Dataset Information

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

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.

SUBMITTER: Catarino R

PROVIDER: S-EPMC5547698 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Publications

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

Catarino Rosa R Vassilakos Pierre P Bilancioni Aline A Bougel Stéphanie S Boukrid Meriem M Meyer-Hamme Ulrike U Petignat Patrick P

PloS one 20170727 7

<h4>Background</h4>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).<h4>Method ...[more]

PMID: 28750015

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Dataset Information

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

Background

Methods

Results

Conclusion

Impact

Trial registration

Publications

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

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