Table 3: Spike-recovery data for the IgG products GAMMAGARD S-D, GAMMAGARD LIQUID and CUVITRU.
Sample |
Recovery of spiked FXI (%) |
||||||
Run 1 |
Run 2 |
Run 3 |
Run 4 |
Run 5 |
Run 6 |
Mean |
|
GG-SD |
98.1 |
100.8 |
93.4 |
99.3 |
102.0 |
102.9 |
99.4 |
GGL |
100.4 |
94.9 |
97.6 |
98.6 |
99.6 |
103.3 |
99.1 |
CUV |
106.9 |
109.4 |
105.6 |
106.1 |
105.8 |
106.7 |
106.8 |
Remarks: Recovery was calculated using the formula (found FXI concentration/expected FXI concentration × 100).