Table 2.
OPA, PPA, and NPA between PD-L1 assays
| Clinical algorithm | Comparator assay | VENTANA SP263 (TC/IC 25%) assay used as reference, % agreement (95% CI) a | ||
|---|---|---|---|---|
| OPA | PPA | NPA | ||
|
TC or ICICArea ≥ 25% (VENTANA SP263) |
PD-L1 IHC 22C3 pharmDx | 92.2% (89.4%) | 86.4% (80.1%) | 95.4% (92.3%) |
| PD-L1 IHC 28–8 pharmDx | 90.7% (87.7%) | 79.7% (72.6%) | 96.8% (94.0%) | |
| VENTANA SP142 | 85.7% (82.1%) | 64.4% (56.5%) | 97.2% (94.6%) | |
|
CPS ≥1 (PD-L1 IHC 22C3 pharmDx) |
PD-L1 IHC 22C3 pharmDx | 77.0% (72.9%) | 90.7% (85.0%) | 69.6% (64.0%) |
|
CPS ≥10 (PD-L1 IHC 22C3 pharmDx) |
PD-L1 IHC 22C3 pharmDx | 81.5% (77.6%) | 62.7% (54.8%) | 91.7% (87.9%) |
|
TC ≥1% (PD-L1 IHC 28–8 pharmDx) |
PD-L1 IHC 28–8 pharmDx | 75.5% (71.3%) | 66.9% (59.1%) | 80.2% (75.2%) |
|
ICTumorArea ≥ 5% (VENTANA SP142) |
VENTANA SP142 | 69.9% (65.5%) | 15.3% (10.1%) | 99.5% (97.8%) |
a For each metric, lower boundary of 95% confidence interval (CI) was calculated with no upper bound using the Clopper–Pearson method [37]
CPS combined positive score, IC immune cell, IHC immunohistochemistry, NPA negative percentage agreement, OPA overall percentage agreement, PD-L1 programmed cell death ligand-1, PPA positive percentage agreement, TC tumor cell