Table 3. Concordance between Idylla and other methods in detecting BRAF V600 mutations in formalin-fixed paraffin-embedded (FFPE) tumor tissue samples.
| Concordance between cobas and Idylla testing of FFPE tumor tissue samples (N = 58) | ||
|---|---|---|
| BRAF mutation (cobas) | BRAF wild-type (cobas) | |
| BRAF mutation (Idylla) | 13 | 2 |
| BRAF wild-type (Idylla) | 0 | 43 |
| Observed agreements | 56 (97%); kappa, 0.91, SE, 0.07; 95% CI, 0.78–1.00 | |
| Concordance between MiSeq and Idylla testing of FFPE tumor tissue samples (N = 58) | ||
| BRAF mutation (MiSeq) | BRAF wild-type (MiSeq) | |
| BRAF mutation (Idylla) | 15 | 0 |
| BRAF wild-type (Idylla) | 0 | 43 |
| Observed agreements | 58 (100%); kappa, 1.00, SE, 0.00; 95% CI, 1.00–1.00 | |
| Concordance between laboratory and Idylla testing of FFPE tumor tissue samples (N = 100) | ||
| BRAF mutation (CLIA) | BRAF wild-type (CLIA) | |
| BRAF mutation (Idylla) | 61 | 1 |
| BRAF wild-type (Idylla) | 3 | 35 |
| Observed agreements | 96 (96%); kappa, 0.91, SE, 0.04; 95% CI, 0.83–1.00 | |
| Sensitivity | 95% (95% CI, 0.87–0.99) | |
| Specificity | 97% (95% CI, 0.85–1.00) | |
| Positive predictive value | 98% (95% CI, 0.91–1.00) | |
| Negative predictive value | 92% (95% CI, 0.79–0.98) | |
Abbreviations: SE, standard error; CI, confidence interval.