Testing and Genotyping of High-Risk Human Papillomavirus by the cobas HPV Test and the Hybrid Capture 2 High-Risk HPV DNA Test Using Cervical and Vaginal Samples

The accurate detection and typing of high-risk human papillomavirus (HPV) are critical for cervical cancer screening. The Hybrid Capture 2 (hc2) and cobas HPV tests showed high agreement for cervical samples (94.4%, kappa=0.72,n= 693) and moderate agreement for vaginal samples (kappa = 0.62, n = 108). The HPV16 and HPV18 results were highly consistent between the cobas and Linear Array tests (kappa >= 0.96, n = 197). Three hc2-negative vaginal samples were repeatedly invalid by the cobas test due to beta -globin control failures, highlighting amplification control benefits. No cross-contamination was detected in a challenge experiment.