Table 5.
Accuracy assessment using relative assignment from the same assay for GenWay, Demeditec, and ECL assays
| Internal sera sample panel for wP testing | Genway | Demeditec | ECL (PT) | ECL (FHA) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | Original sample | Observed | Expected | Percent Recovery | Observed | Expected | Percent Recovery | Observed | Expected | Percent Recovery | Observed | Expected | Percent Recovery |
| 1 | WWO-2-043 (100%) | 24.5 | N/A | N/A | 139.3 | N/A | N/A | 130.8 | N/A | N/A | 93.8 | N/A | N/A |
| 2 | WWO-2-043 (75%) | 21.4 | 18.4 | 116% | 85.8 | 104.5 | 82% | 98.1 | 98.1 | 100% | 70.3 | 70.4 | 100% |
| 3 | WWO-2-043 (50%) | 16.9 | 12.2 | 138% | 57.4 | 69.6 | 82% | 73.5 | 65.4 | 112% | 51.1 | 46.9 | 109% |
| 4 | WWO-2-043 (20%) | 9.0 | 4.9 | 185% | 19.6 | 27.9 | 70% | 25.9 | 26.2 | 99% | 19.2 | 18.8 | 103% |
| 5 | WWO-2-043 (1%) | 0.6 | 0.2 | 243% | 1.8 | 1.4 | 130% | 1.3 | 1.3 | 96% | 1.1 | 0.9 | 117% |
| 6 | NIBSC 06/140 (100%) | 31.4 | N/A | N/A | 148.5 | N/A | N/A | 426.0 | N/A | N/A | 155.7 | N/A | N/A |
| 7 | NIBSC 06/140 (75%) | 27.6 | 23.6 | 117% | 113.5 | 111.4 | 102% | 298.7 | 319.5 | 93% | 110.9 | 116.7 | 95% |
| 8 | NIBSC 06/140 (50%) | 23.2 | 15.7 | 148% | 80.9 | 74.2 | 109% | 180.9 | 213.0 | 85% | 71.2 | 77.8 | 92% |
| 9 | NIBSC 06/140 (20%) | 14.2 | 6.3 | 226% | 25.2 | 29.7 | 85% | 69.6 | 85.2 | 82% | 27.5 | 31.1 | 88% |
| 10 | NIBSC 06/140 (1%) | 1.1 | 0.3 | 361% | 2.3 | 1.5 | 153% | 3.7 | 4.3 | 88% | 1.7 | 1.6 | 108% |
ECL electrochemoluminescence, FHA filamentous hemagglutiin, N/A not applicable, PT pertussis toxin, wP whole-cell pertussis