摘要
目的对新上市的雅培降钙素原(procalcitonin,PCT)磁微粒化学发光检测试剂进行性能评估。方法参照中国卫生行业标准及美国临床和实验室标准协会(Clinical and Laboratory Standards Institute,CLSI)文件要求,以法国梅里埃PCT测定试剂盒为参比试剂,从精密度、线性范围、正确度、参考区间等方面分析雅培i2000化学发光分析仪检测PCT的性能。结果雅培i2000化学发光分析仪检测PCT的批内精密度低值和高值的变异系数(coefficient of variation,CV)分别为2.5%和2.4%,批间精密度低值和高值的CV分别为3.0%和3.1%。线性范围为0~100ng/ml,相关系数r^(2)=0.9923,满足行业标准。生物参考区间为≤0.05ng/ml。雅培i2000与梅里埃mini VIDAS相比,检测结果普遍偏低,存在明显的负偏倚。结论雅培i2000化学发光分析仪检测PCT整体性能良好,能满足实验室的工作要求,但实验室在开展PCT检测及更换检测方法时应进行性能验证和方法学比对研究。
Objective To analyze the performance of Abbott i2000 chemiluminescence analyzer for the determination of procalcitonin(PCT).Methods Reference to the Chinese health industry standards and the Clinical and Laboratory Standards Institute(CLSI)documentation requirements,using the French BIOMERIEUX PCT assay kit as reference reagent,the performance of Abbott i2000 chemiluminescence analyzer for the detection of PCT was analyzed from the aspects of precision,linear range,accuracy and reference interval.Results The Abbott i2000 chemiluminescence analyzer measured PCT with in-batch coefficients of variation(CV)for low and high precision values of 2.5%and 2.4%,and inter-batch CV for low and high precision values of 3.0%and 3.1%,respectively.The linear range was 0-100ng/ml,and the correlation coefficient r^(2)was 0.9923,in line with the industry standard.The biological reference interval was≤0.05ng/ml.The results of Abbott i2000 were generally lower than those of BIOMERIEUX mini VIDAS,with obvious negative bias.Conclusions The Abbott i2000 chemiluminescence analyzer has a good overall performance in PCT detection,which can meet the requirements of the laboratory.However,the laboratory should conduct performance verification and methodology comparison study when carrying out the detection of PCT and changing the detection methods.
作者
商希鹏
李莎
张福阳
刘旭
SHANG Xipeng;LI Sha;ZHANG Fuyang;LIU Xu(Laboratory Department,the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,NationalClinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China)
出处
《中国现代医生》
2022年第34期70-74,共5页
China Modern Doctor
关键词
降钙素原
化学发光法
性能评估:方法学比对
Procalcitonin
Chemiluminescence method
Performance evaluation
Methodological comparison
