Format

Send to

Choose Destination
PLoS One. 2017 Jul 27;12(7):e0181905. doi: 10.1371/journal.pone.0181905. eCollection 2017.

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

Author information

1
Division of Gynaecology, Department of Gynaecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.
2
Geneva Foundation for Medical Education and Research, Geneva, Switzerland.
3
Biopath Lab SA, Lausanne, Switzerland.

Abstract

BACKGROUND:

Polymerase 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).

METHODS:

In 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.

RESULTS:

HPV 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.

CONCLUSION:

Self-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 REGISTRATION:

International Standard Randomized Controlled Trial Number Registry ISRCTN83050913.

PMID:
28750015
PMCID:
PMC5547698
DOI:
10.1371/journal.pone.0181905
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Public Library of Science Icon for PubMed Central
Loading ...
Support Center