1024 Monoclonal antibody
Parameters VS LLOQ 150.0 ng/mL VS Low 450.0 ng/mL VS Medium 1500.0 ng/mL VS High 8500.0 ng/mL VS ULOQ 10000.0 ng/mL
Mean Conc. (ng/mL) 156.2 468.6 1647.4 8542.1 11095.2
Accuracy (%BIAS) 4.1 4.2 9.8 0.5 10.9
SD 13.6 42.4 131.3 270.3 504.6
Precision (%CV) 8.7 9.0 8.0 3.2 4.5
n 11 11 10* 11 11
992 Monoclonal antibody
Parameters VS LLOQ 150.0 ng/mL VS Low 450.0 ng/mL VS Medium 1500.0 ng/mL VS High 8500.0 ng/mL VS ULOQ 10000.0 ng/mL
Mean Conc. (ng/mL) 152.8 465.9 1644.3 8818.4 10428.8
Accuracy (%BIAS) 0.6 3.5 9.6 3.7 4.3
SD 13.2 40.5 160.4 419.1 1158.5
Precision (%CV) 8.8 8.7 9.8 4.8 11.1
n 11 11 10* 11 11
Total
Parameters VS LLOQ 300.0 ng/mL VS Low 900.0 ng/mL VS Medium 3000.0 ng/mL VS High 17000.0 ng/mL VS ULOQ 20000.0 ng/mL
Mean Conc. (ng/mL) 286.5 999.1 3205.2 16572.3 21792.0
Accuracy (%BIAS) -4.5 11.0 6.8 -2.5 9.0
SD 18.9 104.5 360.3 1475.0 2687.7
Precision (%CV) 6.6 10.85 11.2 8.9 12.3
n 11 11 10* 11 11
*One outlier of a set of five values, excluded from the statistic calculation
Table 11: Inter-assay accuracy and precision of the LC-MS/MS analysis of 1024 mAb, 992 mAb and total mAbs in monkey serum.