60 Chapter 3 Table 3. Accuracy and precision validation data for QC’s at LLOQ, Low, Medium and High levels. Withinrun data were based on 5 replicates and between-run data on 3 different days. Precision (% CV) Accuracy (% bias) QC Within- run Between-run Overall Overall LLOQ 14.5 13.5 19.8 3.3 Low 7.4 5.3 9.1 -4.3 Med 3.2 5.7 6.5 -4.5 High 2.2 4.6 5.1 -4.7 Table 4. QC data of within-run and between run accuracy and precision for the calculation of the combined standard uncertainty through the Nordtest approach. Nominal value [ng/mL] Day #1 #2 #3 #4 #5 CV [%] Bias [%] LLOQ 1 0.995 0.680 1.075 1.097 0.900 1 2 1.351 1.148 1.106 1.179 1.275 18.46 3.33 3 1.187 0.839 1.045 0.824 0.800 QC Low 1 4.807 4.975 5.136 5.217 5.508 5 2 4.70 4.85 4.36 4.80 4.27 8.62 -4.30 3 3.88 4.44 4.84 5.06 4.95 QC Med 1 154.43 142.24 145.94 151.86 143.06 150 2 125.20 136.42 132.64 136.18 137.59 5.79 -4.48 3 147.09 152.21 146.18 152.05 146.01 QC High 1 289.01 277.16 275.32 271.04 276.14 300 2 281.57 280.50 265.73 287.29 278.00 4.51 -4.66 3 303.80 304.81 302.93 301.59 295.20 RMSCV 10.83 % RMSbias 4.23 % Combined Standard Uncertainty 11.62 %
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