BiR&D study

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Aim: Performance of a new first-void collection device

Partners: University of Antwerp (VAXINFECTIO, Product Development), Novosanis nv

Data was presented at the 29th IPV conference, 2014, Seattle via a poster.

Two groups were enrolled: Group A consisting of 32 women, ever positive for HPV16 and/or 18 at earlier testing, Group B consisting of 155 healthy volunteers (50 m, 105 f), with unknown HPV status. Participants tested the Colli-Pee™ and the Multi-Collect™ system on two consecutive days, all participants completed an online questionnaire. Group A send back their samples by mail, whereas Group B samples were collected at drop-off sites.

Main results included:

  • All group A samples arrived at the lab in good conditions
  • Group A: a significant better recovery of human DNA by Colli-Pee™, no significant difference for HPV DNA copies
  • The Colli-Pee™ device was reported more reliable and hygienic, appreciation for Colli-Pee™ was higher when the device was used standing in front of the toilet and no urine was spilled. 27% of the Multi-Collect™ vials was filled incorrectly
  • The amount of hDNA detected in male urine was significantly less than in women

To conclude, Colli-Pee™ collected urine by women provided more copies hDNA than the Multi-Collect™ from Abbott, a similar trend was observed for HPV DNA. Urine may not be the most appropriate sample for detecting HPV infection in men, as significant less hDNA copies and HPV DNA were observed in male urine.

Further research on the impact of vaccination on HPV DNA presence is needed, as in this study there was no impact observed in urine.