Performance of the Xpert HPV assay in women attending for cervical screening

•This is the first study to report on the performance of the Xpert HPV Assay in a screening population.•Xpert HPV Assay׳s performance in detecting HPV is comparable to two clinically validated HPV tests.•Xpert HPV Assay showed a relative sensitivity of 98.73% for CIN 2 or higher and 100% for CIN3 or higher.

ObjectivesThis study evaluated the Xpert HPV Assay in women attending screening in general practice by comparing Xpert with two established HPV tests, cytology and histology.MethodsA prospective study in women aged 20–60 years attending screening in Bristol, Edinburgh and London using residual Preservcyt cytology samples. Sample order was randomised between Roche cobas4800 and Cepheid Xpert assays with Qiagen hc2 third.Results3408 cases were included in the primary analysis. Positivity for Xpert was 19.6%, cobas 19.2% and hc2 19.9% with high concordance (kappa=86.8% vs cobas, 81.55 vs hc2). Xpert, cobas and hc2 showed similar sensitivity (98.7%, 97.5%, 98.7%) for CIN2+. All pairwise comparisons had high concordance (Kappa ≥0.78 with any abnormal cytology. Xpert and hc2 were positive for all cases of ≥moderate dyskaryosis (N=63)), cobas was negative in two. Histology was available for 172 participants. 79 reported CIN2+, 47 CIN3+. All CIN3+ was positive on Xpert and hc2 and one case negative for cobas. One case of CIN2 was negative for all assays.ConclusionsThe performance of Xpert HPV Assay in a general screening population is comparable to established HPV tests. It offers simplicity of testing, flexibility with non-batching of individual samples and rapid turnaround time.