Table 1.

Summary of inter-assay precision from different ADA assay formats.

	Direct assay with protein A/G		Direct assay with species-specific antibodies		Bridging assay for preclinical studies		Bridging assay for clinical studies		ACE assay
PCs and NC	Conc. (ng/mL)	%CV	Conc. (ng/mL)	%CV	Conc. (ng/mL)	%CV	Conc. (ng/mL)	%CV	Conc. (ng/mL)	%CV
NC	0	15.8	0	4.9	0	5.2	0	3.6	0	9.2
HPC	1600	14.2	5000	9.9	10000	9.5	10000	8.8	10000	19.2
LPC	3	12.4	50	13.2	250	13.3	100	10.3	100	16.1

The inter-assay precision (%CV) of NCs and PCs was calculated from at least four method development runs which were performed on different days. Conc.= Concentration; CV = coefficient of variation; NC = Negative control; PC = Positive control; HPC = high positive control; LPC = Low positive control.