普门电化学发光仪检测降钙素原的性能分析  

A Performance Analysis of Procalcitonin by Lifotronic Electrochemiluminescence Analyzer

作　　者：陈继德 汪志学 CHEN Ji-de;WANG Zhi-xue(Department of Clinical Laboratory,Bishan Hospital,Chongqing 402760,China)

机构地区：[1]重庆市璧山区人民医院检验科

出　　处：《标记免疫分析与临床》2019年第7期1224-1227,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：目的分析普门(Lifotronic)eCL8000电化学发光仪检测降钙素原(procalcitonin,PCT)的性能。方法以降钙素原(PCT)作为检测指标,根据临床和实验室标准协会(CLSI)文件要求从精密度、正确度(方法学比对)、线性范围、生物参考区间等方面评价普门eCL8000电化学发光仪的性能。结果普门eCL8000电化学发光仪检测PCT的批内精密度变异系数CV高低值分别为2.60%和2.11%,批间精密度CV值分别为3.92%和2.22%。PCT检测结果最大偏倚为14.29%(≤1/2TEa),且与参考方法拟合相关系数R^2=0.9977。线性范围相关系数R2=0.9993,生物参考区间为≤0.05ng/mL。结论普门eCL8000电化学发光仪检测PCT整体性能良好,能满足实验室的工作要求,可用于临床标本的检测。Objective To verify the performance of detecting procalcitonin(PCT)by Lifotronic eCL8000 electrochemiluminescence analyzer.Methods According to the American Society for Clinical and Laboratory Standards Institute(CLSI)series of documents,procalcitonin(PCT)was tested by eCL8000 analyzer for the measurement precision,accuracy,linear range,and biological reference intervals.Results The intra-assay imprecision CV values of eCL8000 for detection of PCT were 2.60% and 2.11%,respectively,and the inter-assay imprecision CV values were 3.92% and 2.22%,respectively.The maximum bias of the PCT test results was 14.29 %(≤1/2TEa).The correlation coefficient( R 2)of the accuracy was 0.9977.The correlation coefficient of the linearity analysis was 0.9993,and the biological reference interval was ≤0.05ng/mL.Conclusion The Lifotronic eCL8000 electrochemiluminescence analyzer has a good performance for detecting PCT,which can meet the laboratory requirements and can be used for the test of clinical specimens.

关 键 词：降钙素原 电化学发光 性能分析 

分 类 号：R446.6[医药卫生—诊断学]