collected vaginal dry swabs using the Xpert human papillomavirus assay.

Rosa Catarino, Pierre Vassilakos, Aline Bilancioni, Stéphanie Bougel, Meriem Boukrid, Ulrike Meyer-Hamme, Patrick Petignat

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

7 authors.

Rosa CatarinoDivision of Gynaecology, Department of Gynaecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.ORCID http://orcid.org/0000-0002-5317-7710
Pierre VassilakosGeneva Foundation for Medical Education and Research, Geneva, Switzerland.
Aline BilancioniDivision of Gynaecology, Department of Gynaecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.
Stéphanie BougelBiopath Lab SA, Lausanne, Switzerland.
Meriem BoukridDivision of Gynaecology, Department of Gynaecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.
Ulrike Meyer-HammeDivision of Gynaecology, Department of Gynaecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.
Patrick PetignatDivision of Gynaecology, Department of Gynaecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPolymerase chain reaction-based Xpert human papillomavirus (HPV) assay is a rapid test that detects high-risk HPV (hrHPV) infection. This point-of-care test is usually performed by collecting a cervical specimen in a vial of PreservCyt® transport medium. We compared HPV test positivity and accuracy between self-collected sample with a dry swab (s-DRY) versus physician-collected cervical sampling using a broom like brush and immediate immersion in PreservCyt (dr-WET).

methodsIn this cross-sectional study, we recruited 150 women ≥ 18 years old attending the colposcopy clinic in the University Hospital of Geneva. Each participant first self-collected a vaginal sample using a dry swab and then the physician collected a cervical specimen in PreservCyt. HPV analysis was performed with Xpert. Part of the PreservCyt-collected sample was used for hrHPV detection with the cobas® HPV test. HPV test positivity and performance of the two collection methods was compared.

resultsHPV positivity was 49.1% for s-DRY, 41.8% for dr-WET and 46.2% for cobas. Good agreement was found between s-DRY and dr-WET samples (kappa±Standard error (SE) = 0.64±0.09,), particularly for low-grade squamous intraepithelial lesions (LSIL+) (kappa±SE = 0.80±0.17). Excellent agreement was found between the two samples for HPV16 detection in general (kappa±SE = 0.91±0.09) and among LSIL+ lesions (kappa±SE = 1.00±0.17). Sensitivities and specificities were, respectively, 84.2% and 47.1%(s-DRY), 73.1% and 58.7%. (dr-WET) and 77.8% and 45.7% (cobas) for CIN2+ detection. The median delay between sampling and HPV analysis was 7 days for the Xpert HPV assay and 19 days for cobas. There were 36 (24.0%) invalid results among s-DRY samples and 4 (2.7%) among dr-WET (p = 0.001). Invalid results happened due to the long interval between collection and analysis.

conclusionSelf-collected vaginal dry swabs are a valid alternative to collecting cervical samples in PreservCyt solution for HPV testing with the Xpert HPV assay. IMPACT: HPV self-collection with dry cotton swabs might assist in the implementation of an effective screening strategy in developing countries.

trial registrationInternational Standard Randomized Controlled Trial Number Registry ISRCTN83050913.

Indexed as

AdolescentAdultAgedFemaleHumansKaplan-Meier EstimateMiddle AgedPapillomaviridaePapillomavirus InfectionsSpecimen HandlingVaginal SmearsYoung Adult

Identifiers

PMID28750015
PMCPMC5547698

What OpenQuestion holds

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Registered trials

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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.