As part of the Valid-screen project, a grant of the EU in the Horizon 2020 program, the QIAsure Methylation Test was tested for its reproducibility. Results have been published in Journal of Clinical Laboratory Analysis: Floore et al, J Clin Lab Anal. 2019.
A study with the six collaborating European laboratories in the Valid-screen project and a reference laboratory was set out to determine the intra- and inter-laboratory agreement of the QIAsure Methylation Test. Intra- and inter-laboratory assay agreement were 91.4% (534/584; 95%CI 88.9-93.5; kappa value of 0.82) and 92.5% (369/399; 95%CI 90.0-94.7; kappa value of 0.83), respectively. The inter-laboratory workflow (bisulfite conversion and assay combined) agreement was 90.0% (627/697; 95%CI 87.5% – 92.0%; kappa value of 0.76).
These data show that the QIAsure Methylation Test performs robust and reproducible in different laboratory contexts. These results support the use of the QIAsure Methylation Test for full molecular screening for cervical cancer, including primary HPV testing and triage testing by methylation analysis.