The BD Onclarity HPV assay on SurePath collected samples meets the International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

This study describes a validation of the BD Onclarity HPV (Onclarity) assay using the international guidelines for HPV test requirements for cervical cancer screening of women 30 years and above using Danish SurePath screening samples. The clinical specificity (0.90, 95% CI: 0.88-0.91) and sensitivity (0.97, 95% CI: 0.87-1.0) of the Onclarity assay were shown to be non-inferior to the reference assay (specificity 0.90, 95% CI: 0.88-0.92, sensitivity 0.98, 95% CI: 0.91-1.0). The intra-laboratory reproducibility of Onclarity was 97% with a lower confidence bound of 96% (kappa value: 0.93). The inter laboratory agreement was 97% with lower confidence bound of 95% (kappa value: 0.92). The BD Onclarity HPV assay fulfills all the international guidelines for a new HPV test to be used in primarily screening. This is the first clinical validation of a new HPV assay using SurePath screening samples and thus the Onclarity HPV assay is the first HPV assay to hold an international validation for both SurePath and ThinPrep.