Introduction

An increasing number of countries and international cancer organisations recommend screening using clinically validated tests that identify nucleic acid sequences of carcinogenic HPV types.
HPV testing and clinical validation of HPV assays Ample evidence indicates that cervical cancer screening using assays targeting carcinogenic human papillomavirus (HPV) types, followed by management of HPV-positive women offers stronger protection against future cancer of the cervix uteri than cytology-based screening1,2. Therefore, an increasing number of countries and international cancer organisations have switched or are in the phase of switching to virological screening and recommend screening using clinically validated tests that identify nucleic acid sequences of carcinogenic HPV types3 . Whereas hundreds of different HPV assays are commercially available, only a small minority of them have demonstrated fulfilment of the international validation criteria defined by Meijer et al in 20094-6. The clinical validation of a new index HPV assay for use in cervical cancer screening requires that the new assay demonstrates non-inferior sensitivity and noninferior specificity to detect cervical intraepithelial neoplasia of grade 2 (CIN2) or worse compared to a first or second-generation comparator test. The benchmarks for relative sensitivity and specificity (index versus comparator assay) are ≥0.90 and ≥0.98, respectively6 . Practically this means that the left 90% confidence interval bound (CIB) around the relative sensitivity or relative specificity is not lower than these benchmarks