Table 1.
Technical validation of the C4G assay.
| Technical Validation Step | Results |
|---|---|
| LLMR (uncorrected for pre-dilution) | 2.3 ng/mL |
| ULMR (uncorrected for pre-dilution) | 788 ng/mL |
| Calc. midpoint (IC50) | 8.8 ng/mL |
| Intra-assay variation | 6% |
| Inter-assay variation | 8% |
| Dilution recovery of serum | 94% |
| Dilution recovery of EDTA plasma | 106% |
| Spiking recovery of serum in serum | 102% |
| Analyte recovery, 4 freeze/thaw cycles | 96% |
| Analyte recovery 24h, 4 °C/20 °C | 109%/106% |
| Analyte recovery 48h, 4 °C/20 °C | 122%/109% |
| Interference test | |
| Biotin recovery, low/high | 94%/71% |
| Lipemia recovery, low/high | 111%/102% |
| Hemoglobin recovery, low/high | 99%/92% |
LLMR: lower limit of measurement range; ULMR: upper limit of measurement range. Percentages are reported as mean.