Evaluation of Multiple Immunoassay Technology Platforms to Select the Anti-Drug Antibody Assay Exhibiting the Most Appropriate Drug and Target Tolerance

Table 3

Interassay precision obtained on the different methods for nine levels of PCs (five levels of PCs were assessed on the Gyrolab platform with acid dissociation due to the lower number of structures present on the Gyrolab Mixing CDs). The precision is presented in %CV and is calculated from three independent runs performed on different days (except for the Gyrolab assay with acid dissociation where five independent runs were performed). Each run contained two sets of independently prepared PCs.

	Interassay precision (CV%)
Technology used	ELISA		MSD		Gyrolab		AlphaLISA
Acid dissociation step	No	Yes	No	Yes	No	Yes	No	Yes
Reference ADA concentration (PC) in ng/mL
2	<BLQ	<BLQ	5.51	<BLQ	8.39	NT	<BLQ	<BLQ
5	14.83	<BLQ	6.00	<BLQ	6.03	16.07	<BLQ	<BLQ
20	20.14	<BLQ	4.99	4.03	1.67	3.88	14.49	17.11
50	21.94	<BLQ	5.45	8.96	3.11	NT	9.46	14.43
100	24.67	18.89	3.09	11.57	2.58	5.04	10.34	13.83
250	23.81	5.66	4.62	21.46	4.97	NT	12.91	14.67
500	26.77	7.30	5.31	22.47	3.61	6.07	16.23	9.37
1000	23.56	2.50	4.73	25.98	2.89	NT	11.44	18.99
10000	13.41	1.73	6.37	25.95	6.87	7.21	4.19	4.76

“NT” was used for the PCs not tested due to the limited number of structures on Gyrolab Mixing CDs. “<BLQ” refers to a result below the sensitivity of the method.