目的：探讨血清肌酸激酶（CK）、天门冬氨酸氨基转移酶（AST）、乳酸脱氢酶（LDH）3项指标在2种生化分析系统间检验结果的可比性，为实验室2种生化分析系统检验结果互认和实验室认可提供依据。方法取2个不同浓度的质控品分别在2种生化分析仪进行批内和批间精密度检测，并以厂商注明和该实验室设定的精密度要求为评估标准，再依照美国临床实验室标准化协会（CLSI）的EP9‐A2文件，分别测定100例患者血清CK、AST、LDH的含量，计算2种方法的相对偏倚（SE％）。然后以美国临床实验室修正法规（CLIA′88）规定的室间质量评价允许总误差范围的1／2为临床可接受判断标准，评估两种生化分析系统对CK、AST、LDH检测结果的一致性。结果2种生化分析系统对CK、AST、LDH检测的批内变异系数和批间变异系数均低于厂商注明和该实验室设定的精密度要求，且结果与临床诊断相符，实验结果比对可靠。除LDH在低医学决定水平处的SE％超过了临床可接受判断标准，其余项目均低于可接受限，2种生化分析系统结果一致。结论当有2个检测系统对同一检验项目进行检测时，应进行比对分析和偏倚评估，以保证检验结果的准确性和可比性。%Objective To discuss the comparability and bias evaluation on the results of serum creatine kinase (CK ) ,aspartate aminotransferase (AST) ,lactate dehydrogenase (LDH) inspection results between the two different kinds of biochemical analysis system .Methods The control quality materials with two concentration were detected respectively for degree of precision ,and the assessment standard was from manufacturer introductions and laboratory setting .Then in accordance with American Clinical and Laboratory Standard Institute(CLSI) document EP9‐A2 ,100 patients serum CK、AST、LDH were detected .Afterwards the relative bias(SE% ) was calculated ,and the comparative analysis bias evaluation was judged according to the half of CLIA′88 allowed total error .Results The variable coefficients mainly conformed to the requirements ,and the experimental results were reliable .The oth‐ers mainly lower than the acceptable limit besides SE% for LDH higher than it .Conclusion It is necessary to execute comparative analysis and bias evaluation to ensure the accuracy and comparability if the same item is detected in two analysis system .
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