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Table 6 Anti-rituximab antibody assay validation characteristics

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

Positive Control Goat Antihuman IgG Antibody
Intra-assay precision(%CV of endpoint log10 titer) 0.5%
Inter-assay precision (%CV of endpoint log10 titer) 1.8%
Sensitivity (based on affinity-purified polyclonal antibody) 0.29 ng/mL
Drug interference ≤ 0.1 μg/mL rituximab
≤10 μg/mL InO
Stability 4 h ambient
5 freeze/thaw cycles at − 70 °C
  1. %CV coefficient of variation, IgG immunoglobulin G, InO inotuzumab ozogamicin