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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: When the same quality control or serum sample is measured repeatedly 10 times, the coefficient of variation (CV%) of the measured values should not exceed 5%.
b, Inter-batch difference: The inter-batch difference of three randomly selected reagent kits should be ≤10%.
Linearity: Within the range of [0.1, 8.0] mg/L, the linear correlation coefficient r ≥ 0.990, the linear deviation within the range of [0.1, 2.0] mg/L should not exceed ±0.2 mg/L, and the measurement deviation within the range of (2.0, 8.0] mg/L should not exceed ±10%.
Sensitivity: When the sample concentration is 1.0 mg/L, the change in absorbance is between 0.0150 and 0.0700.
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