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Table 4 Anti-InO antibody ELISA validation characteristics

From: Assessment of clinical immunogenicity of inotuzumab ozogamicin in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia

PC PC1: Rabbit Anti-G544 Polyclonal Antibody
PC2: Rabbit Anti-Calicheamicin Polyclonal Antibody
  PC1 PC2
Intra-assay precision (%CV of endpoint log10 titer) ≤ 1.8% N/A
Inter-assay precision (%CV of endpoint log10 titer) 1.8% N/A
Sensitivity (based on affinity-purified polyclonal antibody) 224 ng/mL
Drug interference ≤ 0.01 μg/mL InO
≤ 1000 μg/mL rituximab
≤ 0.1 μg/mL InO
Stability (PC1 and PC2) 3 h at room temperature
3 freeze/thaw cycles at − 70 °C
  1. %CV coefficient of variation, ELISA enzyme-linked immunosorbent assay, InO inotuzumab ozogamicin, N/A not applicable, PC positive control