Performance of HPV Self-Sample Collected by a Novel Kit in Comparison with Clinician Collected Sample for Cervical Cancer Screening.

Background and objectives: We are reporting the performance of HPV self-sample collected by a novel kit in comparison with clinician collected cervical sample for HPV testing for cervical cancer screening.

Methods: Consenting, eligible women aged 25 to 60, with a positive cervical cancer screening test report in the past one year but without any prior treatment for cervical abnormalities were enrolled in the study. Each woman provided 2 samples for the HPV test (vaginal self-sample collected with the CERVICHECKTM, an indigenous kit from India and cervical sample collected by the clinician). These samples were analysed using cobas HPV test on 4800 platform and for liquid-based cytology.

Results: We enrolled 156 eligible, consenting participants at 2 study sites. The agreement for the sample collected by CERVICHECKTM and clinician collected sample for any high-risk HPV was 95.1% (k= 0.90, SE 0.036, 95% CI 0.83-0.97). The agreement for HPV 16 or 18 only was 95.1%, (k=0.88, SE 0.045, 95% CI 0.79-0.97). The overall acceptability of the kit was good, participants expressed that self-sampling was easy and > 90% women were willing to recommend it to their friends.

Interpretation and conclusions: There was almost perfect or perfect agreement between the HPV self-sample collected by CERVICHECKTM and clinician collected cervical sample. Self-sampling was highly acceptable to the participating women.