Table 2.
Limit of blank: data for the 12 participating laboratories.
| Lab | A | B | C | D | E | F | G | H | I | J | K | L |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Final BCR::ABL1 LoB (95%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.41 | 2.35 | 2.57 |
| Final BCR::ABL1 LoB (90%) | – | – | – | – | – | – | – | – | – | 0 | 0.6 | 2.17 |
| Final BCR::ABL1 LoB (85%) | – | – | – | – | – | – | – | – | – | – | 0 | 1.95 |
| Final BCR::ABL1 LoB (50%) | – | – | – | – | – | – | – | – | – | – | – | 0.79 |
| Total BCR::ABL1 replicates | 120 | 120 | 120 | 120 | 120 | 120 | 90 | 120 | 120 | 120 | 120 | 120 |
| No. of negative BCR::ABL1 replicates | 120 | 120 | 120 | 120 | 120 | 120 | 90 | 119 | 119 | 117 | 110 | 3 |
| % Negative BCR::ABL1 replicates | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 99.2 | 99.2 | 97.5 | 91.7 | 2.5 |
| Max BCR::ABL1 copy number | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.44 | 2.15 | 2.67 | 2.9 | 4.25 |
Laboratories A–I have a likelihood of ≤5% that a true BCR::ABL1 negative sample will give a result greater than zero. Laboratories J, K, and L have a likelihood ranging from 10–50% (indicated in bold) that a true BCR::ABL1 negative sample will give a result greater than zero.