Analytical comparison of the cobas HPV Test with Hybrid Capture 2 for the detection of high-risk HPV genotypes.

Human papillomavirus (HPV) is a causal agent of cervical cancer, and persistent HPV16 or HPV18 infection carries a particularly high risk. The cobas HPV Test (cobas) provides individual HPV16/HPV18 genotyping with a simultaneous result for 12 other high-risk HPV (hrHPV) genotypes. Its analytical performance for hrHPV genotype detection was retrospectively evaluated against the digene Hybrid Capture 2 HPV DNA test (HC2), in three European centers, in 1360 cervical samples. Both HPV tests performed similarly, with no significant difference in the number of positive and negative samples identified by each test and good agreement between the tests was observed. Discordant samples were analyzed with the Linear Array HPV genotyping test. More low-risk HPV (lrHPV) genotypes were detected in HC2-positive/cobas-negative samples compared with HC2-negative/cobas-positive samples. Conversely, more hrHPV genotypes were detected in HC2-negative/cobas-positive samples compared with HC2-positive/cobas-negative samples. Eight HC2-negative/cobas-positive samples were positive for HPV16 compared with five HC2-positive/cobas-negative samples; HPV18 was detected in one HC2-negative/cobas-positive sample and one HC2-positive/cobas-negative sample. The cobas HPV Test demonstrates comparable analytical performance to the HC2 test, but with a lower rate of cross-reactivity with lrHPV genotypes, and has the advantage of simultaneously providing HPV16/HPV18 identification.