不同检测系统21项常规生化结果的比对与临床可接受性评价  

The contrast and clinical acceptability estimation on the result of routine biochemistry items in different biochemical testing systems

作　　者：刘怀平[1] 孙金芳[1] 陈欣[1] 庞国菊[1] 高秀登[1] 王剑[1] 付丽娜[1] 

机构地区：[1]天津市第三中心医院检验中心,天津300170

出　　处：《中国实验诊断学》2009年第10期1406-1409,共4页Chinese Journal of Laboratory Diagnosis

摘　　要：目的探讨不同检测系统间常规生化结果的可比性,为本实验室不同检测系统检验结果的互认和实验室认可提供依据。方法参考美国临床实验室标准化委员会(NCCLS)的EP9-A2文件,以Modular P-800检测系统为目标,用患者新鲜血清对不同实验(自建)检测系统的21项常规生化结果与目标检测系统进行比对,计算实验检测系统(Y)和目标检测系统(X)之间的相对偏差,以美国临床医学检验部门修正法规(CLIA′88)允许总误差的1/2为标准,判断检验结果的可比性。结果实验检测系统1的总蛋白(TP)、谷丙转氨酶(ALT)、碱性磷酸酶(ALP)、直接胆红素(DBil)、尿素(Urea)、无机磷(P)与目标系统不具可比性,实验检测系统2的r-谷氨酰基转移酶(GGT)、DBIL、尿酸(UA)、三酰甘油(TG)、P与目标检测系统不具可比性,实验检测系统3的所有21个项目与目标检测系统均具可比性。结论实验检测系统与目标检测系统的常规生化结果依项目不同存在不同程度的偏差;当用2个以上的检测系统检测同一检验项目时,应进行方法比对和临床可接受性评价,以实现检验结果的可比性。Objective To study the results comparability of different biochemical testing systems by clinical acceptability estimation and method comparison.Methods According to National Committee for Clinical laboratory Standards（NCCLS）document EP9-A2,21 biochemistry items in different experimental（self-built） biochemical testing system and aim system were tested respectively to obtain the correlation coefficient and the linear equation.Then the system bias between experimental testing system and aim system could be evaluated by obtained equation.The comparability of different investigated system was judged according to the half of clinical laboratory improvement amendment 88（CLIA＇88）allowed total error.Results The results of total protein（TP）,alanine aminotransferase（ALT）,alkaline phosphatase（ALP）,direct bilimbin（DBil）,Urea and inorganic phosphate（P）tested in system 1 and aim system showed no comparability.The results of glutamy itransferase（GGT）,DBil,uric acid（UA）,triglycefides（TG）and P tested in system 2 and aim system showed no comparability.There was comparability between system 3 and aim system in all items.Conclusion Routine biochemistry results had different bias between experimental（self-built） testing system and Roche Modular P-800 system.If the same item is tested in more than two systems.it is necessary to judge clinical acceptability by method comparison and clinical acceptability estimation so as to insure the comparability.

关 键 词：可接受性评价 方法比对 实验室认可 质量管理 

分 类 号：R446.1[医药卫生—诊断学]