Table 4.
Accuracy assessment against assigned ELISA concentration for GenWay, Demeditec, and ECL assays
| Internal sera sample panel for wP testing | ELISA reference assignment (EU/mL) | GenWay | Demeditec | ECL | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| GMC (NTU) |
% difference vs. | GMC (U/mL) |
% difference vs. | GMC (EU/mL) | % difference vs. | ||||||||
| Sample | Original Sample | PT | FHA | PT | FHA | PT | FHA | PT | FHA | PT | FHA | ||
| 1 | WWO-2–043 (100%) | 151.92 | 112.26 | 24.5 | − 84% | − 78% | 139.3 | − 8% | 24% | 130.8 | 93.8 | − 14% | − 16% |
| 2 | WWO-2–043 (75%) | 113.94 | 84.2 | 21.4 | − 81% | − 75% | 85.8 | − 25% | 2% | 98.1 | 70.3 | − 14% | − 17% |
| 3 | WWO-2–043 (50%) | 75.96 | 56.13 | 16.9 | − 78% | − 70% | 57.4 | − 24% | 2% | 73.5 | 51.1 | − 3% | − 9% |
| 4 | WWO-2–043 (20%) | 30.38 | 22.45 | 9.0a | − 70% | − 60% | 19.6a | − 35% | − 13% | 25.9 | 19.2 | − 15% | − 14% |
| 5 | WWO-2–043 (1%) | 1.52 | 1.12 | 0.6a | − 61% | − 47% | 1.8a | 19% | 62% | 1.3 | 1.1 | − 17% | − 2% |
| 6 | NIBSC 06/140 (100%) | 335 | 130 | 31.4 | − 91% | − 76% | 148.5 | − 56% | 14% | 426.0 | 155.7 | 27% | 20% |
| 7 | NIBSC 06/140 (75%) | 251.25 ara> | 97.5 | 27.6 | − 89% | − 72% | 113.5 | − 55% | 16% | 298.7 | 110.9 | 19% | 14% |
| 8 | NIBSC 06/140 (50%) | 167.5 | 65 | 23.2 | − 86% | − 64% | 80.9 | − 52% | 24% | 180.9 | 71.2 | 8% | 10% |
| 9 | NIBSC 06/140 (20%) | 67 | 26 | 14.2 | − 79% | − 45% | 25.2 | − 62% | − 3% | 69.6 | 27.5 | 4% | 6% |
| 10 | NIBSC 06/140 (1%) | 3.35 | 1.3 | 1.1 | − 66% | − 13% | 2.3 | − 32% | 75% | 3.7 | 1.7 | 11% | 29% |
| Overall | – | – | – | − 80% | − 64% | – | − 37% | − 15% | – | – | 0% | 1% | |
ECL electrochemoluminescence, ELISA enzyme-linked immunosorbent assay, FHA filamentous hemagglutiin, GMC geometric mean concentration, PT pertussis toxin, wP whole-cell pertussis
aBelow the cutoff value for the respective kits (< 11 NTU for GenWay and < 20 U/mL for Demeditec)