P12-16PILOT FEASIBILITY STUDY ON USE OF THE XPERT HPV ASSAY WITH COLLI-PEE COLLECTED, UCM PRESERVED URINE.

10. HPV testing
A. Vorsters 1, V. Vankerckhoven 2, S. Van Keer 1, S. Biesmans 1, K. Beyers 2, M. De Koeijer 2, H. Revets 1, P. Van Damme 1.
1University of Antwerp, VAXINFECTIO (Belgium), 2Novosanis (Belgium)

Background / Objectives

HPV testing in urine has been proposed for monitoring impact of vaccination, follow-up of treatment and/or reaching women not participating in a cervical cancer screening programme.  The use of Colli-PeeTM (Novosanis, Belgium) and UCM (Urine Collection Medium, UAntwerp, Belgium) has enhanced the analytical detection of HPV DNA in female urine. The Xpert®HPV assay (Cepheid, Sunnyvale) has been validated to detect HPV DNA in cervical samples, but no data are currently available regarding HPV DNA detection in urine.

The aim of this study was to determine if the Xpert HPV assay is compatible with Colli-PeeTM collected, UCM preserved urine. 


Methods

Fifteen Colli-PeeTM collected, UCM preserved urine samples were analysed. These samples originated from a cohort of women participating in a therapeutic HPV vaccination trial and were characterised by an in-house HPV type specific (TS) qPCR method (UAntwerp, Belgium). The samples were collected by the participants at home and were send uncooled by mail to the University of Antwerp.


Results

This pilot study demonstrates that the GeneXpert® platform (Cepheid, Sunnyvale) performs well with the Colli-PeeTM collected, UCM preserved urine samples. HPV DNA was detected by the Xpert HPV assay in most of the HPV positive samples.

A correlation between the Ct (cycle threshold) values obtained with Xpert HPV and the in-house TS qPCR is observed for human DNA and HPV DNA. This further confirms the compatibility of the Cepheid platform and Colli-PeeTM collected, UCM preserved urine. We did find some indications of a lower analytical sensitivity for HPV DNA, but for screening purposes this may even be an advantage to obtain the required clinical performance. All samples with a Ct value below 35 in our in-house TS qPCR for HPV 16 and/or 18 were also positive with the Xpert HPV assay.


Conclusion

These results are very encouraging to further investigate the performance of first void collected, UCM preserved urine in combination with Xpert®HPV. Especially, as both the collection and the detection system can function outside the cold chain, this may lead to innovative HPV testing opportunities in low-resource and point-of-care settings.  


References