TRIAGE OF PRIMARY HPV TESTING COMBINED WITH SELF-SAMPLING USING HPV 16/18 GENOTYPING AND/OR CYTOLOGY. A SUB-ANALYSIS OF THE GRECOSELF STUDY (ID 192)
Abstract
Introduction
Triage of HPV positive women to colposcopy is necessary in the framework of HPV-based primary cervical cancer screening combined with self-sampling. Within the GRECOSELF study, a nationwide cross-sectional study on HPV-DNA testing with self-sampling, we evaluated HPV 16/18 genotyping and cytology for the triage of women tested HPV positive on self-collected cervicovaginal samples.
Methods
Women between 25-60 years old, who resided in rural Greece were provided with a dry swab for cervicovaginal sampling. Each sample was tested for high-risk (hr) HPV with the cobas® HPV test, which detects HPVs 16 and 18 separately, and HPVs 31,33,35,39,45,51,52,56,58,59,66 and 68 as a pooled result. HrHPV positive women were referred to colposcopy/biopsy. A sample collected prior to colposcopy was used for Liquid-based cytology (LBC).
Results
Between May 2016 and November 2018, 13,111 women were recruited. Of these 1070 (8.3%) were hrHPV positive. Amongst those women there were 297 (2.3%) tested positive for HPV 16 and/or 18. Of the 1070 hrHPV positive women, 773 (72.2%) accepted to undergo colposcopy. A cervical sample was collected, prior to colposcopy, in 317 women out of the 773 who underwent colposcopy. Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) was detected in 75 cases (0.6%). The optimal trade-off between sensitivity and positive predictive value (PPV) was presented by the combination of partial genotyping (HPVs 16/18) and cytology (for the non-16/18 hrHPV positive cases), i.e. sensitivity 96.55% [confidence interval (CI): 91.86-100.0%)], and PPV 23.33% (CI: 17.98-28.68).
Conclusions
For women residing in rural Greece, who were tested positive for hrHPV DNA with the cobas HPV test on self-collected cervicovaginal samples, the optimal triage strategy was HPV 16/18 genotyping combined with cytology for the non-16/18 hrHPV positive cases.
