Table 1B.
Summary of results from all studies (combined estimate of sensitivity and specificity)
| TPS Cut-off | Gold Standard | Candidate Assay | No. of Comparisons | Sensitivity (95% CI) | Specificity (95% CI) |
|---|---|---|---|---|---|
| 1% | PD-L1 IHC 22C3 pharmDx | 22C3 LDT | 11 | 0.99 (0.91 -1.00) | 1.00 (0.78–1.00) |
| PD-L1 IHC 28-8 pharmDx | 21 | 0.96 (0.92–0.97) | 0.84 (0.78–0.88) | ||
| Ventana PD-L1 (SP263) | 16 | 0.93 (0.88–0.95) | 0.83 (0.77–0.86) | ||
| E1L3N LDT | 14 | 0.84 (0.78–0.88) | 0.94 (0.90–0.96) | ||
| Ventana PD-L1 (SP142) | 18 | 0.61 (0.55–0.67) | 0.97 (0.94–0.98) | ||
| 28-8 LDT | 6 | See Table B | |||
| SP142 LDT | 3 | See Table C | |||
| SP263 LDT | 2 | See Table C | |||
| 73-10 Assay | 1 | See Table C | |||
| PD-L1 IHC 28-8 pharmDx | Ventana PD-L1 (SP263) | 14 | 0.90 (0.86–0.94) | 0.88 (0.82–0.93) | |
| PD-L1 IHC 22C3 pharmDx | 24 | 0.88 (0.84–0.91) | 0.94 (0.92–0.96) | ||
| 28-8 LDT | 4 | 0.82(0.67–0.91) | 0.91 (0.82–0.96) | ||
| E1L3N LDT | 12 | 0.80 (0.76–0.84) | 0.99 (0.94–0.99) | ||
| Ventana PD-L1 (SP142) | 13 | 0.59 (0.52–0.66) | 0.99 (0.96–1.00) | ||
| SP142 LDT | 2 | See Table C | |||
| SP263 LDT | 2 | See Table C | |||
| 73-10 Assay | 1 | See Table C | |||
| Ventana PD-L1 (SP263) | PD-L1 IHC 28-8 pharmDx | 14 | 0.93 (0.86–0.96) | 0.85 (0.80–0.88) | |
| PD-L1 IHC 22C3 pharmDx | 17 | 0.83 (0.76–0.89) | 0.91 (0.85–0.94) | ||
| E1L3N LDT | 9 | 0.78 (0.71–0.84) | 0.93 (0.88–0.96) | ||
| Ventana PD-L1 (SP142) | 13 | 0.58 (0.51–0.66) | 0.98 (0.96–0.99) | ||
| 28-8 LDT | 4 | See Table B | |||
| SP142 LDT | 1 | See Table C | |||
| 73-10 Assay | 1 | See Table C | |||
| 22C3 LDT | 1 | See Table C | |||
| 50% | PD-L1 IHC 22C3 pharmDx | 22C3 LDT | 10 | See Table B | |
| PD-L1 IHC 28-8 pharmDx | 21 | 0.94 (0.88–0.97) | 0.95 (0.93–0.97) | ||
| 28-8 LDT | 6 | 0.95 (0.81–0.99) | 0.76 (0.67–0.83) | ||
| Ventana PD-L1 (SP263) | 16 | 0.92 (0.84–0.96) | 0.92 (0.90–0.94) | ||
| E1L3N LDT | 13 | 0.76 (0.62–0.86) | 0.97 (0.95–0.99) | ||
| Ventana PD-L1 (SP142) | 17 | 0.42 (0.31–0.54) | 1.00 (0.99–1.00) | ||
| SP142 LDT | 3 | See Table C | |||
| SP263 LDT | 1 | See Table C | |||
| 73-10 Assay | 1 | See Table C | |||
| Ventana PD-L1 (SP263) | 28-8 LDT | 4 | See Table B | ||
| PD-L1 IHC 28-8 pharmDx | 13 | 0.69 (0.56–0.79) | 0.98 (0.96–0.99) | ||
| PD-L1 IHC 22C3 pharmDx | 17 | 0.57 (0.46–0.68) | 0.99 (0.98–1.00) | ||
| E1L3N LDT | 9 | 0.36 (0.28–0.44) | 0.99 (0.93–1.00) | ||
| Ventana PD-L1 (SP142) | 10 | See Table B | |||
| SP142 LDT | 1 | See Table C | |||
| 22C3 LDT | 1 | See Table C | |||
| 73-10 Assay | 1 | See Table C | |||