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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: The same serum sample or quality control product at different concentrations is measured repeatedly 10 times, and the coefficient of variation (CV%) of the measured values should not be greater than 10%.

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

c, Intra-bottle precision of calibrator: The intra-bottle precision of the calibrator should be ≤10%.

d, Inter-bottle precision of calibrator: The inter-bottle precision of the calibrator should be ≤10%.

Linearity: Within the range of [2.0, 100.0] mg/L, the linear correlation coefficient r ≥ 0.990, Within the range of [2.0, 20.0] mg/L, The linear deviation should not exceed ±4 mg/L ， Within the range of (20.0, 100.0] mg/L, the linear relative deviation should not exceed ±15%.

Sensitivity: When the sample concentration is 40 mg/L, the change in absorbance should be > 0.010.