Table 6: Results of the parallelism investigation for the three IgG products.
Attribute |
GG-SD |
GGL |
CUV |
|||
Neat |
Spiked |
Neat |
Spiked |
Neat |
Spiked |
|
IgG concentration |
50 |
100 |
200 |
|||
Starting dilution |
40 |
100 |
100 |
|||
Slope |
-0.9303 |
-0.9606 |
-1.0232 |
-1.0142 |
-0.9920 |
-0.9729 |
Correlation coefficient r |
0.9999 |
0.9999 |
0.9997 |
0.9999 |
0.9994 |
1.0000 |
%slope |
96.5 |
99.6 |
106.1 |
105.2 |
102.9 |
100.9 |
Remarks: IgG samples were spiked with 4.6 mU FXI/mL into the starting dilutions indicated. The row "Starting dilution" gives the starting dilution of the serial 1+1 dilution series, while the rows "Slope" and "Correlation coefficient" show slopes and correlation coefficients of the respective log-log dilution-response curves. Finally, the row "%slope" gives the slope of the samples' dilution-response curves as a percent of those obtained for the corresponding assay calibration curves.