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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 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 [3, 5000] ng/mL, the linear correlation coefficient r² ≥ 0.990. Within the range of [3, 100] ng/mL, the linear deviation should not exceed ±30 ng/mL; within the range of (100, 5000] ng/mL, the measurement deviation should not exceed ±10%.
Sensitivity: When the sample concentration is 600 ng/mL, the change in absorbance is between 0.0200 and 0.1500.
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