A bridging assay for detection and characterization of anti-drug antibodies to dostarlimab, a new anti-PD-1 therapeutic monoclonal antibody

AAPS Open

Table 6 Summary of control ECL range setting

	Mean ECL	SD	(t0.005 × SD)	Mean + (t0.005 × SD)	Mean – (t0.005 × SD)
NC	111	10.8	32	143	NA
LPC^a	333	36.0	107	440	227
MPC	2802	315.4	937	3739	1865
HPC	145765	14846	44113	189878	101652

^aLPC concentration is 40 ng/mL. The 99.5% upper limit of NC was calculated as mean + t(0.005, n−1) × SD, where t(0.005, df) corresponds to a 0.5% error rate and n represents the number of independent replicate NC results used in this evaluation. The 99% range limits for pAb LPC (40 ng/mL), MPC and HPC ECL values were calculated as mean ± t(0.005, n−1) × SD, where t(0.005,df) and n are defined as above and correspond to a 1% failure rate