Large-Scale Study Comparing Analytical and Diagnostic Quality of Three HPV Self-Sampling Devices for At-Home Cervical...

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.