Table 3.
Assay performance of the CytoBead CeliAK assay
| Day | TG2autoAb (U/mL) | DG Ab (U/mL) | Total IgA (g/L) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | |
| Intra-assay variance | |||||||||||||||
| 68.6 | 69.5 | 67.6 | 70.2 | 69.0 | 49.2 | 35.6 | 41.7 | 44.0 | 41.6 | 0.32 | 0.29 | 0.28 | 0.29 | 0.27 | |
| SD | 4.3 | 1.8 | 2.6 | 3.2 | 1.1 | 3.4 | 3.4 | 2.6 | 1.8 | 2.9 | 0.02 | 0.02 | 0.02 | 0.02 | 0.02 |
| CV % | 6.3 | 2.6 | 3.8 | 4.5 | 1.5 | 6.9 | 9.5 | 6.2 | 4.0 | 6.9 | 6.2 | 6.9 | 7.1 | 6.8 | 7.4 |
| Inter-assay variance days a–e | |||||||||||||||
| 68.9 | 42.4 | 0.29 | |||||||||||||
| SD | 0.9 | 4.9 | 0.01 | ||||||||||||
| CV % | 1.4 | 11.5 | 6.4 | ||||||||||||
Autoantibodies (autoAb) to tissue transglutaminase type 2 (TG2) and deamidated gliadin (DG) as well total serum IgA were determined by CytoBead CeliAK in reference sera diluted 1–10. Intra-assay and inter-assay (8 times per run over 5 days) coefficients of variation (CV) were determined in accordance with the CLSI protocol EP15-A2
AU arbitrary units, SD standard deviation