转换国际标准化的BCR-ABL(P210)转录本水平的转换系数多中心再确认研究

OBJECTIVE: To revalidate the conversion factor (CF) for the conversion of BCR-ABL(P210) transcript levels to the international scale (BCR-ABL(IS)) in chronic myeloid leukemia (CML) which validated before. METHODS: Peking University People's Hospital (PKUPH) prepared the exchange samples for revalidation of CFs of 15 laboratories which validated nine or eighteen months ago. The fresh BCR-ABL (P210) (+) bone morrow or peripheral blood nucleated cells were diluted with BCR-ABL (P210) (−) cells to achieve different BCR-ABL levels, totally 16 sets and 24 samples per set were prepared. TRIzol reagent was added in each tube. Each laboratory tested BCR-ABL transcript levels of one set of samples. Agreement between BCR-ABL(IS) of each laboratory and PKUPH was assessed by the Bland-Altman method. For laboratories which did not meet the criteria of revalidation, linear regression equation was derived after the samples with maximum BCR-ABL deviation were removed until R(2)>0.98, then new CF was calculated. RESULTS: 10 laboratories met the revalidation criteria with both bias within ± 1.4 fold and 95% limits of agreement within ±6 folds, and their CFs still could be used for accurately conversion of BCR-ABL(IS). New CFs were recalculated as of 1.8–6.3 folds of their previous CFs in 5 laboratories not met the criteria. CONCLUSION: Revalidation of CF by sample exchange among laboratories was necessary for accurate and continuous application of BCR-ABL(IS), which not only tested the validity of CF acquired before but also calculated new available CFs for those with invalid CFs.