Comparison of Anyplex II HPV HR- and Hybrid Capture2 testing in a screening population (WOLPHSCREEN)

Introduction: WOLPHSCREEN (Wolfsburg primary HPV screening for better cervical cancer prevention) comprises 24,000 women aged 30+ years who attended for routine screening between 2006 and 2016. In July 2015 we tested samples with Anyplex-II-HPV-HR (Seegene Inc) for HPV genotypes to compare Anyplex with HC2 results as gold standard.

Methods: Selected samples were originally tested in 2007 with Hybrid Capture2 (HC2). A first set of stored and fresh samples tested earlier showed that the 2007 samples were still of good quality. 271 samples were tested for HPV with Anyplex in 2015. Diagnoses are based on the maximum findings within long-term follow-up and are therefore more reliable than in cross-sectional trials.

Results: Overall 109 out of 116 HC2 positive CIN1+ tested positive for HPV high risk types with Anyplex (94%). All CIN3+ tested positive for HPV-HR with Anyplex (35/35 = 100%). Sensitivity and NPV for CIN3+ were excellent and reached 100% in this cohort. 11 out of 150 HC2-negative samples tested positive for HR-HPV-types. Type distribution of the 14 individual HPV types resembled very much the distribution pattern found with LiPA genotyping in WOLPHSCREEN. HPV16 is the most frequent type in CIN3+ lesions but not as frequent (< 50%) as observed among young women aged 20 – 25 years (78 – 88%).

Conclusions: Anyplex showed an excellent sensitivity for CIN3+ and a plausible pattern of genotype distribution. The data is not sufficient for a reliable conclusion of the observed low specificity in HC2 negative samples.