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Performance Indicators

Accuracy: Determined using quality control products, the average of the measured results should be within the target value range of the quality control products.

Precision: a, Repeatability: For the same serum sample or quality control product at different concentrations, repeated measurements are performed 10 times, and the coefficient of variation (CV%) of the measured values should not exceed 5%.

b, Inter-batch difference: The inter-batch relative range of three randomly selected reagent kits should be ≤10%.

Linearity: Within the range of [0.1,180] μmol/L, the linear correlation coefficient r ≥ 0.99, within the range of [1.0,20] μmol/L the linear deviation should not exceed ±2 μmol/L within the range of (20,180] μmol/L the measurement deviation should not exceed ±10%.

Sensitivity: When the sample concentration is 40 μmol/L the change in absorbance is between 0.0200 and 0.0800.