实现自建检测系统与标准检测系统检验结果的可比性

目的探讨实现自建检测系统与标准检测系统检验结果可比性的方法。方法以日立7600生化分析仪、罗氏试剂及测定程序、cfas校准品及罗氏质控品为标准检测系统,通过患者新鲜混合血清量值传递,将自建检测系统的cfas校准品的标示值转换为校正自建检测系统＂雅培C8000生化分析仪/上海科华试剂及测定程序＂的实际校正值。同时,参照美国临床实验室标准化委员会（NCCLS）EP-9A文件,用患者新鲜血清分别对cfas校准品量值传递前、后的自建检测系统与标准检测系统作7项常见血清酶[丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）、碱性磷酸酶（ALP）、γ-谷氨酰基转移酶（GGT）、肌酸激酶（CK）、乳酸脱氢酶（LDH）、淀粉酶（AMY）]的比对试验,并对测定结果进行统计分析和偏倚评估,以系统间偏倚小于美国临床实验室修正法案（CLIA＇88）允许误差的1/4作为校正是否成功、系统间偏差临床是否可接受的标准。结果量值传递前各项目在2种检测系统上的相关系数（r）≥0.975,ALT、GGT在2种检测系统上的相对偏差（SE%）〉1/4 CLIA＇88,临床不能接受;量值传递后各项目在2种检测系统上检测结果经线性回归分析,其r和线性方程斜率（a）、截距（b）均有不同程度的改善,所有项目的SE%≤1/4 CLIA＇88,临床全部可接受。结论经量值传递后的患者定值血清可用来校正自建检测系统,可以提高自建检测系统检测结果的量值溯源性,从而实现自建检测系统与标准检测系统检验结果的可比性。

The comparability on the results of a self-developed biochemical testing system and standard testing system

Objective To investigate a method to achieve the comparability on the results of a self-developed biochemical testing system and a standard testing system.Methods The standard testing system was composed of Hitachi 7600 automatic biochemical analyzer,Roche reagent,Roche cfas calibrator and Roche quality control.The quantity was transmitted into the fresh mixed patients′ sera.The indicative value of the cfas calibrator was transferred into the actual value on the ARCHITECT C8000/Shanghai Kehua system,which was then regarded as the calibrator to evaluate self-developed testing system.Following National Committee for Clinical Laboratory Standards（NCCLS） document EP-9A,a comparative study between 2 testing systems was performed by detecting 7 serum enzyme items [alanine aminotransferase（ALT）,aspartate aminotransferase（AST）,alkaline phosphatase（ALP）,gamma-glutamyltransferase（GGT）,creatine kinase（CK）,lactate dehydrogenase（LDH） and amylase（AMY）].The results were analyzed,and the bias was evaluated.The allowable error within the 1/4 standard of Clinical and Laboratory Standards Institute（CLIA）′88 was acceptable.Results Before quantity transmitting,the correlation coefficient（r） was ≥0.975 between 2 testing systems.The system error（SE%） of ALT and GGT was1/4 CLIA′88 and was not acceptable.After quantity transmitting,the results were analyzed by regression,and the values of r,linear equation slope rate（a） and intercept（b） were improved.The SE% was ≤1/4 CLIA′88,which could be accepted.Conclusions After quantity transmitting,using fresh mixed serum can calibrate a self-developed testing system.The traceability and comparability can be improved between self-developed testing system and standard testing system.