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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 products.

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

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

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

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

e, Intra-bottle precision of the quality control product: The intra-bottle precision of the quality control product should be ≤10%.

f, Inter-bottle precision of the quality control product: The inter-bottle precision of the quality control product should be ≤10%.

Linearity: In the range of [15, 250] U/mL, the linear correlation coefficient r ≥ 0.99, the linear deviation in the range of [15, 150] U/mL should not exceed ±15 U/mL, and the measurement deviation in the range of (150, 250] U/mL should not exceed ±10%.

Sensitivity: When the sample concentration is 150 U/mL, the absorbance change rate ≥ 0.0010.