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.ImpactHPV 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
Highlights
In recent years, the development of high-risk human papillomavirus (HPV) tests has created an important change in our approach to cervical cancer (CC) screening
Good agreement was found between HPV self-collection using a dry swab (s-DRY) and physician-collected sample using PreservCyt (dr-WET) samples (kappa±Standard error (SE) = 0.64 ±0.09,), for low-grade squamous intraepithelial lesions (LSIL+)
Self-collected vaginal dry swabs are a valid alternative to collecting cervical samples in PreservCyt solution for HPV testing with the Xpert HPV assay
Summary
The development of high-risk (hr) human papillomavirus (HPV) tests has created an important change in our approach to cervical cancer (CC) screening. Developed countries are progressively incorporating HPV testing into their national screening programs and updating their current guidelines [3]. The introduction of a rapid point-of-care non-batch assay, which facilitates same-day screen and management strategies, is essential in developing countries, especially for screenand-treat strategies. This approach minimizes the need for repeated visits, encouraging greater numbers of eligible women to participate in the program. Real-time polymerase chain reaction (PCR)-based hrHPV tests with a high analytic sensitivity are preferable to ensure similar accuracy between clinician- and self-collected samples [7]
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