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Performance of a new first-void urine collection device

Novosanis
Novosanis
Mar. 12, 2015
Performance of a new first-void urine collection device
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Performance of a new first-void urine collection device

  1. Performance of a new first-void urine collec on device 1 Vaccine & Infec ous Disease Ins tute, University of Antwerp, Belgium | 2 Novosanis NV, Antwerpen | 3 Antwerp University Hospital, Antwerpen, Belgium 1 1 1 2 2 2 1,3 1 Vorsters A | Biesmans S | Vanderborght C | Van Mulder T | Vankerckhoven V | Beyers K | Ieven M | Van Damme P Methods Importance of collec ng the first part of a urine void (first void) and 1 adequatelypreservingthe DNA hasbeenreportedpreviously. Inthisstudy we evaluate a prototype of a new first-void urine collec on device (Colli TM Pee , Novosanis) and a self-sampling method using urine collec on vials TM (Mul -Collect ,Abbo ). Introduc on and objec ves: GroupA: 32women,everposi vefor HPV16and/or18atearlier tes ng(HPV DNA oncervicalsample); Group B: 155 healthy volunteers (50 ♂/ 105 ♀), HPV status not know. Par cipants group A and B enrolled to test each device (Figure 1) at home ontwoconsecu vedays;allpar cipantscompletedonlineques onnaire. Transport of samples: Group A received and returned the sampling devices by mail. For group B specific collect and drop-off sites at the universitywereorganized. HPV andhDNA detec on: Group A urine samples (obtained through both collec on systems): HPV DNA and hDNA were quan fied by real- me PCR and all samples were testedbyMul plex HPV genotypingkit,DiaMex,Heidelberg,Germany. Group B urine samples (obtained through Colli-Pee™): hDNA and HPV quan fica on as well as HPV detec on and genotyping by Mul plex HPV genotyping kit was performed. Prior to automated DNA extrac on the total DNA, i.e. cell associated, viral and free DNA was recovered using ultra-filtra on. Sta s calanalysiswasdonein SPSS 20. Figure 1: Two different urine collec on methods In women, urine collected by the Colli-Pee™ method provided more copies hDNA than the Mul -Collect™ from Abbo . Although the difference was notsignificant,asimilartrendwasobservedfor HPV DNA. Urine may not be the most appropriate sample for detec ng HPV infec on in men. Significant less hDNA copies and HPV DNA were observed in the maleurine. Impact of vaccina on on HPV DNA presence in urine was not observed. This could be due to the fact that the current cohort of women was vaccinated a er contrac ng HPV infec on. Further research is needed to confirmthis. All samples including the samples of group A arrived at the lab in good condi on. Figure 2 shows that in group A a significant be er recovery of hDNA was obtained by the Colli-Pee™; no significant difference was observedfordetec onof HPV DNA copies. Discussion and conclusion Results 10 1.000 10.000 100.000 1.000.000 10 1.000 10.000 100.000 1.000.000 copies HPV DNA a Collec on methodCollec on method copies hDNA Mul -Collect™ Colli-pee™ NS Par cipants reported that the Colli-Pee™ device was more reliable and hygienic. Overall, apprecia on for Colli-Pee™ was higher when the device was used standing in front of the toilet and no urine was spilled. Of note, 27%oftheMul -Collect™vialswerefilledincorrectly. Table 1 shows that 20% of the women in group B was posi ve for one or moreofthe HPV genotypesdetectedbytheMul plex HPV genotypingkit. Only 4% of the men had detectable HPV DNA. The amount of hDNA detected in the male urine, 1597 copies/µl DNA extract, was significantly lessthaninwomen,40414copies/µl DNA extract(p=0.001; T-test). Novosanis is a spin-off company of the University of Antwerp. VA, VKV, BK, and VDP are co-founders of Novosanis. Disclosure Reference: 1. A. Vorsters, J. Van den Bergh, I. Micalessi, S. Biesmans, J. Bogers, A. Hens, I. De Coster, M. Ieven, P. Van Damme. Op miza on of HPV DNA detec on in urine by improving collec on, storage, andextrac on.EurJClinMicrobiolInfectDis.2014;availableonline, DOI 10.1007/s10096-014-2147-2. Table 1: Group B: HPV DNA posi vity determined by Mul plex HPV genotyping kit in Colli-Pee™ collected urine samples from 155 healthy volunteers. Table 2: Group B: HPV DNA status in vaccinated and non-vaccinated women <27y. Colli-Pee™ Mul -Collect™ contact: alex.vorsters@uantwerpen.be p=0.001 Wilcoxon* p=0.109 Wilcoxon Figure 2: Group A: comparison of HPV DNA copies (n=16) and hDNA (n=32) found in urine samples collected through Mul -Collect™ or Colli-Pee™ a: 15 of the Colli-Pee™ samples and 14 of the Mul -Collect™ collected samples were HPV 16 DNA posi ve. Samples nega ve for both methods are not included in boxplot; NS not significant; * significant. * Table 2 shows the HPV DNA and vaccina on status in women under 27 years in group B. 33 (43.4%) of the 76 women reported to be vaccinated. No significant impact of the reported vaccina on status was observed on the presence of HPV DNA. Of note, 7 of the 36 men under 27y were not aware of their vaccina on status. HPV DNA neg HPV DNA pos 48 (96%) 84 (80%) 2 (4%) 21 (20%) Men Womena HPV DNA neg HPV DNA pos 50 24 6 9 Not vaccinated Vaccinated b HPV DNA neg HPV DNA pos 40 29 1 4 a: significant difference between HPV posi vity in females and males. (p= 0.008, Fisher’s exact test). b: Vaccina on status was self reported, 2 women did not know their vaccina on statusandarenotincludedinthetable.They wereboth HPV DNA nega ve. Transport Tube with urine fill window Transfer Pipe e Mul -Collect™ Colli-pee™ 29th IPV Conference, 2014, Sea le, US, Poster #PH.PP02.114
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