Urine testing as a surveillance tool to monitor the impact of HPV immunization programs.

HPV surveillance is necessary to monitor the impact and success of HPV immunization programs. This study was designed to evaluate the performance of HPV testing in urine to assess its suitability for epidemiological and surveillance purposes. A total of 90 females and 117 males were recruited from a UK drop-in clinic offering integrated sexual health services. A urine sample and comparator gold-standard sample (cervical liquid-based cytology sample or penile swab) was collected from each subject. HPV detection was performed using a PCR-based assay. Discrepancy between the two overall distributions [urine vs. gold standard (GS)] was measured. At the individual level, sensitivity and specificity of HPV detection in urine versus GS was measured. Prevalence of HPV was higher in urine compared to GS in both females and males. At the individual level, sensitivity of urine versus GS for HPV detection was 90.5% (79.3-96.9) and 55.9% (37.8-72.8) in females and males, respectively. The overall distribution of HPV types in urine was similar to that in gold standard, (P = 0.78; male, P = 0.88; female). Type-specific matches in urine versus GS were achieved in 71% (61-79.5) and 63.2% (54.2-71.4) of samples from females and males, respectively. Urine, particularly from females, is a useful biospecimen for HPV surveillance purposes. Further examination into the usefulness of urine from males, including choice of relevant gold-standard comparator, is required.