Table 3

An increase in BCR-ABL RNA above a variable cutoff threshold predicts the presence of a concomitant KD mutation

RQ-PCR increase, fold changeSensitivity, % (95% CI)Specificity, %Negative predictive value, % (95% CI)Odds ratio (95% CI)P
2.0 77 (62-88) 44 88 (80-94) 2.6 (1.2-5.4) .01 
2.5 77 (62-88) 46 89 (81-94) 2.8 (1.4-5.9) .005 
2.6 77 (62-88) 47 89 (81-94) 2.9 (1.4-6.0) .005 
2.6* (include subsequent sample) 94 (82-99) 47 97 (91-99) 13 (3.9-43) < .001 
3.0 74 (60-86) 48 88 (80-94) 2.7 (1.3-5.5) .008 
3.5 64 (49-77) 54 86 (78-91) 2.1 (1.1-4.1) .03 
4.0 60 (44-74) 60 85 (78-91) 2.2 (1.1-4.2) .02 
4.5 55 (40-70) 64 85 (78-90) 2.2 (1.2-4.2) .02 
5.0 47 (32-62) 68 84 (77-89) 1.9 (1.0-3.6) .06 
10 26 (14-40) 83 82 (75-87) 1.7 (0.8-3.7) .2 
RQ-PCR increase, fold changeSensitivity, % (95% CI)Specificity, %Negative predictive value, % (95% CI)Odds ratio (95% CI)P
2.0 77 (62-88) 44 88 (80-94) 2.6 (1.2-5.4) .01 
2.5 77 (62-88) 46 89 (81-94) 2.8 (1.4-5.9) .005 
2.6 77 (62-88) 47 89 (81-94) 2.9 (1.4-6.0) .005 
2.6* (include subsequent sample) 94 (82-99) 47 97 (91-99) 13 (3.9-43) < .001 
3.0 74 (60-86) 48 88 (80-94) 2.7 (1.3-5.5) .008 
3.5 64 (49-77) 54 86 (78-91) 2.1 (1.1-4.1) .03 
4.0 60 (44-74) 60 85 (78-91) 2.2 (1.1-4.2) .02 
4.5 55 (40-70) 64 85 (78-90) 2.2 (1.2-4.2) .02 
5.0 47 (32-62) 68 84 (77-89) 1.9 (1.0-3.6) .06 
10 26 (14-40) 83 82 (75-87) 1.7 (0.8-3.7) .2 
*

Except for the indicated row, table includes only those patients with successful RQ-PCR and sequencing performed on the same sample. If samples after the initial genotype determination are included, at the optimal 2.6-fold cutoff, the sensitivity, negative predictive value, and odds ratio increase.

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