Self-sampling as the principal modality for population based cervical screening: Five-year follow-up of the PaVDaG study.

Abstract

Self‐sampling provides a powerful means to engage women in cervical screening. In the original Papillomavirus Dumfries and Galloway study (PaVDaG), we demonstrated cross‐sectional similarity of high‐risk human papillomavirus (Hr‐HPV) testing on self‐taken vaginal vs clinician‐taken samples for the detection of cervical intraepithelial neoplasia 2 or worse (CIN2+). Few data exist on the longitudinal performance of self‐sampling; we present longitudinal outcomes of PaVDaG. Routinely screened women provided a self‐taken and a clinician‐collected sample. Ninety‐one percent of 5136 women from the original cohort completed a further screening round. Sensitivity, specificity, positive predictive value and complement of the negative predictive value of the Hr‐HPV test on self‐samples for detection of CIN2+ and CIN3+ up‐to 5 years after testing were determined. Additionally, clinical accuracy of Hr‐HPV testing on vaginal and clinician‐collected samples was assessed. A total of 183 CIN2+ and 102 CIN3+ lesions were diagnosed during follow‐up. Risk of CIN2+ and CIN3+ following an Hr‐HPV negative self‐sample was 0.6% and 0.2%, respectively, for up to 5 years after testing. The relative sensitivity for CIN3+ and specificity for ≤CIN1 of Hr‐HPV testing on self‐taken specimens was slightly lower vs clinician‐collected samples: 0.95 (95% CI: 0.90‐0.99; P McN = .0625) and 0.98 (95% CI: 0.95‐1.00; P McN = <.0000), respectively. The low risk of CIN2+ in women with Hr‐HPV—self‐sample(s) suggests, that the 3 to 5‐year recall interval implemented in several cervical screening settings, based on clinician‐taken samples, may be safe for self‐samples. Future assessment will show if “universal” 5‐year screening is appropriate for programs based on self‐sampling.