Cepheid-Xpert® HPV study

Aim: Feasibility study on use of the GeneXpert HPV Assay with Colli-Pee™ collected, UCM preserved urine

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

Results from the pilot feasibility study were presented via a poster at the Eurogin conference, June 15-18 2016, Salzburg.

15 Colli-Pee™ collected, UCM buffer preserved urine samples were analyzed on the Cepheid Xpert® HPV and using the in-house HPV PCR method.

Main results included:

• High correlation between human DNA quantities found using both methods (R²=0.533)
• Very high correlation for HPV 16 DNA quantities found using both methods (R²=0.928)
• Good agreement between the analytical methods.

Therefore, it was concluded that:

• Results are very encouraging to further investigate the performance of first-void collected, UCM preserved urine in combination with Xpert® HPV.
• As both the collection and the detection system can function outside the cold chain, this may lead to innovative HPV testing opportunities in low-resource and point-of-care settings.

In the discussion, it was stressed that the Xpert® HPV is optimized for the use of cervical samples, discrepant results are partly explained by the limited amount of HPV DNA that is present in urine. The slightly lower analytical sensitivity observed with the Cepheid assay may not be of relevance in a clinical setting.