Implementazione di nuove strategie diagnostiche per la prevenzione del cervico-carcinoma

Aim: The introduction of HPV-testing in cervical cancer screening has brought the growing of interest in the use of self-sampling to simplify and to increase the coverage of screening programs. The aim of the study was to evaluate HPV detection by a new diagnostics kit molecular using different types of self-collected samples compared to physician-collected samples.Methods: Self-collected vaginal samples using FLOQSwabs® (Copan), HerSwab® (Eve-medical), Evalynbrush®(Rovers Medical Devices), first void urine Colli-Pee™ (Novosanis) and physician administered cervical samples were collected from women referred to colposcopy at the Gynaecology Outpatients Clinic of San Gerardo Hospital, Monza, Italy. Samples were processed at the Microbiology Laboratory of the University Milano-Bicocca. Nucleic acid extraction was carried out by means NucliSENS®easyMAG (bioMérieux) and HPV was detected using Anyplex II HPV28 (Seegene) and HPV OncoPredict prototype that was used to assess samples cellularity and normalized hrHPV genotype-specific viral load. To evaluate the self-sampling level of satisfaction and acceptability, participants were asked to complete a self-administered questionnaire.Results: The data obtained showed an excellent high-risk HPV (hrHPV) detection concordance compared to cervical sample for self-collected vaginal and urine sample. From questionnaire analysis, the majority of women confirmed to have no problems in using all types of self-samples. Preliminary data using HPV OncoPredict prototype indicate an adequate cellularity for all sample types. The mean normalized viral load showed differences observed among different hrHPV genotypes as well as sample types.Conclusion: Preliminary results showed a high degree of concordance between clinical administered cervical sample and vaginal and urine self-collected sample. This could be a good alternative to improve screening coverage specially for hard to reach women that otherwise could avoid this crucial preventive examination due to high costs, embarrassment, discomfort and anxiety. HPV OncoPredict prototype preliminary evaluation showed promising results for the accurate determination of both sample cellularity and hrHPV viral load in both cervical and self-collected samples.