Table 1.
Summary of results from repeatability and proficiency studies
| Study | Design summary | Molecular class calls (n) | Concordance | Bias discriminant scores between replicates (95% CI) | Discriminant score R2 |
|---|---|---|---|---|---|
| Inter-assay (consecutive days) | 16 samples, 1 instrument, 2 operators, 3 runs, 3 consecutive days, 1 manufacturing reagent lot | 48 | 100% | −0.0295 (−0.1809-0.1219) |
0.9944 |
| Inter-assay (long term) | 46 samples run on 2 separate days, 2 instruments, multiple runs, multiple operators, multiple manufacturing reagent lots | 92 | 100% | 0.0049 (−0.2816-0.2914) |
0.9747 |
| Intra-assay | 12 tumors with 2 replicates on 2 plates each, 1 instrument, 1 operator, 3 runs, 3 consecutive days, 1 manufacturing reagent lot | 48 | 100% | 0.0145 (−0.1182-0.1472) |
0.9934 |
| Inter-site | 29 samples, two instruments, two operators, 2 manufacturing reagent lots | 58 | 100% | 0.0233 (−0.1939-0.2405) |
0.9818 |
| Inter-operator/ instrument | 28 samples, 2 instruments, 2 operators, 2 runs, 1 day, 1 manufacturing reagent lot | 56 | 96% (C1 vs C2) 90% (C1A vs C1B) |
−0.0540 (−0.3266 -0.2186) |
0.9636 |