两家医院不同检测系统间部分血清酶测定结果可比性分析

Analysis on comparability of part of the detecting results of serum enzyme by different detection systems in two hospitals

目的分析两家医院不同检测系统间部分血清酶测定结果的可比性。方法按EP9-A2文件要求,采用日立7080生化分析仪、罗氏试剂、Cfas校准品、质控品组成的检测系统作为目标检测系统,两家医院其他不同检测系统1～3作为实验系统,分别对患者丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、γ谷胺酰转肽酶(GGT)、碱性磷酸酶(ALP)进行检测;通过计算实验方法(Y)与参比方法(X)之间的相对偏差(SE%),对不同检测系统间测定结果的可比性进行判断,当预期偏差不能接受时,用新鲜混合血清赋值后再用新的校准值校准自建检测系统。结果除检测系统2的GGT结果与参比方法系统误差大不能被接受外,其余测定结果的系统误差可被临床接受,检测系统2的GGT经重新赋值后,与参考检测系统的偏差减小,结果可以接受。结论不同医院间不同检测系统对同一项目进行检查时,应进行方法比对和偏倚评估后进行临床可接受性判断,通过新鲜血清对日常校准品重新赋值,可以确保不同检测系统检验结果的可比性。

Objective To analyze the comparability of detecting results of serum enzyme by different detection systems in different hospitals. Methods According the reference standard in NCCLS EP9-A2, the system consisted Hitachi 7080 biochemical analyzer, Roche reagents, Cfas calibrator and quality control materials was the target de- tection system. The other one to three detection systems in the two hospitals were the experimental system. The lev- els of alanine aminotransferase （ALT）, alkaline phosphatase （ALP）, aspartate aminotransferase （AST）, and gam- ma-glutamyl transferase （GGT） were detected. The relative deviation （SE %） between laboratory method （Y） and comparison method （X） was used to judge the comparability of different detection systems. When the bias was not acceptable, a fresh mixed serum was assayed, and the result was adopted as temporary calibrator of the detection system. Results In addition to the bias of C-GT result of detection system 2 was too great, and the result was unac- ceptable. The results of the other detection system were acceptable. After the temporary calibrator using, the bias was significantly decreased and acceptable in system 2. Conclusion The same samples detected by different detection systems in different hospitals should be performed in method comparison and bias evaluation to conduct clinical ac- ceptability. The deassign using fresh mixed serum can ensure the comparability of different systems.