Many methods are available today for HPV testing: they differ for technology, targets, and information on the genotypes detected. A key issue is represented by the differences in analytical and clinical sensitivity, especially in case of genotyping. Aim of this work was the evaluation of BD Onclarity HPV assay in a group of patients referred to the European Institute of Oncology of Milan for a cervical lesion.
One hundred sixty-seven women scheduled to be conservatively treated for a CIN2+ lesion were enrolled. For all the patients a cervical sample was taken before treatment, and the results of Qiagen Hybrid Capture 2 and Roche Linear Array HPV Test, cytology and histology were available. BD Onclarity was performed on a left-over aliquot.
Concordance of HC2 and Onclarity was 92% (150/163), with 13 samples giving discordant results (4 hc2 negative and Onclarity positive – 2 CIN3 and 1 Carcinoma histology- 9 hc2 positive and Onclarity negative – 3 CIN1 and 6 CIN3 histology (2 of which were also Linear Array negative)). Looking at genotyping a complete concordance was found in 75.5% (126/167 of the cases), reaching the 86% when adding the samples partially concordant in case of multiple infections.
This study performed in a group of women with a high prevalence of disease showed a good concordance between HC2 and Onclarity in the cervical samples taken before treatment. Regarding genotyping the comparison with Linear Array confirmed a good concordance between the two methods.