Summary of results obtained during affinity ELISA validation
| Assay validation criteria . | Sample A* . | Sample B† . | Sample C‡ . | |
|---|---|---|---|---|
| Population 1 (high affinity) . | Population 2 (low affinity) . | |||
| Total IgG | ||||
| Intraassay stability | 10 | 5 | 15 | 9 |
| Interassay stability | 18 | 11 | 17 | 5 |
| Robustness (freeze/thaw) | 20 | 4 | 8 | 8 |
| IgG1 | ||||
| Intraassay stability | 5 | 2 | 5 | 11 |
| Assay validation criteria . | Sample A* . | Sample B† . | Sample C‡ . | |
|---|---|---|---|---|
| Population 1 (high affinity) . | Population 2 (low affinity) . | |||
| Total IgG | ||||
| Intraassay stability | 10 | 5 | 15 | 9 |
| Interassay stability | 18 | 11 | 17 | 5 |
| Robustness (freeze/thaw) | 20 | 4 | 8 | 8 |
| IgG1 | ||||
| Intraassay stability | 5 | 2 | 5 | 11 |
Data are CVs in percent.
Sample A: monoclonal human FVIII-specific IgG1 antibody spiked into human plasma not containing any FVIII-binding antibodies.
Sample B: human plasma from a healthy individual with FVIII-specific IgG1 diluted with human plasma not containing FVIII-binding antibodies.
Sample C: a mixture of samples A and B.