Table 4: FXI results for the international reference preparations.
Standard |
Attribute |
[1] |
[2] |
[3] |
[4] |
[5] |
[6] |
Mean |
RSD |
ISTH/ |
U/mL |
0.88 |
0.87 |
0.90 |
0.89 |
0.86 |
0.88 |
0.88 |
1.6 |
%label |
98.9 |
97.8 |
101.1 |
100.0 |
96.6 |
98.9 |
98.9 |
||
WHO |
IU/mL |
0.29 |
0.30 |
0.29 |
0.30 |
0.31 |
0.30 |
0.30 |
2.5 |
%label |
2.9 |
3.0 |
2.9 |
3.0 |
3.1 |
3.0 |
3.0 |
Remarks: The attribute "%label" expressed the FXI concentration found as a percent of the preparations' labeled potency, i.e., 0.89 U FXI/mL and 10 IU FXI/ml for the ISTH/SSC#4 and WHO 11/236 standard, respectively. While the ISTH/SSC#4 preparation was measured in six independent tests carried out by three operators, the WHO 11/236 standard was measured in six independent dilution series run on one plate.