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Table 3 Highlights of neutralizing antibody assay validation characteristics

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

PC Rabbit Anti-InO
Intra-assay precision (%CV of endpoint log10 titer) 6.1%
Inter-assay precision
Inter-assay precision (%CV of endpoint log10 titer) 9.3%
Sensitivity (based on affinity-purified polyclonal antibody) 58.3 ng/mL (in well concentration)
Drug interference PC antibody was detected in the presence of ≤1.0 μg/mL
Matrix selectivity (recovery) with PCs All unspiked samples generated signal below the cut point showing negative result; 100% of the ALL lots had recovery of neutralizing antibodies between 70% and 130%
Stability (PC) 21-h ambient temperature
5 freeze/thaw cycles at −70 °C
5 freeze/thaw cycles at −20 °C
Stability (cell passage numbers) ≤ 22 passages
  1. %CV coefficient of variation, ALL acute lymphoblastic leukemia, InO inotuzumab ozogamicin, PC positive control