Skip to main content

Table 4 PD-L1 (SP263) assay performance test results

From: Development of a programmed cell death ligand-1 immunohistochemical assay validated for analysis of non-small cell lung cancer and head and neck squamous cell carcinoma

Study outline Design NSCLC results, % (95 % 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)
  1. CI confidence interval, NPA negative percentage agreement, NSCLC non-small cell lung cancer, OPA overall percentage agreement, PD-L1 programmed cell death ligand-1, PPA positive percentage agreement