Genefirst-Papilloplex™ HR-HPV study

Aim: Compatibility of the Genefirst PAPILLOPLEX™ HR-HPV genotyping assay for testing first-void urine specimens

Partners: Genefirst, University of Antwerp (VAXINFECTIO), Novosanis nv

Results from the Proof of Concept study were presented via a poster at the Eurogin conference, June 2016, Salzburg.

Samples from the IWT study: 22 HPV-positive women were included and each collected 8 UCM-preserved urine samples on 4 consecutive days (morning and late afternoon), using either the Colli-Pee™ or a regular urine cup. Therefore, 172 first-void urine samples were obtained, of which 88 Colli-Pee™ and 88 urine cup. DNA was extracted in-house and analyzed in-house (HPV 16 and human DNA TS qPCR), at AML (TS qPCR), at Heidelberg (HPV genotyping DiaMex), and using the Papilloplex™ HR-HPV assay.

Main results included:

• Good agreement of 0.676 and 0.669 of Papilloplex™ HR-HPV assay with AML TS qPCR and Optiplex HPV genotyping kits respectively for the HR HPV genotypes
• High positive correlation recorded for the CT values from our in-house human DNA (GADPH) qPCR and the human DNA control of the Papilloplex™ HR-HPV assay (R²=0.738)
• Very high positive correlation for HPV16 DNA Ct values between the two assays (R²=0.919)
• Average Ct values reported in Colli-Pee collected urine for human DNA and HPV DNA found to be lower than the Ct values from urine cup collected samples, which implicates a higher analytical sensitivity

It was concluded that the Papilloplex™ HR-HPV assay is compatible with self-collected urine. Colli-Pee collected first-void contains higher concentrations of human and HPV DNA compared to urine cup collected first-void urine.

Future studies will focus on clinical cut-off determination and demonstration of assay performance in larger studies