Performance and pre-analytical stability of self-collected samples versus clinician cervical samples for the detection of HPV16, HPV18 and a pool of 12 other HPV types on the Roche Cobas 8800 System.

This study aimed to validate the agreement between human papillomavirus (HPV) tests self-collected samples versus clinician cervical specimens, and the pre-analytical stability of self-sampling. One hundred and fifty-seven women aged between 25 and 65 years who presented to the gynaecological department of the "CLEMENTVILLE" clinic in Montpellier voluntarily participated in HPV screening by self-sampling. Polymerase chain reaction was used to detect the presence of HPV16, HPV18 and a pool of 12 other HPV types on the Roche Cobas 8800 System. Median age was 40 years (range 20-73 and IQR 31-49 years). The overall HPV prevalence on the population studied was 27%. The agreement between clinician cervical samples and self-collected vaginal presented good agreement (Kappa =0.90) and high sensitivity (0.91) and specificity (0.98). For swabs stored for 7 days at room temperature, the HPV results presented substantial agreement (Kappa =0.89) and high sensitivity (0.97) and specificity (0.93). Our data showed that the HPV assay performed in the self-collected vaginal samples have high consistency of results with the clinician cervical samples. The use of self-collected cervical sample could be a simple and inexpensive approach in cervical cancer screening programs due to their high pre-analytical stability.