Table 1 Assay characteristics for each individual biomarker
Analyte | Amyloid β 1–40 | Amyloid β 1–42 | Total Tau | Neurogranin Trunc P75 | BACE-1 | α-synuclein | ||
|---|---|---|---|---|---|---|---|---|
Technology | Sandwich ELISA (colorimetric) | |||||||
Vendor | Euroimmun | Euroimmun | Euroimmun | Euroimmun | Euroimmun | Euroimmun | ||
Product code | EQ 6511–9601-L | EQ 6521–9601-L | EQ 6531–9601-L | EQ 6551– 9601-L | EQ 6541–9601-L | EQ 6545–9601-L | ||
Assay design | Capture mAb | ADx103 (2G3) | ADx102 (21F12) | ADx201 | ADx451 (ADxNGCT1) | ADx401 (5G7) | ADx301 | |
Detector mAb | ADx101 (3D6) | ADx101 (3D6) | ADx215 | ADx403 (ADxNGCI2) | ADx402 (10B8F1) | ADx302 | ||
Sample Incubation | Sample volume (μL) | 15 | 15 | 25 | 15 | 15 | 25 | |
Detector volume (μL) | 100 | 100 | 100 | 100 | 100 | 100 | ||
Incubation time (h) | 4 | 4 | 4 | 4 | 4 | 4 | ||
Incubation temperature (°C) | 18–25 | 18–25 | 18–25 | 18–25 | 18–25 | 18–25 | ||
Sample dilution factor (1:x) | 21 | No dilution | No dilution | No dilution | No dilution | No dilution | ||
Run validation data | %CV QC samples (n = 3; min-max) | 9.6–14.5 | 4.5–20.8 | 9.5–10.2 | 3.6–6.4 | 5.9–12.4 | 4.3–5.8 | |
%CV Kit controls (n = 2; min-max) | 6.0–9.3 | 2.6–5.0 | 3,3–7.7 | 4.1–4.3 | 4.1–8.1 | 3.8–3.9 | ||
Intra-assay CV (%) (n = 2; min-max) | 0.0–15.3 | 0.0–23.6 | 0.0–17.3 | 0.0–12.9 | 0.0–8.8 | 0.0–12.7 | ||
Calibrator | Calibrator range (pg/mL) | 54–986 | 81–1724 | 56–1552 | 53–1799 | 238–11,212 | 150–5988 | |
Sample concentration range (pg/mL) | p5 | 3785 | 188 | 251 | 154 | 1098 | 1226 | |
p25 | 5933 | 383 | 342 | 229 | 1647 | 1742 | ||
p50 | 8500 | 589 | 405 | 350 | 2091 | 2311 | ||
p75 | 10,529 | 882 | 529 | 472 | 2904 | 2952 | ||
p95 | 13,542 | 1272 | 812 | 745 | 3583 | 4190 | ||
Minimum | 2431 | 92 | 186 | 115 | 940 | 1085 | ||
Median | 8501 | 589 | 405 | 349.5 | 2091.5 | 2311.5 | ||
Maximum | 18,307 | 1592 | 922 | 1194 | 5172 | 5388 | ||