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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

N/A

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
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