Validated high-risk human papillomavirus (hrHPV) assays are more effective than cytology in cervical cancer screening however the current assays take several hours to complete. The Cepheid GeneXpert HPV assay (Xpert HPV) is a novel, non-batch real-time PCR assay capable of detecting 14 hrHPV types in 1 hour.
One of the three validation criteria for the use of a novel hrHPV DNA assay in cervical cancer screening pertains to reproducibility. This study aims to determine whether the lower bound of 95% confidence interval of the intra- and inter-laboratory agreement of the Xpert HPV exceeds 87% with kappa ≥0.5.
A panel of 510 cervical cell samples from women attending screening, composed in the AML laboratory (Antwerp, Belgium) were retested twice with Xpert HPV within AML and subsequently retested in the virology laboratory of University Hospital Ghent.
Results: Xpert HPV showed high intra-laboratory reproducibility with an overall agreement of hrHPV positivity of 96.9% (95% CI, 95.0 to 98.2%) with kappa = 0.925 (95% CI 0.888-0 .961). Inter-laboratory testing showed an agreement of 97.8% (95% CI, 96.2 to 98.9%] with kappa = 0.948 (95% CI 0.917-0.978).
Retesting for presence of hrHPV DNA in cervical cell samples with the Xpert HPV shows a high level of concordance. The assay fulfills the international reproducibility criterion for use in cervical cancer screening.