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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
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