Roche Modular DPP全自动生化分析仪与Vitros350干片式生化仪测定心肌酶结果的比对与校正

Comparison and correction on the results of myocadial enzyme detected by Roche Modular DPP automatic biochemical analyzer and Vitros350 dry type biochemical analyzer

目的探讨Roche Modular DPP全自动生化分析仪与Vitros350干片式生化分析仪测定心肌酶结果的可比性,对误差进行校正,为不同生化系统测定心肌酶结果的可比性及临床可接受性提供依据。方法依照美国临床实验室标准化委员会(NCCLS)EP9-A文件,以Roche Modular DPP全自动生化分析仪为参考方法(X),以Vitros350干片式生化仪为实验方法(Y),求出相关回归方程,对两台生化仪测定心肌酶(ALT、AST、LDH、CK、CK-MB)的结果进行比对分析,并依照美国实验室修正法规(CLIA'88)的标准判定两台仪器测定心肌酶结果的临床可接受性,对有明显偏差的项目进行校正。结果两台生化仪测定CK的结果一致,误差可被临床接受,而ALT、AST、LDH、CK-MB的检测结果差异较大,误差有统计学意义(P<0.05),需进行比对校正,校正后两台生化仪所测心肌酶结果可比性良好,误差可被临床接受。结论不同生化系统检测心肌酶时,必须进行比对及校正,以确保结果的一致性、可比性,使误差能被临床接受。

Objective To study the comparability of the myocardial enzyme results detected by Roche Mod-ular DPP automatic biochemical analyzer and Vitros350 dry type biochemical analyzer, and correct the deviation, and to provide basis for the comparability and clinical acceptability of myocardial enzyme results detected by different bio-chemical systems. Methods According to the Document EP9-A2 of the National Committee for Clinical Laboratory Standards （NCCLS）, taking Roche Modular DPP automatic biochemical analyzer as the reference method （X）, and Vit-ros350 dry type biochemical analyzer as the experimental method （Y）, the correlation regression equation was calcu-lated. The results of myocardial enzyme （ALT, AST, LDH, CK, CK-MB） detected by the two instruments were com-pared. Based on the standard of United States of America clinical laboratory （CLIA＇88）, the clinical acceptability was assessed and the items with obvious deviation were corrected. Results Among the results of myocardial enzyme that detected by the two biochemical analyzers, the results of CK were in accordance and the deviations could be accepted clinically. However, the results of ALT, AST, LDH, CK-MB had significant differences and the deviations were of statis-tical significance （P〈0.05）, which needed to be corrected. After correction, the results showed fine comparability and the bias could be accepted by clinic. Conclusion To ensure the accordance, comparability and the clinical acceptability, the results of myocardial enzyme detected by different biochemical systems need to be compared and corrected.