三台雅培全自动免疫分析仪测定AFP、CEA水平的可比性研究  

Comparative Study on AFP and CEA Levels Detected by Three Abbott Automatic Immune Analyzers

作　　者：李泰阶[1] 李山[1] 秦雪[1] 董良哲[1] 李若林[1] 徐明辉[1] 陈智平[2] 

机构地区：[1]广西医科大学第一附属医院临床医学实验部广西医科大学检验系,广西南宁530021 [2]广西医科大学公共卫生学院,广西南宁530021

出　　处：《标记免疫分析与临床》2009年第2期111-113,共3页Labeled Immunoassays and Clinical Medicine

基　　金：广西卫生厅科研课题<临床检验仪器及方法学比对分析>(Z2008158)

摘　　要：探讨不同免疫分析仪检测AFP、CEA结果的可比性,为不同仪器检测结果的互认和实验室认可提供依据。依据美国临床实验室标准化委员会(NCCLS)EP9-A文件方案,收集40例患者不同浓度的新鲜血清,分别在三台仪器进行AFP、CEA检测,以雅培i2000SR为目标检测系统(X),用两台雅培AXSYM与目标系统进行比对,分析三台仪器检测结果的可比性。结果表明,雅培AXSYM(1)和雅培i2000SR的比对中,AFP浓度小于30 ng/mL、CEA浓度小于15 ng/mL时,预期偏倚和相对偏倚均在允许偏倚之外,结果不能被接受。雅培AXSYM(2)和雅培i2000SR的线性方程和相关系数都很好,结果可被接受。实验室内使用不同检测仪检测同一项目时,应进行方法的比对和偏倚评估,以实现检测结果的可比性。To explore the agreement of three different Abbott automatic immune analyzers for the detection of AFP and CEA, to provide the evidence for laboratory accreditation and result mutual accredit. Referring to the National Clinical Laboratory Standardization Committee （NCCLS） EP9 -A document, 40 serum samples from different patients were collected and CEA and AFP levels were determined by Abbott i2000SR and two Abbott AXSYM respectively. The concordance rates by two Abbott AXSYM were calculated and compared with Abbott i2000SR. The results showed that the anticipated bias and the relative bias of analysis results were out of the allowable bias when the samples by comparing serum AFP levels were less than 30 ng/mL or CEA levels were less than 15 ng/mL in Abbott AXSYM （1） with Abbott i2000SR. The results were not acceptable. The serum AFP and CEA levels detected by Abbott AXSYM （2） and Abbott i2000SR were in good linear relationship with high correlation coefficient. In order to achieve good results, methodology comparison and bias estimation were necessary when using different analyzers to detect the same items.

关 键 词：AFP CEA 可比性 全自动免疫分析仪 偏倚 

分 类 号：R446.61[医药卫生—诊断学]