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.