Table 4.
Operational analysis of two-step KRAS mutation testing of 120 CRC samples
| Run 1 | Run 2 | Summary | ||||
|---|---|---|---|---|---|---|
| HRM | n | % | n | % | n | % |
| Number of samples | 120 | 100.0 | 20 | 100.0 (16.7) | 120 | 100.0 |
| Analysis passed | 89 | 74.2 | 18 | 90.0 | 105 | 87.5 |
| WT (total) | 60 | 67.4 | 12 | 66.7 | 71 | 67.6 |
| WT (skewed HRM curve) | 3 | 5.0 | 2 | 16.7 | 4 | 5.6 |
| Mutant (total) | 29 | 32.6 | 6 | 33.3 | 34 | 32.4 |
| Mutant (skewed HRM curve) | 1 | 3.4 | 1 | 16.7 | 1 | 2.9 |
| Analysis failed | 31 | 25.8 | 2 | 10.0 | ||
| Pyrosequencing | n | % | n | % | n | % |
| Number of samples | 19 | 100.0 (15.8) | 3 | 100.0 (2.5) | 19 | 100.0 |
| Analysis passed | 18 | 94.7 | 2 | 66.7 | 18 | 94.7 |
| WT | 12 | 66.7 | 0 | 0.0 | 13 | 72.2 |
| Potential low level mutation | 2 | 11.1 | 1 | 50.0 | 0 | 0.0 |
| Mutant | 4 | 22.2 | 1 | 50.0 | 5 | 27.8 |
| Analysis failed | 1 | 5.3 | 1 | 33.3 | 1 | |
| Combined HRM + Pyrosequencing | n | % | ||||
| Number of samples | 120 | 100.0 | ||||
| Number of HRM runs | 140 | 116.7 | ||||
| Number of pyrosequencing runs | 22 | 18.3 | ||||
| Analysis passed | 119 | 99.2 | ||||
| WT | 81 | 68.1 | ||||
| Mutant | 38 | 31.9 | ||||
| Analysis failed | 1 | 0.8 | ||||