Evaluation of the compatibility of the Digene media when performing the Roche linear array human papillomavirus genotyping test

Abstract

This study was performed to evaluate the compatibility of the Digene media when performing the Roche linear array human papillomavirus (HPV) genotyping test. A total of 258 samples from 166 women were tested using the Hybrid Capture 2 (HC2) assay, the Cytyc media-based linear array test, and the Digene media-based linear array test. The results between the HC2 assay and the Digene media-based linear array test were highly concordant (kappa = 0.78). The Cytyc media-based linear array test and Digene media-based linear array test exhibited substantial agreement in 207/249 cervical samples (kappa = 0.62). The two genotyping test also showed substantial agreement for the detection of HPV genotypes 16, 18, 52, 58 and for 18 HPV genotypes including both high-risk, and possible high-risk genotypes (kappa = 0.74, 0.69, respectively). We found Digene media to be interchangeable with Cytyc media when performing the Roche linear array genotyping test. This may be clinically meaningful in that we could perform the Roche linear array genotyping test with the same Digene media among women, positive for HC2 assay without the need for a return visit.