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) 164.6 505.8 1690.0 8706.2 11095.0
Accuracy (%BIAS) 9.7 12.4 12.7 2.4 10.9
SD 7.6 18.8 37.3 241.2 239.2
Precision (%CV) 4.6 3.7 2.2 2.8 2.2
n 5 5 4* 5 5
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) 143.5 482.3 1746.1 8596.7 9372.9
Accuracy (%BIAS) -4.3 7.2 16.4 1.1 -6.3
SD 16.7 20.7 94.8 425.9 771.4
Precision (%CV) 11.7 4.3 5.4 5.0 8.2
n 5 5 4* 5 5
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) 293.4 1021.9 3395.0 17488.8 23288.3
Accuracy (%BIAS) -2.2 13.5 13.2 2.9 16.4
SD 5.9 76.0 216.6 1256.3 1341.9
Precision (%CV) 2.0 7.4 6.4 7.2 5.8
n 5 5 4* 5 5
*One outlier of a set of five values, excluded from the statistic calculation
Table 10: Intra-assay accuracy and precision of the LC-MS/MS analysis of 1024 mAb, 992 mAb and total mAbs in monkey serum.