*2.1. Study Design and Sample Collection*

For this pilot study of diagnostic accuracy, a group of 64 women (mean age: 38.4 years) with a recent diagnosis of cervical dysplasia attending the Colposcopy Clinic of San Gerardo Hospital (Monza, Italy) were enrolled. The study protocol was approved by the Ethics Committee of the University of Milano-Bicocca, Monza, Italy (Protocol n. 0037320/2017 and 0086409/2018). All subjects provided written and informed consent to participate in the study. Patients were excluded in case of immunodeficiency, HIV infection, presumed or confirmed pregnancy, diagnosis of any malignancies, and/or chemotherapy in the previous 6 months.

All women were adequately informed about the study by Colposcopy Clinic staff and were asked to autonomously collect a vaginal self-sample using a FLOQSwab® (5E046S, Copan, Brescia, Italy) and a first-void urine (FVU) sample using a Colli-pee® 20 mL (Novosanis, Wijnegem, Belgium) before colposcopy examination. The information brochure of the study and the instructions on how to use the devices were given to all participants.

During the colposcopy examination, the gynaecologist collected one cervical sample using an L-shaped FLOQSwab® (Copan). All physician-collected cervical and self-collected vaginal and urine samples were sent to the Clinical Microbiology Laboratory of the Department of Medicine and Surgery, University of Milano-Bicocca, Italy, for preanalytical processing within 24 h of collection.
