Study outline | Design | NSCLC results, % (95Â % CI) |
---|---|---|
Intra-day: performance within a single run on a BenchMark ULTRA instrument | 10 cases 5 PD-L1 high 5 PD-L1 low/negative n = 100 | PPA 100.0 (88.6–100.0) NPA 100.0 (83.9–100.0) OPA 100.0 (92.9–100.0) |
Inter-day: performance on the same BenchMark ULTRA instrument over 5 non-consecutive days for a minimum of 20 days | 10 cases 5 PD-L1 high 5 PD-L1 low/negative n = 50 | PPA 100.0 (92.9–100.0) NPA 96.0 (86.5–98.9) OPA 98.0 (93.0–99.4) |
Intermediate precision: Inter-antibody lot (n = 3 lots) | 18 cases 9 PD-L1 high 9 PD-L1 low/negative PPA & NPA n = 243 OPA n = 486 | PPA 99.2 (97.0–99.8) NPA 97.5 (94.7–98.9) OPA 98.4 (96.8–99.2) |
Intermediate precision: Inter-detection kit lot (n = 3 lots) | 18 cases 9 PD-L1 high 9 PD-L1 low/negative PPA & NPA n = 243 OPA n = 486 | PPA 99.2 (97.0–99.8) NPA 97.9 (95.3–99.1) OPA 98.6 (97.1–99.3) |
Intermediate precision: Intra-platform (n = 3 instruments) | 18 cases 9 PD-L1 high 9 PD-L1 low/negative PPA & NPA n = 243 OPA n = 486 | PPA 99.2 (97.0–99.8) NPA 97.5 (94.7–98.9) OPA 98.4 (96.8–99.2) |