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

AAPS Open

Table 5 Anti−InO antibody ELISA validation characteristics

PC	PC1: Rabbit Anti-G544 Polyclonal Antibody PC2: Rabbit Anti-Calicheamicin Polyclonal Antibody
PC	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

%CV coefficient of variation, ELISA enzyme-linked immunosorbent assay, InO inotuzumab ozogamicin, N/A not applicable, PC positive control