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Performance Indicators
Accuracy: Determined using quality control products, the average of the measured results should be within the target range of the quality control product.
Precision: a, Repeatability: The same serum sample or quality control product at different concentrations is repeatedly measured 10 times, and the coefficient of variation (CV%) of the measured values should not be greater than 5%.
b, Inter-batch difference: The inter-batch relative range of three randomly selected reagent kits should be ≤10%.
Linearity: In the range of [1.5, 50.0] μmol/L, the linear correlation coefficient r ≥ 0.990, the linear deviation in the range of [1.5, 10.0] μmol/L should not exceed ±1.0 μmol/L, and the measurement deviation in the range of (10.0, 50.0] μmol/L should not exceed ±10%.
Sensitivity: When the sample concentration is 10.0 μmol/L, the absolute value of its absorbance change rate should be ≥0.0100.
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