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Table 5 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) ≤ 1.07% N/A
Inter-assay precision (%CV of endpoint log10 titer) 6.23% N/A
Sensitivity (based on affinity-purified polyclonal antibody) 0.080 μg/mL 32.7 μg/mL
Drug interference Not reassessed Not reassessed
Stability 24 h ambient
Freeze/thaw not reassessed
Not reassessed
  1. %CV coefficient of variation, ELISA enzyme-linked immunosorbent assay, InO inotuzumab ozogamicin, N/A not applicable, PC positive control