Table 2 Highlights of ECL antibody assay validation characteristics
PC | PC1: Rabbit Anti-InO PC2: Rabbit Anti-CMC (Payload) Antibody |
|---|---|
PCs in biological matrix (drug tolerance and confirmation assay) | HPC 1:75 in 100% serum |
LPC 1:750 in 100% serum | |
Intra-assay precision (%CV of endpoint log10 titer) | 0.8% |
Inter-assay precision (%CV of endpoint log10 titer) | 1.2% |
Sensitivity (affinity-purified polyclonal antibody) | 215Â ng/mL (in 100% serum) |
Drug interference | PC at high concentration was detected in the presence of 50 μg/mL; PC at low concentration was detected in the presence of 5.0 μg/mL |
Matrix selectivity (recovery) with PCs | All unspiked samples generated signal below the cut point showing negative result; 90% of ALL lots tested had recovery between 75% and 125% for both control antibodies |
Stability (PC1 and PC2) | 23-h ambient temperature |
5 freeze/thaw cycles at − 70 °C and − 20 °C | |
Stability (biotinylated and ruthenylated InO freeze/thaw stability) | 5 freeze/thaw cycles at − 70 °C |