Real time Quantitation Polymerase Chain Reaction (RQ-PCR) for the BCR-ABL1 transcript is a vital tool in the monitoring of BCR-ABL1 positive leukaemia patients receiving Tyrosine Kinase Inhibitor (TKI) therapy. The IRIS study shows that a Major Molecular Response in BCR-ABL1 levels, equivalent to 0.1% on the International reporting Scale (IS), equates to better overall outcome. European Leukaemia Net (ELN) guidelines classify optimal response to treatment as the achievement of MMR by 18 months.
In this programme participants are provided with lyophilised cell-lines for quantitative BCR-ABL1 analysis. Participants are asked to submit quantitative results, either as %BCR-ABL1/control gene or %BCR-ABL1/control gene on the international scale (IS) together with details of the methodology. Instructions for the storage, reconstitution and use of the lyophilised samples are included with the samples. Three send-outs are issued per annum, with each send-out consisting of two samples.
No activities in relation to this EQA programme are subcontracted.