Evaluation of BD Onclarity™ HPV Assay on Self-Collected Vaginal and First-Void Urine Samples as Compared to Clinician-Collected Cervical Samples: A Pilot Study

The accuracy of available HPV molecular assays on self-samples needs to be evaluated as compared to clinician-collected samples. This pilot study aimed to investigate the BD Onclarity (TM) HPV assay on vaginal and first-void urine samples. Sixty-four women referred to colposcopy for cervical dysplasia performed a vaginal self-collection and provided a first-void urine sample, after informed consent. A cervical specimen was collected during the clinician examination. All samples were tested using BD Onclarity (TM) HPV assay on the BD Viper (TM) LT System. Overall positive agreement (OPA) between cervical and self-sample results was evaluated using Cohen's kappa value (kappa). Using a clinical cut-off of 38.3 Ct for HPV 16 and 34.2 Ct for other HR genotypes, compared to cervical sample, the self-collected vaginal sample OPA was 85.9%, and kappa = 0.699. Without a clinical cut-off, the OPA was 95.3%, and the kappa = 0.890. Data obtained comparing cervical and urine samples showed an OPA of 87.5% with a kappa = 0.79 using a clinical cut-off, and an OPA of 90.6% with a kappa = 0.776 without a clinical cut-off. Data showed a substantial agreement between both self-collected and clinician-collected samples. A specific clinical cut-off analysis should be considered based on type of sample analysed.

Automated summary

This study aimed to evaluate the accuracy of self-samples using the BD Onclarity (TM) HPV assay on vaginal and first-void urine samples compared to clinician-collected samples. The results showed substantial agreement between self-collected and clinician-collected samples for both vaginal and urine samples.