**5. Conclusions**

Overall, data analysis without adjustment resulted in substantial agreement between the self-collected and clinic-collected samples, with PPA values of 83.7% and 90.7% for vaginal and urine samples, respectively. With correction for excess dilution in the sample preparation, there was almost perfect agreement, with PPA values of 100% and 97.7% for vaginal and urine samples, respectively. In conclusion, data from this pilot study are promising for the employment of the BD Onclarity™ HPV assay on vaginal samples and first-void urine samples, with an accuracy almost equivalent to clinician-collected cervical samples.

**Author Contributions:** Conceptualization, C.E.C.; methodology, M.M., I.S., F.P., N.M. and F.B.; formal analysis, M.M., F.B. and C.G.; data curation, M.M., C.G., R.M., N.M. and C.E.C.; writing—original draft preparation, M.M., C.G., A.D.I., F.B. and C.E.C.; writing—review and editing, M.M., C.G., A.D.I., F.B., R.M., R.F., F.L., N.M., A.P., I.S. and C.E.C.; supervision, C.E.C. All authors have read and agreed to the published version of the manuscript.

**Funding:** This research received no external funding. BD Onclarity™ HPV assays were donated by BD; FLOQSwab® L-shape and vaginal self-samples were donated by Copan; Colli-pee® devices were donated by Novosanis.

**Institutional Review Board Statement:** The study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of the University of Milano-Bicocca (Protocol n. 0037320/2017 and 0086409/2018).

**Informed Consent Statement:** Informed consent was obtained from all subjects involved in the study.

**Conflicts of Interest:** The authors declare no conflict of interest.
