Comparison of urine and cervical samples for detecting human papillomavirus (HPV) with the Cobas 4800 HPV test

Abstract Background Human papillomavirus (HPV) is the main cause of cervical cancer. The development of non-invasive self-sample collection methods would have the potential advantage of increasing the acceptance of the screening procedures. Objectives To compare human papillomavirus (HPV) DNA detection and genotyping with the Cobas 4800 HPV test (Roche Diagnostic, Spain) on paired cervical and first voided urine. Study design Paired urine and cervical samples were collected from 125 women referred for evaluation of abnormal Pap smear results. Results The overall percent agreement between HPV detection in urine and cervical samples was 88%. A substantial concordance rate of HPV DNA detection in both samples was observed ( κ  = 0.76; 95% IC: 64–87). In this high prevalence population the sensitivity, specificity, NPV and PPV for detection of HPV DNA from urine versus cervical samples were 90.5% (95% IC: 80–95%), 85%, (95% IC: 74–92%), 89.8% (95% IC: 79.5–95.3) and 86.4% (95% IC: 76.1–92.7) respectively. Compared to histologically confirmed CIN 2/3 disease, the clinical sensitivity and specificity for the detection of high-risk HPV in urine samples were 95% (95% IC: 76–97%) and 52.4% (95% IC: 40–64%) respectively. Conclusions These results suggest that urine samples processed with Cobas 4800 HPV test may be useful for clinical management of HPV infection.