Polman NJ, et al. - In this randomized, non-inferiority trial, researchers assessed the clinical accuracy of primary human papillomavirus (HPV) testing on self-collected samples within an organized screening setting. Detection of cervical intraepithelial neoplasia (CIN) of grade 2 or worse (CIN2+) and grade 3 or worse (CIN3+) were primary endpoints. Investigators observed that HPV tests performed with a clinically validated PCR-based test had similar accuracy in the detection of CIN2+ or CIN3+ lesions in self-collected and clinically-collected samples. According to findings, HPV self-sampling could be used in routine screening as a primary screening method.

Methods

• Women between the ages of 29 and 61 were invited to take part in the study.
• Women who gave informed consent were randomly assigned (1:1, with a block size of ten stratified by age) to either a self-sampling group, in which women were requested to collect their own cervicovaginal sample using an Evalyn Brush (Rovers Medical Devices BV, Oss, Netherlands) or a clinician-based sampling group, in which samples were collected by a general medical practitioner with a Cervex-Brush (Rovers Medical Devices BV).
• Using the clinically validated GP5+/6+ PCR enzyme immunoassay (Labo Biomedical Products BV, Rijswijk, Netherlands), all samples were tested for HPV.
• In accordance with current Dutch screening guidelines, HPV-positive women in both groups were retested with the other collection method and triaged by cytology and repeat cytology.
• Detection of CIN of grade 2 or worse (CIN2+) and grade 3 or worse (CIN3+) were primary endpoints.
• Non-inferiority of HPV testing on self-collected vs clinician-collected samples was assessed against a margin of 90% for the relative sensitivity and 98% for the relative specificity.

Results

• Of the 187,473 women invited, 8,212 were allocated randomly to the self-sampling group and 8,198 to the clinician-based sampling group.
• After excluding women who met or did not return their sample, 7,643 women were included in the self-sampling group and 6,282 in the clinician-based sampling group.
• Findings revealed that 569 (7.4%) self-collected samples and 451 (7.2%) clinician-collected samples tested positive for HPV (relative risk 1.04 [95% CI 0.92–1.17]).
• It was noted that median follow-up duration for HPV-positive women was 20 months (IQR 17–22).
• They observed that the CIN2+ sensitivity and specificity of HPV testing did not vary between self-sampling and clinician-based sampling (relative sensitivity 0.96 [0.90–1.03]; relative specificity 1.00 [0.99–1.01]).
• Relative sensitivity was 0.99 (0.91–1.08) and relative specificity was 1.00 (0.99–1.01) for the CIN3+ endpoint.