Table 3.
Concordance between IHCVentana versus STRAT4 and IHCVentana versus IHCDako
| Total study population | ||||||||
|---|---|---|---|---|---|---|---|---|
| Marker | IHCVentana+/STRAT4+ | IHCVentana−/STRAT4+ | IHCVentana+/STRAT4− | IHCVentana−/STRAT4− | Concordance OPA, % (95% CI) | Sensitivity PPA, % (95% CI) | Specificity NPA, % (95% CI) | Kappa statistic (95% CI) |
| ESR1/ER | 1045 | 0 | 12 | 19 | 98.9 (98.1% to 99.4%) | 98.9 (98.0% to 99.3%) | 100.0 (87.5% to 100.0%) | 0.76 (0.62% to 0.89%) |
| PGR/PR | 822 | 23 | 81 | 97 | 89.8 (87.8% to 91.5%) | 91.0 (89.0% to 92.7%) | 80.8 (72.9% to 86.9%) | 0.59 (0.53% to 0.66%) |
| ERBB2/HER2 | 41 | 1 | 18 | 1014 | 98.2 (97.3% to 98.9%) | 69.5 (56.9% to 79.7%) | 99.9 (99.4% to 100.0%) | 0.80 (0.72% to 0.89%) |
| MKi67/Ki67 | 158 | 66 | 9 | 260 | 84.8 (81.3% to 87.7%) | 94.6 (90.1% to 97.1%) | 79.8 (75.1% to 83.8%) | 0.69 (0.62% to 0.75%) |
| Tamoxifen plus aminoglutethimide arm | ||||||||
|---|---|---|---|---|---|---|---|---|
| Marker | IHCVentana+/IHCDako+ | IHCVentana−/IHCDako+ | IHCVentana+/IHCDako− | IHCVentana−/IHCDako− | Concordance OPA, % (95% CI) | Sensitivity PPA, % (95% CI) | Specificity NPA, % (95% CI) | Kappa statistic (95% CI) |
| ER | 508 | 0 | 6 | 11 | 98.9 (97.5% to 99.5%) | 96.6 (97.5% to 99.5%) | 100.0 (80.3% to 100.0%) | 0.78 (0.61% to 0.95%) |
| PR | 385 | 2 | 81 | 57 | 84.2 (80.8% to 87.1%) | 82.6 (78.9% to 85.8%) | 96.6 (88.5% to 99.1%) | 0.50 (0.41% to 0.59%) |
| HER2 | 32 | 7 | 0 | 466 | 98.6 (97.2% to 99.3%) | 100.0 (92.2% to 100.0%) | 98.5 (97.0% to 99.3%) | 0.89 (0.82% to 0.97%) |
| Ki67 | 48 | 0 | 16 | 155 | 92.7 (88.5% to 95.5%) | 75.0 (63.2% to 84.0%) | 100.0 (98.3% to 100.0%) | 0.81 (0.72% to 0.90%) |
CI, confidence interval; ER, estrogen receptor; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; ISH, in situ hybridization; NPA, negative percent agreement; OPA, overall percent agreement; PPA, positive percent agreement; PR, progesterone receptor.