FC 10-01PILOT STUDY ON USE OF INNO-LIPA® HPV GENOTYPING EXTRA II WITH COLLI-PEE COLLECTED UCM PRESERVED URINE

08. HPV testing
J. Pattyn 1, M. Dekoeijer 2, S. Van Keer 1, S. Biesmans 1, K. Beyers 2, V. Vankerckhoven 2, P. Van Damme 1, A. Vorsters 1.
1Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp (Belgium), 2Novosanis, Wijnegem (Belgium)

Background / Objectives

The INNO-LiPA HPV Genotyping Extra II assay can individually detect 32 HPV genotypes. Performance of this assay has been demonstrated on cervical scrapes, but no data are currently available regarding HPV DNA detection in first void urine. The aim of this pilot study is to determine whether the INNO-LiPA HPV Genotyping Extra II test is compatible with self-collected first void urine specimens.


Methods

18 Colli-PeeTM collected, preserved first void urine samples (16 HPV positive samples previously identified with the Riatol qPCR HPV genotyping assay (AML) and Multiplex HPV Genotyping assay (Diamex)) were analysed – samples originated from a cohort of women with self-reported prior HPV positive test results.

The participants collected the first void urine self-sample at home and sent the collection vial containing preservative uncooled by postal mail to the Antwerp University. Prior to the PCR tests 4 ml of urine/UCM mixture was concentrated on an ultrafiltration membrane and extracted with easyMAG® (bioMérieux).


Results

17/18 urine samples were successfully genotyped with the INNO-LiPA HPV Genotyping Extra II assay. An opened vial in the PCR instrument caused an invalid result for one sample. Two samples were HPV DNA negative as found by the Riatol qPCR HPV genotyping assay. For 13 out of the 15 remaining samples at least one high risk HPV type was detected by INNO-LiPA HPV Genotyping Extra II assay and confirmed by one or two of the other assays.


Conclusion

These preliminary results confirm that the INNO-LiPA HPV Genotyping Extra II assay is compatible with self-collected first-void urine. Confirmation of performance by testing larger series in a clinical setting is warranted.


References

1/ Vorsters, A., Van den Bergh, J., Micalessi, I., Biesmans, S., Bogers, J., Hens, A., De Coster, I., Ieven, M., and Van Damme, P. (2014). Optimization of HPV DNA detection in urine by improving collection, storage, and extraction. Eur J Clin Microbiol Infect Dis 33, 2005-2014.

2/ Vorsters, A., Van Damme, P., Clifford G. (2014). Urine testing of HPV: rationale for using first void. BMJ, 349:g5264