Large‐Scale Study Comparing Analytical and Diagnostic Quality of Three HPV Self‐Sampling Devices for At‐Home Cervical Cancer Screening

ABSTRACT

Elimination of cervical cancer requires broad access to and participation in cervical screening. Self‐sampling has emerged as a robust technology that simplifies access; however, few self‐sampling devices are independently validated regarding sample quality. This study compares the quality of three self‐sampling devices: Evalyn (Rovers), currently used in Denmark, the FLOQSwab (Copan) and the modified FLOQSwab: SensiGrip. Women residing in the Capital Region of Denmark, accepting screening by self‐sampling, were offered a kit containing the following combinations of devices: (1) Evalyn, FLOQSwab, (2) Evalyn, SensiGrip or (3) FLOQSwab, SensiGrip. Returned kits were analyzed using the validated BD Onclarity HPV assay on the COR instrument (BD). A total of 1677 women participated. Sample quality was similar across devices, also when stratifying into age groups. Two hundred thirty‐two women (13.9%) tested positive for one or more oncogenic HPV types. Pairwise concordance analysis for each group showed an overall agreement between 93.5% and 95%. Analytical and diagnostic performance of samples collected by the three self‐sampling devices resulted in similar quality and HPV detection. Hence the sample quality is not a determinant in the choice of sampling device and focus on other factors such as cost, women's preference or size and weight can take precedence.