*Article* **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**

**Marianna Martinelli <sup>1</sup> , Chiara Giubbi <sup>1</sup> , Illari Sechi <sup>2</sup> , Fabio Bottari 3,4 , Anna Daniela Iacobone 4,5 , Rosario Musumeci <sup>1</sup> , Federica Perdoni <sup>1</sup> , Narcisa Muresu <sup>6</sup> , Andrea Piana <sup>2</sup> , Robert Fruscio <sup>7</sup> , Fabio Landoni <sup>7</sup> and Clementina Elvezia Cocuzza 1,\***


**Citation:** Martinelli, M.; Giubbi, C.; Sechi, I.; Bottari, F.; Iacobone, A.D.; Musumeci, R.; Perdoni, F.; Muresu, N.; Piana, A.; Fruscio, R.; et al. 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. *Diagnostics* **2022**, *12*, 3075. https://doi.org/10.3390/ diagnostics12123075

Academic Editor: Laurent Bélec

Received: 9 November 2022 Accepted: 30 November 2022 Published: 7 December 2022

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**Abstract:** 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™ 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™ HPV assay on the BD Viper™ LT System. Overall positive agreement (OPA) between cervical and self-sample results was evaluated using Cohen's kappa value (κ). 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 κ = 0.699. Without a clinical cut-off, the OPA was 95.3%, and the κ = 0.890. Data obtained comparing cervical and urine samples showed an OPA of 87.5% with a κ = 0.79 using a clinical cut-off, and an OPA of 90.6% with a κ = 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.

**Keywords:** human papillomavirus; self-collection; vaginal self-sample; first-void urine; cervical cancer screening; diagnostic accuracy
