Women in the Netherlands Prefer Self-Sampling With a Novel Lavaging Device to Clinician Collection of Specimens for Cervical Cancer Screening

Jones, Heidi E.; Wiegerinck, M.A.H.M.; Nieboer, Theodoor E.; Mol, Ben Willem; Westhoff, Carolyn

doi:10.1097/olq.0b013e3181812cf0

Cited by 20 publications

(34 citation statements)

References 8 publications

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“…Our results indicate that self-sampling using the dry Evalyn Brush system is as good as a physician-taken smear for hrHPV detection. Our results are in line with previous studies showing repeatedly that self-collected cervicovaginal samples are as reliable as clinician-collected specimens for hrHPV detection (9,12,19,26,28,(37)(38)(39)44). Previous HPV self-sampling studies have used a variety of collection devices and HPV DNA tests.…”

Section: Discussionsupporting

confidence: 82%

“…The few women in our study who preferred clinician sampling specified their main reason as fear of inadequate self-sampling. This is in line with findings of previous studies (14,23,28,40,49). Acceptability of the self-sampling device may be important for women who ignore the invitation to attend the national cervical cancer screening program or in settings without organized cervical screening programs (27).…”

Section: Discussionsupporting

confidence: 80%

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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

et al. 2012

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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...

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Section: Discussionsupporting

confidence: 82%

Section: Discussionsupporting

confidence: 80%

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

et al. 2012

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“…Lavages, with new self-sampling devices, have also been tested in clinical trial settings. 15,16 Many soluble factors (e.g. inflammatory cytokines) have short half-lives and will break down quickly.…”

Section: The Collection Of Soluble Factorsmentioning

confidence: 99%

Methodological Issues in Sampling the Local Immune System of the Female Genital Tract in the Context of HIV Prevention Trials

Jespers

Francis

Wijgert

et al. 2010

American J Rep Immunol

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Citation  Jespers V, Francis SC, van de Wijgert J, Crucitti T. Methodological issues in sampling the local immune system of the female genital tract in the context of HIV prevention trials. Am J Reprod Immunol 2011; 65: 368–376 The spread of HIV continues unabated in the most vulnerable populations of the world. HIV prevention methods, such as a vaginal microbicide, a mucosal vaccine, pre‐exposure prophylaxis or a vaccine, are urgently needed in the fight against new infections. We must make a commitment to supporting innovative research and product design, so that one or more of these products provide a halt to the spread of HIV. Above all, these products should be proven to be safe and not negatively disturb the local immune system in a way that facilitates or enhances heterosexual transmission of HIV. HIV specific and non specific cellular and humoral local vaginal immunity must be assessed in clinical trials when testing prevention products for safety or efficacy. A proven, well‐documented and standardized sampling strategy will provide high quality data to be able to assess both safety and local immune responses. In this paper, we will discuss methods for vaginal immunology sampling in the context of clinical trials.

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“…Self-sampling by cervicovaginal lavage has been shown to be useful in previous studies to detect high-grade CIN (3,8,21) and was highly accepted in the Netherlands (11). The objective of our study was to evaluate if self-sampling by cervicovaginal lavage is a useful and valid approach to determine HPV prevalence in 20-to 30-year-old females and if the method is accepted in this target group in Germany.…”

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confidence: 99%

Cervicovaginal Self-Sampling Is a Reliable Method for Determination of Prevalence of Human Papillomavirus Genotypes in Women Aged 20 to 30 Years

et al. 2011

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Self-sampling by cervicovaginal lavage could be an attractive method to detect high-risk human papillomavirus (hr-HPV) infections to identify women with a risk of cervical precancer. The objective of our study was to use self-sampling for the first time in a cross-sectional approach to determine HPV prevalence and genotype distribution. We evaluated participants' acceptance and laboratory results from self-obtained samples versus endocervical brush samples obtained by gynecologists. To determine the sensitivity of both sampling methods in presumed high-and low-prevalence settings, two groups of women 20 to 30 years of age with (n ‫؍‬ 55) and without (n ‫؍‬ 101) a recent suspicious cytological smear were compared. Overall, 76% (95% confidence interval [95% CI], 65 to 88) of women with and 40% (95% CI, 30 to 49) of women without a recent suspicious cytological smear tested HPV positive. The prevalences of high-risk HPV strains were 71% (95% CI, 59 to 83) and 32% (95% CI, 22 to 41), respectively, for these two groups. The agreement for hr-HPV between the two sampling methods for women with and without suspicious cytology was 84% ( ‫؍‬ 0.65; 95% CI, 0.44 to 0.86) and 91% ( ‫؍‬ 0.78; 95% CI, 0.64 to 0.92), respectively. Participants rated the user-friendliness of the self-sampling method on a visual analog scale from 0 (easy) to 100 (difficult) with a median of 12. In conclusion, self-sampling by cervicovaginal lavage is a reliable method to determine hr-HPV prevalence and is well accepted by young adult females.Cervical cancer is the second most common cancer in women worldwide, with globally approximately 500,000 new cases and 250,000 deaths each year (http://www.who.int /reproductivehealth/topics/cancers/en/). The strong correlation between cervical cancer and a preceding persistent infection of the cervix with human papillomavirus (HPV) is beyond dispute (2, 18). More than 130 genotypes of HPV have been classified (6), of which about 40 genotypes can infect the anogenital tract (14). Of these 40 genotypes, nearly 20 are thought to be carcinogenic and are classified as high-risk HPV (hr-HPV). Genotypes 16 and 18 alone are associated with approximately 50% of high-grade cervical intraepithelial neoplasia (CIN) and 70% of cervical cancers (4, 20). Anogenital HPV infections are predominantly sexually transmitted, and nearly all sexually active women will be infected at some point during their lifetime (1). Most HPV infections are transient, but persistent infections can progress over years to high-grade CIN or cervical cancer.Vaccines against HPV genotypes 16 and 18 have been available since 2006. Results from clinical trials indicate high effectiveness against high-grade CIN when HPV-naïve girls and women are vaccinated (7,16,17). Numerous industrial countries have implemented vaccination programs to protect girls against infections with HPV types 16 and 18. Target groups for the vaccination are mainly adolescent women preceding their sexual debut. To monitor the impact of the vaccine and the implemented vaccination...

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Women in the Netherlands Prefer Self-Sampling With a Novel Lavaging Device to Clinician Collection of Specimens for Cervical Cancer Screening

Cited by 20 publications

References 8 publications

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

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

Methodological Issues in Sampling the Local Immune System of the Female Genital Tract in the Context of HIV Prevention Trials

Cervicovaginal Self-Sampling Is a Reliable Method for Determination of Prevalence of Human Papillomavirus Genotypes in Women Aged 20 to 30 Years

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