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Limit-of-Quantitation (Imprecision vs Concentration) AEROSET Limit of Quantitation (according to CLSI- EP17-A) (Bias <= 0.05 mg/L and CV% <= 20%) Target Conc. mg/L Found Conc. mg/L Bias mg/L SD mg/L CV% 1 0.006 0.002 -0.004 0.004 310.8% 2 0.017 0.020 0.003 0.012 62.4% 3 0.029 0.027 -0.002 0.007 25.0% 4 0.051 0.057 0.006 0.007 11.8% 5 0.096 0.097 0.001 0.009 9.8% 6 0.142 0.141 -0.001 0.007 5.2% 7 0.187 0.179 -0.008 0.013 7.2% 8 0.232 0.237 0.005 0.013 5.3% ARCHITECT c8000 Limit of Quantitation (according to CLSI- EP17-A) (Bias <= 0.05 mg/L and CV% <= 20%) Target Conc. Found Conc. Bias mg/L SD mg/L CV% 1 -0.004 0.002 0.006 0.006 316,3% 2 0.008 0.009 0.001 0.006 63,1% 3 0.019 0.016 -0.003 0.005 32,3% 4 0.042 0.044 0.002 0.005 11,8% 5 0.087 0.090 0.003 0.008 9,1% 6 0.132 0.129 -0.003 0.003 2,5% 7 0.178 0.174 -0.004 0.007 4,0% 8 0.223 0.227 0.004 0.005 2,1% Results: Sensitivity Limit-of-Blank and Limit-of-Detection: (Specimen: Saline) AEROSET Limit of Blank and Limit of Detection Mean (mg/L) SD (mg/L) LOB (mg/L) Mean + 1.645 x SD LOD (mg/L) Mean + 3 x SD Run 1 (n=20) 0.008 0.012 0.027 0.042 Run 2 (n=20) 0.007 0.012 0.027 0.044 Run 3 (n=20) 0.007 0.011 0.025 0.041 N= 60 0.007 0.012 0.026 0.042 ARCHITECT c8000 Limit of Blank and Limit of Detection Mean (mg/L) SD (mg/L) LOB (mg/L) Mean + 1.645 x SD LOD (mg/L) Mean + 3 x SD Run 1 (n=20) 0.005 0.008 0.019 0.030 Run 2 (n=20) -0.003 0.010 0.017 0.031 Run 3 (n=20) -0.008 0.006 0.010 0.018 N= 60 -0.002 0.010 0.016 0.029 Results: Total Imprecision AEROSET Total Imprecision Between Days Within Run N Mean (mg/L) SD (mg/L) CV% SD (mg/L) CV% SD (mg/L) CV% Level 1 40 0.60 0.026 4.3 0.013 2.2 0.021 3.6 Level 2 40 0.88 0.025 2.9 0.010 1.1 0.019 2.1 Level 3 40 1.13 0.021 1.9 0.008 0.7 0.015 1.4 ARCHITECT c8000 Total Imprecision Between Days Within Run N Mean (mg/L) SD (mg/L) CV% SD (mg/L) CV% SD (mg/L) CV% Level 1 40 0.58 0.012 2.1 0.000 0.0 0.010 1.7 Level 2 40 0.84 0.017 2.0 0.007 0.9 0.007 0.8 Level 3 40 1.12 0.022 1.9 0.005 0.4 0.006 0.5 Results: On board calibration stability On Board Reagent Stability On Board Calibration Stability Target: up to 6 weeks up to 4 weeks Criteria: Max bias vs initial measurement: 0.10 mg/L Max % bias vs initial measurement: 10% Linearity on ARCHITECT c8000 at two Cystatin C Concentration Ranges Full measuring range: from 0.88 mg/L to 8.85 mg/L Clinically relevant measuring range (around clinical decision level of 1.10 mg/L): from 0.18 mg/L to 1.99 mg/L (3 replicates x 11 dilution levels) Elaboration according CLSI EP6-P2 – Analyse-it vs2.04) Results: Linearity Linearity on Aeroset at two Cystatin C Concentration Ranges Full measuring range: from 1.00 mg/L to 9.46 mg/L Clinically relevant measuring range (values around the clinical decision level of 1.10 mg/L): from 0.21 mg/L to 1.97 mg/L (3 replicates x 11 dilution levels) Elaboration according CLSI EP6-P2 – Analyse-it vs2.04) X PENIA PENIA PETIA I (H912) PETIA II (H912) SCH (Aeroset) Y SCH (Aeroset) SCH (c8000) SCH (c8000) SCH (c8000) SCH (c8000) N 80 80 80 80 80 Range (mg/L) 0.57 – 9.84 0.57 – 9.84 0.64 to 7.61 0.57 – 9.51 0.63 – 9.61 Slope (95% CI) 1.00 (0.97 to 1.03) 1.02 (1.00 to 1.05) 1.22 (1.16 to 1.27) 0.993 (0.98 to 1.01) 1.02 (1.01 to 1.03) Intercept (95% CI) 0.11 (-0.6 to 0.28) 0.06 (-0.08 to 0.20) -0.18 (-0.44 to 0.09) -0.00 (-0.10 to 0.10) -0.03 (-0.10 to 0.05) R 0.992 1.00 0.983 0.997 0.998 Sy/x 0.338 0.286 0.507 0.201 0.150 PLOT 1 2 3 4 5
