Table 3.
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 | 2505 | 10.45 | 3.92 | 10933 | 8.88 | 7.62 | 2150 | 11.53 | 4.15 | 38897 | 4.53 | 6.58 | 466 | 15.14 | 14.43 |
| AFP | 500-600000 | pg/mL | 11980 | 13.92 | 5.32 | 54865 | 12.72 | 5.09 | 10703 | 12.14 | 3.43 | 455084 | 8.59 | 20.68 | 1598 | 34 | 66.04 |
| Total PSA | 50-60000 | pg/mL | 1230 | 15.82 | 5.11 | 5880 | 11.51 | 11.21 | 1057 | 8.61 | 0.32 | 7762 | 7.88 | 4.59 | < MR | < MR | < MR |
| CA 15-3 | 0.5-600 | U/mL | 12 | 18.57 | 6.38 | 57 | 21.29 | 2.85 | 11 | 20.52 | 1.79 | 29 | 16.48 | 8.48 | 24 | 27.78 | 21.2 |
| CA 19-9 | 2-3000 | U/mL | 61 | 20.3 | 4.79 | 292 | 12.19 | 4.58 | 54 | 11.44 | 2.19 | 33 | 17.49 | 7.29 | 10 | 19.24 | 23.19 |
| CA 125 | 2-4000 | U/mL | 71 | 13.39 | 3.23 | 347 | 11.19 | 3.9 | 68 | 11.73 | 1.91 | 302 | 6.26 | 8.27 | 5.53 | 22.25 | 36.3 |
| β-HCG | 0.2-400 | mU/mL | 8 | 17.8 | 4.39 | 39 | 16.3 | 1.48 | 7 | 15.48 | 2.41 | 0.65 | 4.49 | 61.53 | < MR | < MR | < MR |
| CYFRA 21-1 | 500-900000 | pg/mL | 29454 | 16.78 | 27.37 | 155151 | 15.64 | 40.96 | 16614 | 42.71 | 1.14 | 9724 | 38.02 | 50 | 3506 | 21.25 | 30.8 |
| HE4 | 2000-3000000 | pg/mL | 55648 | 27.52 | 5.48 | 291745 | 23.45 | 3.46 | 55123 | 23.76 | 2.74 | 2276 | 14.67 | 63.85 | < MR | < MR | < MR |
| Prolactin | 500-600000 | pg/mL | 11868 | 26.35 | 4.16 | 60195 | 15.98 | 2.69 | 10922 | 14.69 | 1.97 | 12057 | 21.22 | 10.08 | 10765 | 35.99 | 20.91 |
| Leptin | 500-600000 | pg/mL | 13056 | 23.59 | 2.44 | 62955 | 14.97 | 3.92 | 10971 | 15.63 | 1.81 | 13430 | 18.98 | 8.79 | 8468 | 36.1 | 23.77 |
| OPN | 2000-3000000 | pg/mL | 53895 | 45.75 | 4.01 | 236975 | 29.04 | 4.62 | 43171 | 31.41 | 2.38 | 73954 | 46.72 | 8.5 | 10870 | 85.54 | 22.7 |
| HGF | 100-120000 | pg/mL | 2452 | 13.41 | 12.19 | 12766 | 16.96 | 8.28 | 2154 | 20.58 | 1.7 | 785 | 7.96 | 11.57 | 283 | 10.19 | 20.14 |
| MIF | 100-120000 | pg/mL | 2230 | 19.69 | 7.89 | 11061 | 14.32 | 4.89 | 2209 | 12.31 | 1.68 | 574 | 8.59 | 13.68 | 513 | 63.56 | 62.9 |
| sFas | 100-150000 | pg/mL | 2486 | 27.52 | 6.36 | 12705 | 21.86 | 6.83 | 2779 | 26.23 | 1.37 | 3548 | 30.07 | 7.78 | 2217 | 51.45 | 22.99 |
| sFasL | 50-60000 | pg/mL | 1219 | 16.69 | 4.68 | 5898 | 20.4 | 2.92 | 1091 | 17.72 | 1.62 | < MR | < MR | < MR | < MR | < MR | < MR |
| TRAIL | 10-12000 | pg/mL | 252 | 13.53 | 4.72 | 1233 | 13.51 | 4.09 | 221 | 15.17 | 1.85 | 65 | 10.05 | 9.26 | 92 | 27.2 | 23.98 |
| VEGF | 50-60000 | pg/mL | 1127 | 25.4 | 4.27 | 6110 | 24.51 | 8.87 | 1115 | 18.99 | 3.76 | < MR | < MR | < MR | < MR | < MR | < MR |
| IL-6 | 2-3000 | pg/mL | 49 | 14.49 | 9.34 | 226 | 22.21 | 17.12 | 53 | 18.81 | 4 | 16 | 12.3 | 14.64 | < MR | < MR | < MR |
| IL-8 | 5-6000 | pg/mL | 122 | 8.85 | 5.21 | 605 | 11.32 | 3.73 | 110 | 9.31 | 1.98 | 33 | 9.31 | 8.37 | 6.71 | 25.35 | 40.54 |
| TNFα | 5-6000 | pg/mL | 114 | 21.44 | 5.52 | 562 | 16.31 | 6.81 | 110 | 16.78 | 2.28 | 13 | 19.54 | 8.14 | 6.41 | 26.96 | 40.75 |
| TGFα | 10-12000 | pg/mL | 237 | 16.15 | 6.26 | 1180 | 13.07 | 3.33 | 221 | 15.5 | 1.97 | 24 | 16.87 | 23.88 | 18 | 24.27 | 32.78 |
| FGF2 | 50-50000 | pg/mL | 1101 | 11.17 | 8.98 | 5571 | 13.86 | 5.71 | 1066 | 12.75 | 3.89 | 55 | 11.36 | 68.81 | 79 | 19.8 | 40.04 |
| SCF | 20-30000 | pg/mL | 599 | 15.96 | 10.08 | 2813 | 13.38 | 4.75 | 550 | 14.69 | 1.93 | 58 | 11.5 | 10.22 | 50 | 24.27 | 22.5 |
Inter-assay imprecision results for all 24 tested markers based on FI as well as observed concentration (Obs Conc) results of assays 1-5 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.