Agreement between s-DRY and dr-WET for Xpert HPV results for all hrHPV and each HPV channel, overall and stratified on disease status, negative cytology, and LSIL or more severe diagnoses (LSIL+).

<p>Agreement between s-DRY and dr-WET for Xpert HPV results for all hrHPV and each HPV channel, overall and stratified on disease status, negative cytology, and LSIL or more severe diagnoses (LSIL+).</p

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

<div><p>Background</p><p>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).</p><p>Methods</p><p>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.</p><p>Results</p><p>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.</p><p>Conclusion</p><p>Self-collected vaginal dry swabs are a valid alternative to collecting cervical samples in PreservCyt solution for HPV testing with the Xpert HPV assay.</p><p>Impact</p><p>HPV self-collection with dry cotton swabs might assist in the implementation of an effective screening strategy in developing countries.</p><p>Trial registration</p><p>International Standard Randomized Controlled Trial Number Registry <a href="https://clinicaltrials.gov/ct2/show/DRKS00000584" target="_blank">ISRCTN83050913</a></p></div

Clinical performance of self-collection and physician-collection methods.

<p>Clinical performance of self-collection and physician-collection methods.</p

Sample sociodemographic characteristics and self-HPV assessment.

<p>Sample sociodemographic characteristics and self-HPV assessment.</p

Kaplan–Meier failure estimate showing the proportion of s-DRY and dr-WET invalid tests by length of delay.

<p>Kaplan–Meier failure estimate showing the proportion of s-DRY and dr-WET invalid tests by length of delay.</p

Flowchart of study participants.

<p>Abbreviations: dr-WET = physician-collected sample with swab immediately immersed in PreservCyt; s-DRY = Self-vaginal collection with dry swab. ASC-US = Atypical squamous cells of undetermined significance; ASC-H = Atypical squamous cells-cannot rule out high grade; LSIL = Low-grade squamous intraepithelial lesion; HSIL = High-grade squamous intraepithelial lesion; CIN1 = cervical intraepithelial neoplasia grade 1; CIN2 = cervical intraepithelial neoplasia grade 2; CIN3 = cervical intraepithelial neoplasia grade 3; CIN2+ = cervical intraepithelial neoplasia grade 2 or more severe. * Invalid results were excluded in the agreement analysis between dr-WET and s-DRY samples, as well as in the determination of clinical performance, using cobas results and histology (CIN2+), as reference standard.</p

Clinical performance of self-collection and physician-collection methods

<p>Abbreviations: CI = confidence interval; PPV = Positive Predictive Value; NPV = Negative Predictive Value; Dr-WET = physician-collected samples using specimen transport medium; s-DRY = self-collected samples using dry swab without transport medium; s-FTA = self-collected samples using a cytobrush applied to an FTA cartridge</p><p>*The p-value was calculated with McNemar's test.</p><p>Clinical performance of self-collection and physician-collection methods</p

Agreement and HPV positivity for each collection method, overall (n = 130) and according to cytology results (n = 119).

<p>Abbreviations: Dr-WET = physician-collected samples using specimen transport medium; n = number; NILM = Negative for intraepithelial lesion or malignancy; ASC-US = Atypical squamous cells of undetermined significance; ASC-H = Atypical squamous cells-cannot rule out high grade; AGC = Atypical glandular cell; LSIL = Low-grade squamous intraepithelial lesion; LSIL+ = Low-grade squamous intraepithelial lesion or worse; HSIL = High-grade squamous intraepithelial lesion; CC = Cervical cancer; CI = confidence interval; PPA = Proportion of Positive Agreement.</p><p>*Comprises results from Self-HPV using both collection methods (s-DRY and s-FTA).</p><p>Agreement and HPV positivity for each collection method, overall (n = 130) and according to cytology results (n = 119).</p

Sample sociodemographic characteristics (n = 130).

<p>Abbreviations: IQR = Interquartile range N. = number; SD = standard deviation; y = years.</p><p>Sample sociodemographic characteristics (n = 130).</p

Comparison between number of oncogenic HPV genotypes^* detected in the three different samples (s-FTA vs. Dr-WET; s-FTA vs. s-DRY; s-DRY vs. Dr-WET).

<p>Abbreviations: n. = number; Dr-WET = physician-collected samples using specimen transport medium; s-DRY = self-collected samples using dry swab without transport medium; s-FTA = self-collected samples using a cytobrush applied to an FTA cartridge</p><p>*Oncogenic genotypes include types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 73, 82 (Seegene, Anyplex^™ II HPV28)</p><p>Comparison between number of oncogenic HPV genotypes^{<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0143644#t006fn002" target="_blank">*</a>} detected in the three different samples (s-FTA vs. Dr-WET; s-FTA vs. s-DRY; s-DRY vs. Dr-WET).</p