Roche-COBAS® HPV study

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Aim: Evaluation of the Roche COBAS® HPV Assay with Colli-Pee collected, UCM preserved urine

Partners: Roche, Anacura, University of Antwerp (VAXINFECTIO), Novosanis nv

Results from the first evaluation study were presented via a poster at the Eurogin conference, June 2016, Salzburg.

44 Colli-Pee™ collected, UCM preserved urine samples were analyzed on the Roche COBAS®HPV assay and using the in-house HPV PCR method. 32 samples originated from a cohort of women participating in a therapeutic HPV vaccination trial, 12 positive samples from previous trials were added.

Main results included:

  • All samples were positive for the Roche beta-globin internal control signal
  • High positive correlations between Ct values obtained by in-house human DNA (GAPDH) PCR and the Roche beta-globin internal control Ct values
  • Very high positive correlation for Ct values of HPV 16 DNA

It was therefore concluded that the Cobas®Roche assay is compatible with Colli-Pee™ collected, UCM preserved urine. The results are very encouraging to further investigate possible applications of first-void urine in combination with the Roche Cobas®HPV assay.

Sensitivity of the Roche Cobas® assay has been set for detection of clinical relevant infections in cervical samples and may be substantially increased when modifying the internal threshold.