Genticel study
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Aim: Use of self-sampling devices for long-term follow-up of HPV infection
Partners: University of Antwerp (VAXINFECTIO), Novosanis nv
Results have been published in the International Journal of Molecular Sciences (2016;17(5),750) by Vorsters et al.
The impact of prophylactic vaccination programs and therapeutic vaccine trials can be monitored by the absence of persistent HPV infection. In this study, it was investigated if urine samples, which can be collected by self-sampling at home, instead of cervical samples can be used for follow-up of an HPV intervention trial.
Eighteen initially HPV DNA-positive women participating in an HPV therapeutic vaccine trial were monitored during a three-year follow-up period. A total of 172 urine samples and 85 cervical samples were collected. We obtained a paired urine sample for each of the 85 cervical samples by recovering urine samples from six monthly gynaecological examinations.
This small pilot study evaluated the use of a urine collection device at home and return of the urine sample to the laboratory by mail. Samples were analysed using quantitative real-time HPV DNA PCR.
Main results included:
- A good association (κ value of 0.65) was found between the presence of HPV DNA in urine and a subsequent cervical sample
- Comparisons of the number of HPV DNA copies in urine and paired cervical samples revealed a significant Spearman rho of 0.676. This correlation was superior in women with severe lesions.
The HPV DNA results of the small pilot study based on self-collected urine samples at home are consistent with previous and subsequent urine and/or cervical results. We demonstrated that urine sampling may be a valid alternative to cervical samples for the follow-up of HPV intervention trials or programs. The potential clinical value of urine viral load monitoring should be further investigated
