Dry Storage and Transport of a Cervicovaginal Self-Sample by Use of the Evalyn Brush, Providing Reliable Human Papillomavirus Detection Combined with Comfort for Women

Abstract

dPrimary screening using high-risk human papillomavirus (hrHPV) detection has been suggested as a way of improving cervical cancer prevention. Women currently not attending screening (nonresponders) are more likely to participate when given the opportunity of self-sampling for hrHPV testing. The Evalyn Brush is a new cervicovaginal self-sampling device, developed specifically to meet women's demands, which is user-friendly and easy to use. The aims of this study were to investigate agreement of hrHPV detection by two PCR methods between the Evalyn Brush and physician-obtained samples and to study women's acceptance of this self-sampling device. Each of 134 women visiting the gynecology outpatient clinic collected a self-obtained sample (self-sample) and completed a questionnaire. The brush was stored dry. After self-sampling, a trained physician obtained a conventional cervical cytology specimen in ThinPrep medium. HrHPV detection was performed using the SPF 10 -DEIA-LiPA 25 and GP5؉/6؉-LQ-test. The overall agreement for hrHPV detection using SPF 10 -DEIA-LiPA 25 between the self-sample and the physician-taken sample was 85.8% (kappa value, 0.715; 95% confidence interval [CI], 0.597 to 0.843; P ‫؍‬ 1.000). The overall agreement for hrHPV detection using GP5؉/6؉-LQ between the self-sample and the physician-taken sample was 86.6% (kappa value, 0.725; 95% CI, 0.607 to 0.843; P ‫؍‬ 0.815). Ninety-eight percent of the women rated their experience as good to excellent. Moreover, 95% of women preferred self-sampling to physician sampling. Self-sampling using the dry Evalyn Brush system is as good as a physician-taken sample for hrHPV detection and is highly acceptable to women. To validate this self-sampling device for clinical use, a large screening cohort should be studied. C ervical cytology screening programs have significantly decreased the incidence and mortality of cervical cancer. Primary screening using high-risk human papillomavirus (hrHPV) detection has been found to be more sensitive than conventional cervical cytology for detecting cervical precancer (11,34,41,42). All data argue for the implementation of hrHPV testing as a primary test in cervical cancer screening, and the Health Council in the Netherlands has advised the Minister of Health to implement primary screening with hrHPV detection as a way of improving cervical cancer prevention (24).Cervical cancer incidence is higher among women who do not respond (nonresponders) or have no access to cervical screening programs than in screened women. A substantial number of nonresponders participate in screening when given the opportunity of self-sampling for hrHPV testing (1, 19). Self-sampling for hrHPV therefore has the potential to reduce cervical cancer incidence, especially among nonresponders (5).Cervicovaginal self-collected samples (self-samples) have proved to be as reliable as physician-obtained cervical samples for the detection of hrHPV (9, 22, 37-39, 44-45, 50). Studies on HPV selfsampling have used a great variety of collection devices, such a...

Cervicovaginal HPV Infection in Female Renal Transplant Recipients: An Observational, Self-Sampling Based, Cohort Study

“…It may be argued that, due to its low threshold values, this test cannot discriminate between active and latent infections, and has therefore a lower specificity for clinically relevant infections. However, in contrast to the recently shown lower pooled sensitivity of HPV-testing on self-collected samples for detecting CIN2 or worse compared to testing on a clinician based sample, SPF 10 -LiPA PCR based hrHPV detection on self-collected samples approaches the sensitivity and specificity of clinician-taken samples (9,33,34). Therefore, using the SPF 10 -LiPA PCR seems a valuable strategy in HPV-based screening on selfcollected specimens.…”

“…All participants were asked to self-collect a cervicovaginal sample in the privacy of their own home with the dry Evalyn Brush 1 system (Rovers Medical Devices B.V., Oss, The Netherlands), which was proven to provide similar results as a physician-taken sample for high risk HPV (hrHPV) detection (9). Patients received the collection device, written instructions with illustrations and a return package comprising a leak proof seal bag, absorption sheet and a plastic return envelope complying with the packing instruction for the sending of biological substances (category B) per mail.…”

“…A number of studies showed that there is a high level of concordance between the results obtained with self-collected samples and physician collected samples (9)(10)(11)(12). Self-sampling is easy to use, inexpensive and highly accepted by women.…”

Self-Collection Tools for Routine Cervical Cancer Screening: A Review

“…The self-collected samples from Evalyn brush shows 85.5% agreement for high risk HPV detection when compared to physician-taken samples (van Baars et al, 2012). In addition, the pink colour of Evalyn brush is attractive to women.…”

“…It can be used for dry transport and storage (van Baars et al, 2012). Brushes are flexible and easy to use, can be processed in the same way as physician-obtained smears, and are suitable for sending by mails (Schmeink et al, 2011).…”