部分生化项目不同检测系统测定结果的比对分析和偏倚评估

Comparative analysis and bias assessment on results of partial biochemical items detected by different biochemical testing systems

目的:通过对同一实验室不同检测系统测定结果的比对分析和偏倚评估,探讨各检测系统之间检测结果是否具有可比性。方法:按照NCCLS EP9-A2文件的要求,以检测系统1(X):日立7600全自动生化分析仪P1模块,迈克试剂,c.f.a.s.校准品和BIO RAD质控品作为目标检测系统,检测系统2(Y1)和检测系统3(Y2)作为比较检测系统,在各自系统中通过检测病人新鲜血清天门冬氨酸转氨酶(Aspartate aminotransferase,AST)、丙氨酸氨基转移酶(Alamine aminotransferase,ALT)、γ-谷氨酰转移酶(Gamma-glutamyl transferase,GGT)、碱性磷酸酶(Alkaline phosphatase,ALP)、尿素(Urea)、肌酐(Creatinine,Cr)、尿酸(Uricacid,UA)水平来计算比较检测系统和目标检测系统之间的相对偏差(%SE),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误差范围的1/2为标准,判断各检测系统间测定结果的临床可接受性。结果:各检测系统间检测结果显著相关(r2>0.95),临床可接受性能评价中检测系统2(Y1)Urea低浓度水平时SE%>1/2CLIA’88TEa,与检测系统1(X)不具有可比性,其余各项测定结果偏倚评估临床可接受。结论:除低水平Urea外,AST、ALT、GGT、ALP、Cr、UA检测结果在我院3套检测系统间具有可比性。

Objective：To investigate the comparability among different biochemical testing systems in the same laboratory by performing the comparative analysis and bias estimation on the results.Methods：According to NCCLS document EP9-A2,3 biochemical testing systems including system 2 and 3（Y1-Y2,comparative testing systems） and system 1（X,targeted testing system,which was composed of Hitachi 7600 biochemical analyzer P1,maker reagents,c.f.a.s.calibrator and BIO RAD quality control） were used to obtain correlation coefficient and linear regression equation.The values of aspartate aminotransferase（AST）,alamine aminotransferase（ALT）,gamma-glutamyl transferase（GGT）,alkaline phosphatase（ALP）,Urea,creatinine（Cr） and uric acid（UA） in patient’s serum were detected by the three systems.Then the coefficient and the equation were used to evaluate the system bias between comparative testing systems and targeted testing system.The comparability of different testing systems was judged by half of the CLIA’88 standard.Results：The results of the three testing systems were significantly correlated（r2〉0.95）.The results of all testing items showed good comparability except those of Urea（with low concentration level） tested by system 2（Y2） and system 1（X）（%SE〉1/2CILA’88 TEa）.Conclusions：There is good comparability among the results of AST、ALT、GGT、ALP、Cr、UA detected by different testing systems in our hospital except those of Urea with low concentration level.