Background: HPV urine testing has been proposed for monitoring impact of HPV vaccination, follow-up of treatment and/or reaching women not participating in cervical cancer screening programmes. The use of Colli-PeeTM (Novosanis) and UCM (Urine Collection Medium, UAntwerp, Belgium) has enhanced the analytical detection of HPV DNA in female urine. The Genefirst PapilloplexTM HR-HPV assay can genotype and quantify all 14 high risk types in a single closed tube real-time PCR reaction. The assay has been previously evaluated on liquid based cytology (LBC) cervical screening samples but not on urine samples for HPV detection.
Objectives: The aim of this study was to determine if Genefirst PapilloplexTM HR-HPV test is compatible with self-collected first void urine specimens. We compared the results of the PapilloplexTM HR -HPV test with results of the in-house real time type specific PCR used at AML and the Optiplex HPV genotyping Kit from DiaMex.
Methods: Women who had a self-reported prior HPV positive test result were enrolled in the study. 172 first void urine samples, provided by 22 women, were collected using either the Colli-PeeTM (Novosanis), first void urine collection device (n=86), or directly into a urine cup (n=86). The participants had to alternate the collection times (morning and late afternoon) over 4 consecutive days. Prior to the PCR tests four ml of urine/UCM mixture was concentrated on an ultrafiltration membrane and extracted with easyMag® (bioMérieux).
Results: There was substantial agreement for high risk HPV DNA positivity between the Genefirst results and the AML and DiaMex results. Respectively for AML/Genefirst and DiaMex/Genefirst an agreement of 86%; kappa 0.688 and agreement of 87.7%; kappa 0.705 was observed. The quantitative results are being analysed and will be presented at the meeting.
Conclusions: These preliminary results confirm that the PapilloplexTM HR-HPV assay is compatible with self-collected first void urine. Clinical cut-off determination will be addressed in future studies