Table 4.
Parameter | IC1 | IC2 | IC3 | IC4 | IC5 |
---|---|---|---|---|---|
Nominal titer (EU/ml) | 635 | 282 | 125 | 55.8 | 24.8 |
Acceptance titer range (EU/ml) | 476–794 | 226–339 | 100–151 | 44.6–66.9 | 18.6–31.0 |
No. of samples (Crucell + ABL) | 29 | 29 | 30 | 30 | 48 |
Mean titer (EU/ml) | 662.9 | 278.4 | 127.6 | 56.1 | 25.5 |
Reproducibility | |||||
SD | 86.4 | 39.8 | 13.7 | 8.1 | 2.9 |
% CV | 13.0 | 14.3 | 10.8 | 14.4 | 11.5 |
IC1 to IC5, internal control samples 1 to 5, respectively.