Table 3 Summary of the results found

Adalimumab

Accuracy

Samples spiked with ABP501 in 3 matrices

2 runs including the 2 batches. 1 test per level for each matrix

80% < N < 120%

Batch 1

90–120%

Table 1

Imprecision

Intra-run

Batch 2

93–105%

1 run for each batch. 10 tests per level for each matrix

CV < 20%

Batch 1

4.1–11.1%

Table 2a

Batch 2

3.8–16.5%

Inter-run

6 runs including the 2 batches. 2 tests per level for each matrix

Batch 1

4.4–13.9%

Table 2b

Batch 2

4.5–13.0%

Humira/AB501 levels in clinical samples

Humira clinical samples spiked with ABP501

30 samples

In a range of ± 20%

Within the range

Additional file 1: Table S1a

ABP501 clinical samples spiked with Humira

34 samples

Additional file 1: Table S1b

Correlation

3 runs × 30 samples spiked with:

Run 1: ABP501 batch 1

Run 2: ABP501 batch 2

Run 3: Humira

R² > 0.90

0.9 < Slope < 1.1

Batch1 versus Humira

R² = 0.95

Slope = 0.94

Figure 1a

Batch2 versus Humira

R² = 0.98

Slope = 0.94

Batch1 versus Batch2

R² = 0.94

Slope = 0.95

Anti-Adalimumab

Inhibition

Samples spiked with ABP501 or ABP501 + Humira. then with Anti-Ada antibodies

31 samples

% of inhibition > 50%

 > 77%

Additional file 1: Table S2a

ABP501 clinical samples spiked with Anti-Ada antibodies

34 samples

 > 92%

Additional file 1: Table S2b

Clinical samples with Anti-Ada antibodies spiked with Adalimumab (ABP501 or Humira)

31 samples

 > 62%

Additional file 1: Table S3

Detection step

Clinical samples diluted with Anti-Ada antibodies spiked with ABP501

38 samples

51–89% Except two with Anti-ADA levels near the LLOQ

Additional file 1: Table S4

Correlation

3 runs × 20 samples with Anti-Ada antibodies spiked with: Run 1: ABP501 batch 1

Run 2: ABP501 batch 2

Run 3: Humira

R² > 0.90

0.9 < Slope < 1.1

Batch1 versus Humira

R² = 0.98

Slope = 1.05

Figure 1b

Batch2 versus Humira

R² = 0.93

Slope = 1.04

Batch1 versus Batch2

R² = 0.97

Slope = 0.97

Kit’s stability

Samples spiked with ABP501 in different storage conditions for each run

2 kits. 1 run for each including the 2 bacthes. 2 tests per level

In a range of ± 20%

Within the range

Additional file 1: Table S5

Specimen’s stability

4 runs including the 2 batches. 2 tests per level for each storage condition