Table 4.
Extended inter-assay imprecision
|
QC 1 |
QC 2 |
St 5 |
Pool 1 |
Pool 2 |
|||||||||||||
| Biomarker | Measuring | Unit | Conc | FI | Conc | Conc | FI | Conc | Conc | FI | Conc | Conc | FI | Conc | Conc | FI | Conc |
| range | Mean | Mean CV% | Mean CV% | Mean | Mean CV% | Mean CV% | Mean | Mean CV% | Mean CV% | Mean | Mean CV% | Mean CV% | Mean | Mean CV% | Mean CV% | ||
| CEA | 100-120000 | pg/mL | 2545 | 13.96 | 28.08 | 12727 | 20.57 | 25.67 | 2146 | 13.34 | 4.59 | 39391 | 6.94 | 7.38 | 560 | 14.32 | 25.77 |
| AFP | 500-600000 | pg/mL | 12038 | 23.54 | 20.99 | 56960 | 19.11 | 10.29 | 10754 | 21.43 | 3.25 | 493993 | 12.38 | 18.42 | 1489 | 33.13 | 63.64 |
| Total PSA | 50-60000 | pg/mL | 1421 | 34.29 | 31.87 | 6172 | 17.44 | 13.78 | 1052 | 18.72 | 3.67 | 8246 | 16.03 | 12.46 | 68 | 130.09 | 151.66 |
| CA 15-3 | 0.5-600 | U/mL | 12 | 30.11 | 18.58 | 62 | 29.25 | 12.98 | 11 | 34.01 | 2.93 | 33 | 23.72 | 17.26 | 26 | 30.49 | 27.59 |
| CA 19-9 | 2-3000 | U/mL | 64 | 22.71 | 17.91 | 329 | 11.98 | 19.1 | 54 | 19.2 | 2.71 | 36 | 15.18 | 26.88 | 10 | 16.18 | 36.06 |
| CA 125 | 2-4000 | U/mL | 74 | 14.42 | 22.04 | 370 | 12.5 | 11.07 | 68 | 17.29 | 2.42 | 317 | 7.72 | 12.62 | 6.13 | 18.13 | 37.03 |
| β-HCG | 0.2-400 | mU/mL | 7.85 | 20.62 | 20.74 | 42 | 16.95 | 16.23 | 7 | 26.88 | 2.69 | 1.2 | 29.09 | 52.2 | 0.55 | 17.3 | 74.36 |
| CYFRA 21-1 | 500-900000 | pg/mL | 24985 | 69.07 | 36.07 | 152731 | 81.41 | 52.97 | 16601 | 53.61 | 2.5 | 8627 | 50.45 | 55.77 | 3506 | 31.82 | 30.8 |
| HE4 | 2000-3000000 | pg/mL | 55766 | 22.11 | 21.46 | 295050 | 19.92 | 10.63 | 55043 | 22.45 | 2.1 | 2288 | 19.7 | 68.01 | 2590 | 22.73 | 54.77 |
| Prolactin | 500-600000 | pg/mL | 11952 | 23.76 | 21.49 | 60823 | 13.52 | 9.33 | 10863 | 14.81 | 2.05 | 12191 | 17.16 | 20.41 | 10602 | 29.43 | 28.46 |
| Leptin | 500-600000 | pg/mL | 13001 | 29.19 | 15.47 | 64533 | 19.61 | 8.82 | 11020 | 23.3 | 1.88 | 14622 | 16.75 | 18.61 | 9145 | 31.06 | 27.03 |
| OPN | 2000-3000000 | pg/mL | 57576 | 58.11 | 28.1 | 240688 | 24.08 | 13.88 | 42845 | 25.18 | 5.71 | 75488 | 41.77 | 25.01 | 10700 | 62.83 | 47.91 |
| HGF | 100-120000 | pg/mL | 2546 | 15.19 | 20.7 | 13471 | 19.05 | 12.85 | 2171 | 22.65 | 2.04 | 894 | 7.18 | 27.83 | 436 | 29.6 | 49.81 |
| MIF | 100-120000 | pg/mL | 2263 | 46.52 | 45.1 | 12332 | 20.48 | 18.05 | 2220 | 23.01 | 2.93 | 876 | 62.88 | 48.48 | 517 | 45.1 | 47.35 |
| sFas | 100-150000 | pg/mL | 2533 | 27.15 | 18.62 | 13212 | 20.06 | 12.63 | 2775 | 27.38 | 1.77 | 4005 | 29.39 | 21.39 | 2472 | 39.44 | 28.26 |
| sFasL | 50-60000 | pg/mL | 1245 | 19.09 | 20.91 | 6023 | 21.37 | 6.63 | 1093 | 22.37 | 1.98 | < MR | < MR | < MR | < MR | < MR | < MR |
| TRAIL | 10-12000 | pg/mL | 253 | 20.17 | 21.78 | 1269 | 17.13 | 10.13 | 220 | 21.55 | 2.05 | 72 | 11.04 | 32.6 | 98 | 26.7 | 35.57 |
| VEGF | 50-60000 | pg/mL | 1146 | 46.21 | 23 | 6155 | 45.49 | 8.97 | 1100 | 43.93 | 3.26 | < MR | < MR | < MR | < MR | < MR | < MR |
| IL-6 | 2-3000 | pg/mL | 54 | 17.46 | 26.94 | 268 | 17.39 | 23.92 | 54 | 24.51 | 5.54 | 21 | 14.19 | 41.05 | < MR | < MR | < MR |
| IL-8 | 5-6000 | pg/mL | 124 | 75.72 | 21.22 | 668 | 45.79 | 22.2 | 111 | 30.7 | 3.13 | 26 | 36.91 | 38.62 | 6.70 | 90.89 | 40.54 |
| TNFα | 5-6000 | pg/mL | 117 | 18.6 | 23.55 | 583 | 16.6 | 11.16 | 111 | 19.41 | 2.52 | 16 | 15.5 | 28.1 | 7.85 | 22.35 | 49.24 |
| TGFα | 10-12000 | pg/mL | 238 | 18.16 | 21.43 | 1210 | 19.49 | 7.74 | 221 | 22.29 | 2.56 | 27 | 17.64 | 45.12 | 18 | 19.22 | 48.85 |
| FGF2 | 50-50000 | pg/mL | 1104 | 25.12 | 23.52 | 5708 | 17.67 | 9.9 | 1068 | 19.05 | 3.55 | 68 | 9.43 | 49.91 | 80 | 15.21 | 32.41 |
| SCF | 20-30000 | pg/mL | 603 | 12.44 | 19.52 | 2951 | 16.66 | 11.26 | 549 | 17.88 | 2.01 | 79 | 31.9 | 40.75 | 59 | 22.35 | 32.17 |
Inter-assay imprecision results for all 24 tested markers based on FI as well as observed concentration (Obs Conc) results of all assays 1-10 for synthetic quality controls QC 1, QC 2, standard 5 as well as for physiological serum pools 1 and 2. AFP: Alpha-fetoprotein; CA 125: Cancer antigen 125; CEA: Carcinoembryonic antigen; CV: Coefficient of variation; CYFRA 21-1: Cytokeratine 19-fragment; FGF2: Fibroblast growth factor-2; FI: Fluorescent intensity; HE4: Human epididymis protein 4; HGF: Hepatocyte growth factor; IL-6: Interleukin-6; MIF: Macrophage migration inhibitory factor; MR: Measuring range; Conc: Concentration; OPN: Osteopontin; QC 1: Quality control 1; SCF: Stem cell factor; sFas: Soluble Fas; sFasL: Soluble Fas-ligand; TGFα: Transforming growth factor-α; TNFα: Tumor necrosis factor-α; total PSA: Total prostate-specific antigen; TRAIL: Tumor necrosis factor related apoptosis-inducing ligand; VEGF: Vascular endothelial growth factor; β-HCG: β-human chorionic gonadotropin.