Table 3.

Repeatability (intra-assay CV), intermediate precision (interassay CV), and accuracy results of precision experimentsa

ParameterQC1QC2QC3QC4QC5
Nominal titer (EU/ml)63528212555.824.8
Acceptance titer range (EU/ml)476–794226–339100–15144.6–66.918.6–31.0
No. of samples1717181836
Mean titer (EU/ml)691.2296.3133.359.026.3
Intra-assay SD80.222.810.62.61.2
Intra-assay % CV11.67.78.04.44.4
Interassay SD97.941.014.18.22.8
Interassay % CV14.213.810.513.810.8
Accuracy (%)108.9105.1106.6105.7106.0
Bias (%)8.95.16.65.76.0
Total error23.118.920.719.516.8
  • a Composed from Output SAS analysis.