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
(mg/mL)

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.