Table 4.
Summary statistics of urine samples analyzed with renal biomarkers under characterization within the current study
| Parameter | Concentration
|
Concentration normalized to creatinine
|
||
|---|---|---|---|---|
| Confidence interval | %CVinter%CVintra | Confidence interval | %CVinter/%CVintra | |
| Single analyte assays (central laboratory) | ||||
| Creatinine | 1.09–12.46 mmol/L | 73/38 | NC | NC |
| NAG | 0.05–2.24 U/L | 117/62 | NC | NC |
| Single analyte assays (Pacific Biomarkers) | ||||
| B2M | 20–83 μg/L | 50/29 | 0.04–0.15 μg/mg | 43/29 |
| Creatinine | 0.06–1.29 mg/mL | 74/44 | NC | NC |
| Cystatin C | 0.003–0.042 mg/L | 68/40 | 21.3–77.2 ng/mg | 33/10 |
| KIM-1 | 15–249 pg/mL | 65/43 | 50.3–539.7 pg/mg | 50/17 |
| NAG | 0.34–2.4 U/L | 62/37 | 0.001–0.003 U/mg | 32/17 |
| NGAL | 0.3–150.3 ng/mL | 299/50 | 1.9–580.3 ng/mg | 325/38 |
| Multiplex assays (Rules Based Medicine) | ||||
| A1M | 0.12–3.00 μg/mL | 109/43 | 0.45–4.58 μg/mg | 63/23 |
| B2M | 0.01–0.09 μg/mL | 51/43 | 0.03–0.18 μg/mg | 40/21 |
| Calbindin | 0.31–114.0 ng/mL | 158/82 | 1.6–133.3 ng/mg | 107/60 |
| Clusterin | 0.00–0.07 μg/mL | 74/54 | 0.01–0.15 μg/mg | 75/24 |
| CTGF | 0.20–1.00 ng/mL | 41/33 | 0.19–2.08 ng/mg | 58/32 |
| Creatinine | 9.9–144.0 mg/dL | 58/40 | NC | NC |
| Cystatin-C | 3.2–75.0 ng/mL | 65/50 | 17.5–70.4 ng/mg | 27/19 |
| GSTα | 1.1–64.0 ng/mL | 78/61 | 1.8–169.0 ng/mg | 94/56 |
| KIM-1 | 0.05–0.48 ng/mL | 49/39 | 0.11–0.90 ng/mg | 42/15 |
| Microalbumin | 0.4–62.0 μg/mL | 260/47 | 1.9–258.3 μg/mg | 331/33 |
| NGAL | 3–254 ng/mL | 233/48 | 6.4–271.2 ng/mg | 264/45 |
| Osteopontin | 66–1,230 ng/mL | 66/50 | 236–1,459 ng/mg | 36/18 |
| THP | 0.23–1.90 μg/mL | 38/40 | 0.75–4.17 μg/mg | 38/20 |
| TIMP-1 | 0.3–10.0 ng/mL | 108/72 | 0.34–13.09 ng/mg | 114/67 |
| TFF3 | 0.03–3.10 μg/mL | 205/43 | 0.09–9.06 μg/mg | 230/32 |
| VEGF | 105–879 pg/mL | 52/35 | 456–1,286 pg/mg | 24/15 |
Abbreviations: NC, not calculated; A1M, alpha-1-microglobulin; B2M, β-2-microglobulin; CTGF, connective tissue growth factor; GSTα, glutathione S-transferase alpha; KIM-1, kidney injury marker-1; NAG, N-acetyl-β-glucosaminidase; NGAL, neutrophil gelatinase-associated lipocalin; THP, Tamm-Horsfall urinary glycoprotein; TIMP-1, tissue inhibitor of metalloproteinase 1; TFF3, trefoil factor 3; VEGF, vascular endothelial growth factor; %CVinter, intersubject coefficient of variation; %CVintra, intrasubject coefficient of variation.