Background: Testing for hrHPV can improve existing screening programmes, but does not alter participation rates. Several studies have shown that self-sampling for hrHPV testing is highly acceptable to women, increases participation rate to screening and may therefore further reduce cancer incidence. However, it is important to assess clinical performance of self-collection devices in combination with clinically validated HPV test prior to use in cervical cancer screening.
Objectives: To evaluate the clinical performance of hrHPV testing on self-samples using a Rovers® Viba-brush to detect high-grade CIN (≥CIN2) lesions as an alternative to physician-taken smears.
Methods: The study group consisted of 135 women referred to the gynaecologist for colposcopy-directed biopsy; all took a self-collected brush sample at home prior to their visit to the outpatient clinic. Next, the gynaecologist took an endocervical smear, followed by colposcopy. All samples were immediately collected in PreservCyt preservation medium, and used for hrHPV testing (GP5+/6+-PCR-EIA). HrHPV results and clinical performance in terms of sensitivity and specificity for ≥CIN2 lesions of hrHPV testing were compared between the different sampling methods.
Results: hrHPV test results showed good concordance between sample types; kappa 0.70 (95% CI: 0.60-0.78) for agreement of self-collected brush-based samples with physician-taken cervical samples. Sensitivity and specificity of hrHPV testing for underlying ≥CIN2 lesions did not differ significantly (self-sample: 93% and 51%; physician-taken cervical sample: 90% and 51%; McNemar, P =1,000).
Conclusions In combination with hrHPV testing, self-samples taken by this device are highly representative to determine the cervical ≥CIN2 status. Therefore, this device might be used to re-attract non-attendees in population-based screening, or even for primary hrHPV-based cervical screening.
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