Adalimumab and anti-adalimumab LISA-TRACKER immunoassays performance criteria for therapeutic drug monitoring of adalimumab-amgen biosimilar (ABP501)

Table 2 Determination of the imprecision for ABP501 quantification

	ADALIMUMAB from ABP501-Batch1 (µg/ml)									ADALIMUMAB from ABP501-Batch2 (µg/ml)
	Matrix 1 (M1)			Matrix 2 (M2)			Matrix 3 (M3)			Matrix 1 (M1)			Matrix 2 (M2)			Matrix 3 (M3)
	Low	Medium	High	Low	Medium	High	Low	Medium	High	Low	Medium	High	Low	Medium	High	Low	Medium	High
(a) Intra-run: 1 run for each batch, 10 tests per level for each matrix
Mean (µg/ml)	1.5	5.0	13.6	1.6	4.5	15.9	1.4	4.3	15.1	1.2	3.9	14.6	0.6	5.0	13.6	1.0	3.6	13.3
CV (%)	4.9	7.6	6.8	6.9	5.4	4.1	6.0	6.4	11.1	14.4	3.8	7.8	16.5	12.8	4.4	4.5	4.5	5.3
(b) Inter-run: 6 runs including the 2 batches, 2 tests per level for each matrix
Mean (µg/ml)	1.3	4.2	12.4	1.1	4.0	13.1	1.1	3.8	11.6	1.1	4.1	12.3	1.07	4.2	11.6	1.0	4.0	11.6
CV (%)	9.7	5.2	4.4	12.2	8.9	9.2	11.2	13.9	4.9	9.6	9.3	6.6	9.1	13.0	4.5	8.0	8.9	6.7

Imprecision was assessed by using clinical 3 levels (low, medium, high) for 3 human matrix and for each level. Tests were performed with LISA-TRACKER adalimumab assay for the ABP501 batch#1 and batch#2. The coefficients of determination were determined. All the quantifications were established by LISA-TRACKER adalimumab assay
(a) For Intra-run, 1 run for each batch, 10 tests per level for each matrix were performed
(b) For Inter-run, 6 runs including the 2 batches, 2 tests per level for each matrix were performed
Acceptance criteria: CV < 20%

ISSN: 1471-2172