Table 2.
Analytical evaluation of concordance between SP142, SP263, and 22C3 assays
| Agreement | SP263 |
22C3 |
22C3 |
||||||
|---|---|---|---|---|---|---|---|---|---|
| IC <1% | IC ≥1% | Total | IC <1% | IC ≥1% | Total | CPS <1 | CPS ≥1 | Total | |
| SP142 | |||||||||
| IC <1%, no. (%a) | 147 (23.9) | 182 (29.6) | 329 | 151 (24.6) | 178 (29.0) | 329 | 111 (18.1) | 218 (35.5) | 329 |
| IC ≥1%, no. (%a) | 7 (1.1) | 278 (45.3) | 285 | 14 (2.3) | 271 (44.1) | 285 | 6 (1.0) | 279 (45.4) | 285 |
| Total, no. | 154 | 460 | 614 | 165 | 449 | 614 | 117 | 497 | 614 |
| Positive percentage agreement | |||||||||
| no./N | 278/285 | 271/285 | 279/285 | ||||||
| % (95% CI) | 97.5 (95.7 to 99.3) | 95.1 (92.6 to 97.6) | 97.9 (96.2 to 99.6) | ||||||
| Negative percentage agreement | |||||||||
| no./N | 147/329 | 151/329 | 111/329 | ||||||
| % (95% CI) | 44.7 (39.3 to 50.1) | 45.9 (40.5 to 51.3) | 33.7 (28.6 to 38.8) | ||||||
| Overall positive agreement | |||||||||
| no./N | 425/614 | 422/614 | 390/614 | ||||||
| % (95% CI) | 69.2 (65.6 to 72.9) | 68.7 (65.1 to 72.4) | 63.5 (59.7 to 67.3) | ||||||
a
Calculated based on the total number of biomarker-evaluable patients. CI = confidence interval; CPS = combined positive score; IC = tumor-infiltrating immune cells.