Table 3.
Technical validation data of the DCN-CS ELISA assay
| Tecnical validation step | DCN-CS performance |
|---|---|
| Detection range (LLOD-ULOD) | 1.2–345.3 ng/mL |
| Lower limit of quantification (LLOQ) | 5.3 ng/mL |
| Intra-assay variation | 3% |
| Inter-assay variation | 13% |
| Dilution of serum samples | 1:4 |
| Dilution recovery (1:4 pre-dilution)a | 100% (82–113%) |
| Freeze/thaw recovery (4 cycles)a | 94% (90–97%) |
| Analyte stability up to 24 h, 4 °Ca | 87% (86–90%) |
| Interference Lipids, low/high | 107%/86% |
| Interference Biotin, low/high | 100%/100% |
| Interference Hemoglobin, low/high | 100%/100% |
aPercentages are reported as mean with range shown in brackets