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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: When the same quality control or serum sample is measured repeatedly 10 times, the coefficient of variation (CV%) of the measured values should be ≤5%.
b, Inter-batch difference: The inter-batch difference of three randomly selected reagent kits should be ≤10%.
Linearity: Within the range of [20, 100] U/mL, the linear correlation coefficient r ≥ 0.990. Within the range of [20, 50] U/mL, the linear deviation should not exceed ±5 U/mL, and within the range of (50, 100] U/mL, the measurement deviation should not exceed ±10%.
Sensitivity: When the sample concentration is 60 U/mL, the change in absorbance is between 0.1500 and 0.6500.
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