Performance and Diagnostic Accuracy of a Urine-Based Human Papillomavirus Assay in a Referral Population
Cancer Epidemiology, Biomarkers and Prevention
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Background HPV testing from clinician-collected cervical and self-collected cervico-vaginal samples is more sensitive for detecting CIN2+/CIN3+ than cytology-based screening, stimulating interest in HPV testing from urine. The objective was to determine the performance of the Trovagene HPV test for the detection of CIN2+ from urine and PreservCyt cervical samples. Methods Women referred for colposcopy at St Mary’s Hospital London, following abnormal cytology, were recruited to this diagnostic accuracy study by convenience sampling (September 2011 and April 2013). 501 paired urine and cervical samples were collected. Primary outcome: sensitivity for CIN2+/CIN3+; specificity for <CIN2. Secondary outcomes: comparisons with other HPV tests; agreement/kappa values between urine and cervical samples. Results Trovagene HPV test sensitivity and specificity from PreservCyt were similar to well-established tests [sensitivity for CIN3+(n=145) 96·3%(95%CI,89·6-99·2); CIN2+(n=81) 94·5%(95%CI,89·4-97·6); specificity for <CIN2 25·3%(95%CI,20·8-30·1)]. Sensitivity from urine was slightly, but not significantly lower [CIN3+ 91·4%(95%CI,83·0-96·5), P=0·3; CIN2+ 88·3%(95% CI,81·9-93·0), P=0·06]. Specificity for <CIN2 was similar: 24·7%(95%CI,20·3-29·5), P=0·9. 403 Trovagene HPV tests were positive and 396 urine tests. Overall agreement between paired samples was 82·6%(95%CI,79·3-86·0). Conclusion 4 Trovagene HPV test’s performance on PreservCyt cervical samples was comparable to established HPV tests. Sensitivity in urine although slightly lower may nevertheless be adequate for selfsampling. This referral population’s higher HPV positivity rate affects specificity, warranting further studies in a screening population. Impact This may prove useful for women not attending for cervical screening.