血清酶在不同检测系统间测定的可比性研究

Bias estimation and comparative study on results of serum enzymes between cobas and vitros

目的通过对不同生化分析仪的检测系统进行方法比对和偏倚评估,探讨不同仪器间血清酶测定结果的可比性。方法参考NCCLS指南文件EP9-A,以罗氏Cobas C501作为目标检测系统(X),强生Vitros 350生化分析仪为待评系统(Y),对尿素氮(BUN)、肌酐(CREA)、尿酸(UA)、乳酸脱氢酶(LDH)进行检测,计算两个系统的相对偏差(%SE),以CLIA’88规定的室间质量评价允许误差范围的1/2为标准,进行系统间的比较试验,判断其可比性。结果 BUN、CREA、UA两系统间误差小于CLIA’88规定的允许误差的1/2,各检测项目在两仪器间的测量结果具有可比性,两系统间的系统误差能为临床所接受。LDH两系统间误差大于CLIA’88规定的允许误差的1/2,需进行比对试验校正后再进行比较。结论两检测系统多数酶测定结果之间具有可比性,能满足临床需求。

Objective To analyze the comparability of serum enzyme results of different biochemical detecting system were studied through bias estimation and method comparison. Methods Following NCCLS document EP9 - A, Cobas C501 biochemical analyzer as a target system, Vitros 350 biochemical analyzer as a comment system. The BUN,CREA, UA and LDH were analysed. It was judgement whether the results on different analysis systems were comparability according to the half of CLIA＇ 88 with calculation the system bias between target system and comment system. Results The system bias of BUN, CREA and UA were less than the half of CLIA＇ 88. The system bias of LDH was more than the half of CLIA＇ 88. Correlative experiment need to be done in LDH. Conclusion Most of the results between two analysis systems were comparable, and can satisfy clinical need.