Table 2 Prototype assay calibration performance summary using Fujirebio standard for assay evaluation and clinical test batches
Concentrationa (pg/ml) | ||||||||
|---|---|---|---|---|---|---|---|---|
Theoretical concentration | 0.023 | 0.069 | 0.206 | 0.617 | 1.85 | 5.6 | 16.7 | 50.0 |
Run 6 | −0.006 | 0.097 | 0.262 | 0.584 | 1.83 | 5.65 | 16.6 | 50.1 |
Run 7 | 0.112 | 0.365 | 0.514 | 1.94 | 5.36 | 17.1 | 49.8 | |
Run 8 | 0.260 | 0.283 | 0.388 | 1.98 | 5.79 | 16.0 | 50.5 | |
N (total number of runs) | 1 | 3 | 3 | 3 | 3 | 3 | 3 | 3 |
Inter-assay mean | −0.006 | 0.156 | 0.303 | 0.495 | 1.92 | 5.6 | 16.6 | 50.1 |
SD | 0.090 | 0.054 | 0.100 | 0.077 | 0.220 | 0.508 | 0.365 | |
CV% | 57.9 | 17.9 | 20.1 | 4.0 | 3.9 | 3.1 | 0.7 | |
Inter-assay RE, % | −125 | 128 | 47.5 | −19.8 | 3.6 | 0.8 | −0.7 | 0.3 |