Only new HPV tests that show similar sensitivity and specificity for the detection of CIN3+ as HC2 or GP5+/GP6+ should be used in cervical cancer screening programs. We evaluated the performance of Onclarity for the detection of HR-HPV compared with HC2 in a German HPV screening program and the utility of Onclarity genotyping for the triage of HR-HPV positive women compared with p16/Ki-67.
Women attending for their 1st, 2nd or 3rd HPV&Pap screening round in WOLPHSCREEN were included. Participants were 30-70 years old, hysterectomy was an exclusion criterion. All underwent Pap smear and HC2 co-testing with 5 years intervals for women with normal findings. In 2015/16 ThinPrep samples of 4,699 participants were tested with Onclarity in a non-interventional followed by an interventional trial with 2,781 women in 2016/17. In this second phase women were called for colposcopy when Onclarity tested positive for HPV 16, 18, 31, 33, 45 or 58.
The overall HR-HPV prevalence was 7.0% with Onclarity and 8.47% with HC2. Only 40/4,301 HC2 negative samples were tested positive with Onclarity (0.93%). Sensitivity of Onclarity for CIN2+ was 93% (40/43), specificity 94.2%, NPV 99.9% and PPV 10.7%. Genotyping for HPV 16, 18, 31, 33, 45 or 58 and p16/ki-67 triage showed an identical sensitivity of 79.1% for CIN2+.
The overall performance of Onclarity HR-HPV testing was non-inferior to HC2 in WOLPHSCREEN. Onclarity showed a better specificity than HC2 while sensitivity for CIN2+ was slightly lower. Primary screening with Onclarity and the use of genotyping to triage HR-HPV positive cases seem feasible.