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SAA Reagent Kit
performance index
Accuracy: The quality control product is used for measurement. The average value of the measurement results should be within the range of quality control target values.
Precision: a, repeatability: repeated determination of the same serum sample or quality control at different concentrations 10 times, and the coefficient of variation(CV %) of the measured value should not be greater than 10 %.
B, interbatch difference: the relatively poor inter-batch(R) for randomly selecting three batch kits should ≤ 10 %.
C, calibration bottle precision density: calibration bottle precision density should ≤ 10 %.
D, calibrate the precision between bottles: calibrate the precision between bottles should ≤ 10 %.
Linear: in[ 2.0, 100.0] In the mg/L range, the linear correlation coefficient R ≥ 0.990, in[ 2.0, 20.0] Within mg/L, the linear deviation should not exceed ± 4 mg/L at(20.0.100.0) Within the mg/L range, the linear relative deviation should not exceed ± 15 %.
Sensitivity: When the sample concentration is 40 mg/L, the absorbance change should > 0.010.