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Performance Indicators

Blank absorbance: The blank absorbance measured at A340nm (main) / A405nm (secondary) should be ≤1.5000.

Accuracy: Using quality control products for determination, the average of the measured results should be within the target value range of the quality control product.

Precision: a, Repeatability: For the same serum sample or quality control product at different concentrations, repeated measurements 10 times, 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 randomly selected reagent kits should be ≤12%.

c, Intra-bottle precision of calibrator (0 concentration value point is not involved in the detection): Intra-bottle precision of calibrator should be ≤10%.

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

Linearity: Within the range of [1.0, 40.0]μg/mL, the linear correlation coefficient r≥0.990, the linear deviation within the range of [1.0, 10.0]μg/mL should not exceed ±1.5μg/mL, and the measurement deviation within the range of (10, 40.0]μg/mL should not exceed ±15%.

Sensitivity: When the sample concentration is 10μg/mL, the change rate of its absorbance ≥0.0020.