BD-Onclarity™ study
You are here
Aim: Performance of an automated HPV genotyping assay using first-void urine
Partners: BD Diagnostics, University of Antwerp (VAXINFECTIO), Novosanis nv
Results from the pilot feasibility study were presented via a poster at the IPV conference, September 2015, Lisbon.
Samples from IWT study: 21 women collected urine samples in the morning at afternoon on 4 consecutive days (8 samples per participant). Sample processing with the BD Viper LT automated assay and semi-automated reference method were compared, as well as samples from Colli-Pee™ compared to regular urine collector, and the comparison of morning and evening urine.
Main results included:
- Performance of both systems was very similar, with a good reproducibility in detecting human and viral DNA. Both single and mixed infections were reliably detected in serially collected specimens from the same patients.
- Colli-Pee™ collected urine showed a better detection on the Onclarity assay than samples collected with a urine cup (lower Ct values and more positive signals). A higher kappa value between both detection methods is observed from Colli-Pee™ collected urine.
- Using the Onclarity assay, a slight significant improvement in Ct scores between morning and later afternoon urine was found
Main advantages of the BD Viper LT automated assay are higher throughput and minimal hands on time, while proving a similar performance. The BD Onclarity™ HPV Assay reliably detects HPV in urine specimens and offers the potential of a high quality and high ease of use sample type for HPV screening.
Clinical cut-off determination versus CIN2+ histology endpoints will be addressed in future studies.
