Figure 5

Comparison with the international scale. (a) Bland and Altman analysis for the 20 samples tested with BCR/ABL1 Quant lot 1 at Asuragen Inc. and by the reference method at the IS Reference Laboratory. The graph shows the difference between methods (log IS percent ratio−log BCR/ABL1 Quant percent ratio) plotted against the average of both log percent ratio values. The mean difference between methods (bias, solid line) and the 95% limit of agreement between methods (95% LOA, dash lines) are shown. (b) Summary of results and assay performance during establishment and validation of the CF and for the combined data (overall). (c) Correlation plot between the IS percent ratios obtained with the BCR/ABL1 Quant assay and the reference method for samples within threefold to the MMR point (0.1% IS) according to the reference method. The equality line (solid line) and the fivefold limit of agreement between methods (dash lines) are shown. FN, false MMR negative; FP, false MMR positive; TN, true MMR negative; TP, true MMR positive.