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 change | Sensitivity, % (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.