Parameter | Acceptance criteria | VAMP2 ELISA | SNAP25 Simoa | ||||||
---|---|---|---|---|---|---|---|---|---|
Sensitivity – LLOQ Conc | Meanblank + 10*SDblank | 127 pg/ml | 2.91 pg/ml | ||||||
Precision | CV < 15% | Conc | Intra-assay | Inter-assay | Conc | Intra-assay | Inter-assay | ||
Low sample | 235 | 6.3% | 6.3% | 4 | 8.3% | 10.6% | |||
Medium sample | 299 | 2.6% | 4.5% | 6 | 14.3% | 14.3% | |||
High sample | 748 | 3.5% | 3.5% | 10 | 7.9% | 7.9% | |||
Mean | 4.1% | 4.8% | Mean | 10.2% | 10.9% | ||||
Dilutional linearity | 80–120% linearity | Mean 3 samples | Mean 3 samples | ||||||
DF (x) | %L | DF (x) | %L | ||||||
1 | - | 1 | - | ||||||
2 | 155 | 3 | 108 | ||||||
4 | 107 | 6 | 112 | ||||||
8 | 106 | 16 | 115 | ||||||
16 | 107 | 39 | 99 | ||||||
32 | 97 | 98 | 97 | ||||||
64 | 143 | ||||||||
Mean | 110% | Mean | 106% | ||||||
Parallelism | 80–120% in range with the slope of the calibrator | Mean 3 samples | Mean 5 samples | ||||||
Mean | SD | Mean | SD | ||||||
R2 | 0.94 | 0.0263 | 0.98 | 0.005 | |||||
Slope | 1.54 | 0.109 | 1.41 | 0.071 | |||||
Range | 103% | 7% | 89% | 4% |