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Performance Indicators
Accuracy: Determined using quality control products. The average of the measured results should fall within the target range of the quality control products.
Precision: a, Repeatability: When the same serum sample is measured repeatedly 10 times, the coefficient of variation (CV%) of the measured values should not exceed 10%.
b, Inter-batch difference: The inter-batch difference of three randomly selected reagent kits should be ≤10%.
Linearity: Within the range of [10,200] mg/dL, the linear correlation coefficient r²≥0.99. The linear deviation within the range of [10,20] mg/dL should not exceed ±2 mg/dL, and the measurement deviation within the range of (20,200] mg/dL should not exceed ±10%.
Sensitivity: When the sample concentration is 60 mg/dL, the absolute value of the rate of change in absorbance per minute is between 0.01 and 0.10.
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