BackgroundWe are presenting the results of the Slovenian human papillomaviruses (HPV) self-sampling pilot study in colposcopy population of National Cervical Cancer Screening Programme ZORA for the first time. One-year and four-year follow-up results are presented for two different self-sampling devices.Participants and methodsA total of 209 women were enrolled in the study at colposcopy clinic. Prior to the gynaecological examination, all women performed self-collected vaginal swab at the clinic; 111 using Qvintip and 98 using HerSwab self-sampling device. After self-sampling, two cervical smears were taken by a clinician; first for conventional cytology and second for HPV test. After that, all women underwent colposcopy and a cervical biopsy if needed. We compared sensitivity, specificity, and predictive values of cytology (at the cut-off atypical squamous cells of undetermined significance or more [ASC-US+]) and HPV test (on self- and clinician-taken samples) for the detection of cervical intraepithelial neoplasia grade 2 or more (CIN2+) after one and four years of follow-up. Hybrid Capture 2 (HC2) assay was used for all HPV testing.ResultsThe mean age of 209 women was 37.6 years and HPV positivity rate 67.0% (140/209), 36.9 years and 70.3% (78/111) in the Qvintip group and 38.4 years and 63.3% (62/98) in the HerSwab group, respectively. Overall, percent agreement between self and clinician-taken samples was 81.8% (kappa 0.534) in the Qvintip and 77.1% (kappa 0.456) in the HerSwab group. In the Qvintip group, the longitudinal sensitivity, specificity, positive and negative predictive values were 71.8%, 75.0%, 83.6%, 60.0% for cytology; 83.1%, 51.3%, 75.6% and 62.5% for HPV test of self-taken samples and 94.4%, 57.5%, 79.8% and 85.2% for HPV test on clinician-taken samples. In the HerSwab group, the corresponding results were 71.7%, 46.7%, 61.3%, 58.3% for cytology; 75.0%, 47.7%, 62.9% and 61.8% for HPV test on self-taken samples and 94.3%, 44.4%, 66.7% and 87.0% for clinician-taken samples, respectively.ConclusionsThe results confirm that HPV self-sampling is not as accurate as clinician sampling when HC2 is used. All HPV tests showed a higher sensitivity in detecting CIN2+ compared to cytology. Due to non-inferior longitudinal sensitivity of HPV self-sampling compared to cytology, HPV self-sampling might be an option for non-attenders to the National Cancer Screening Programme.

Cervical cancer screening has successfully reduced the incidence and mortality of cervical cancer in many countries. In Slovenia, the incidence of cervical cancer decreased in 2003–2015 by almost 50%. Participation in screening has reached about 72% over the last 3 years. The main cause of cervical cancer is infection with human papillomaviruses (HPVs). For this reason, in 2010, HPV testing was included in the national screening programme ZORA for triage of low-grade lesions and as a test of cure in 2010. Even though screening is free ofcharge and accessible in Slovenia, about 30% of women still do not respond to invitations and are not screened regularly, especially women aged 50–64 years. HPV self-sampling could improve the detection of precancerous changes among non-attenders of the cervical cancer screening program. By using a validated PCR HPV DNA test, cervical and vaginal HPV sampling have similar accuracy for the detection of CIN 2+, resulting in the same or higher accuracy than the Pap test. Women describe HPV self-sampling as user-friendly, intimate, less embarrassing, and less painful than the Pap smear. About one-quarter to one-third of non-attenders of regular screening responded to the invitation to perform self-sampling. In a Slovenian randomised trial, the overall response rate was more than one-third and was not much higher in an opt-outcompared to opt-in approach. HPV self-sampling could lead to an improvement in the detection of precancerous cervical lesions. European guidelines for quality assurance on cervical cancer screening recommend HPV self-sampling in women who do not attend regular cervical screening programmes.