新型国产电化学发光分析仪检测降钙素原的性能评价

Performance Evaluation of a New Domestic Electrochemiluminescence Analyzer for Detection of Procalcitonin

目的:对某新型国产电化学发光分析仪检测降钙素原(PCT)的性能进行评价。方法:在深圳普门eCL8000全自动电化学发光分析仪上检测PCT,对其携带污染率、批内精密度、日间精密度及线性范围进行评估,并与某进口品牌电化学发光法检测PCT进行相关性分析。结果:普门电化学发光法检测PCT的携带污染率为0.02%,样本间交叉污染小,检测高、低浓度的样本的批内精密度CV分别为0.95%、2.8%,高、低浓度的样本的日间精密度CV分别为1.88%、3.25%,PCT在0~88.6ng/mL浓度范围内线性好(Y=1.0412X-0.9901,R2=0.9977),普门eCL8000全自动电化学发光分析仪检测系统与某进口品牌检测系统测定PCT的结果呈明显相关(Y=1.1272X-0.0991,R2=0.9997)。结论:普门eCL8000电化学发光分析仪检测系统测定PCT的性能优越,可供临床实验室使用。

Objective:To evaluate the performance of a new domestic electrochemiluminescence analyzer for the detection of procalcitonin(PCT).Methods:PCT was detected on the eCL8000 automatic electrochemiluminescence analyzer in Shenzhen,and its carrying pollution rate,intra batch precision,inter day precision and linear range were evaluated,and the correlation between PCT detection by an imported brand was analyzed.Results:The carrying contamination rate of PCT was 0.02%,and the cross contamination between samples was small.The intra assay precision CV of high and low concentration samples were 0.95%and 2.8%,respectively.The inter assay precision CV of high and low concentration samples were 1.88%and 3.25%,respectively.The linear range of PCT was 0-88.6ng/mL(Y=1.0412X-0.9901,R2=0.9977),There was a significant correlation between the results of PCT measured by the system and that of an imported brand(Y=1.1272X-0.0991,R2=0.9997).Conclusion:The performance of PCT detection system of pmen eCL8000 is superior,which can be used in clinical laboratory.