Human papillomavirus self‐sampling with mRNA testing benefits routine screening

High risk human papillomavirus (hrHPV) based screening provides the possibility of vaginal self‐sampling as a tool to increase screening attendance. In order to evaluate the impact and feasibility of opt‐in self‐sampling in the Finnish setting, we invited a randomized population of 5350 women not attending screening after age group invitation or after reminder, to attend HPV self‐sampling‐based screening in the autumn of 2018 in Helsinki. Out of those, 1282 (24.0%) expressed their interest and ordered the sampling package. Eventually 787 women (14.7% of the total invited population) took part in screening, 770 women by providing a vaginal sample within 2 months from invitation and 17 by providing a pap smear in the laboratory. Self‐taken samples were collected in Aptima Multitest vials and tested using the Aptima HPV mRNA assay. A high proportion, 158/770 (20.5%) of the samples were positive in the Aptima HPV assay. One hundred and forty‐one samples were further submitted to Aptima HPV Genotyping and extended genotyping by a Luminex based assay. Of those, 23 samples (16.3%) were HPV 16 positive and 7 (5.0%) were positive for HPV 18/45; extended genotyping revealed multiple high‐risk and low‐risk HPV genotypes. At follow‐up seven cases of high‐grade squamous intraepithelial lesion (HSIL) were diagnosed, which represents 4.4% of HPV positive women and 0.9% of screened women, whereas the rate was 0.5% in routine screening. Our findings suggest that self‐sampling with HPV mRNA testing is a feasible approach to improve screening efficacy in a high‐risk population among original nonattendees.