Reproducibility of affinity ELISA results for representative samples of FVIII inhibitor patients
| Total IgG assay validation criteria . | Sample D* . | Sample E* . | |
|---|---|---|---|
| Population 1 (high affinity) . | Population 2 (low affinity) . | ||
| Intraassay stability | 11 | 30 | 43 |
| Interassay stability | 25 | 41 | 41 |
| Robustness (freeze/thaw) | 8 | 51 | 37 |
| Total IgG assay validation criteria . | Sample D* . | Sample E* . | |
|---|---|---|---|
| Population 1 (high affinity) . | Population 2 (low affinity) . | ||
| Intraassay stability | 11 | 30 | 43 |
| Interassay stability | 25 | 41 | 41 |
| Robustness (freeze/thaw) | 8 | 51 | 37 |
Data are CVs in percent.
Samples D and E: human plasma from 2 subjects with severe congenital
hemophilia A and FVIII inhibitor, diluted with human plasma not containing
FVIII-binding antibodies.