3种不同方法检测11项常见临床生化指标的结果对比

Comparison of testing results of 11 common biochemical indexes detected by 3 different methods

目的分析比对3种不同检测系统在11项常见临床生化指标的检测结果的可比性。方法以OLYMPUS AU2700检测系统(X)为比较方法,HITACHI 7020检测系统(Y1)、CHEMIX-800检测系统(Y2)为试验方法,并根据美国临床实验室标准化委员会制定的NCCLS EP9-A2文件作为判断依据,检测患者新鲜血清中11项常规生化指标(总胆固醇、三酰甘油、丙氨酸氨基转移酶、葡萄糖、肌酐、尿素、尿酸、天门冬氨酸氨基转移酶、γ-谷氨酰转移酶、碱性磷酸酶、乳酸脱氢酶),回归分析不同系统的相对偏差或医学决定水平处的系统误差,探讨检测系统间的可比性。结果检测系统(Y1)和检测系统(Y2)的尿素与检测系统(X)存在正偏差分别为8.4%和10.2%,差异有统计学意义(P<0.05),不具可比性。两种待评系统其他项目在医学决定水平处的预期偏差均小于实验室可接受偏差,与比对系统有可比性(P>0.05)。结论该实验室3个生化检测系统结果的可比性较好,但某些项目仍存在偏差,当同一项目应用不同系统检测时应评价其临床可接受性,确保检验结果的可比性。

Objective To analyze and compare the comparability of detecting results of 11 routine biochemical indexes by 3 different testing systems.Methods The values of 11 routine biochemical items in patients′serum were detected by three testing systems.The OLYMPUS AU2700 biochemical testing system(X)served as the comparative method,while the Hitachi 7020 testing system(Y1)and CHEMIX-800 testing system(Y2)as the experimental method.According to the NCCLS EP9-A2 files as the judgment criterion,11 conventional biochemical indexes in fresh serum were detected,including total cholesterol,triacylglycerol,ALT,glucose,creatinine,urea,uric acid,AST,γ-GGT,AKP and LDH,the relative deviation of different systems or system error at medical decisions level were analyzed by using regression method.Then the comparability of the three different biochemical testing systems was investigated.Results The positive deviation for detecting urea existed between the detecting system(Y1)and detecting system(Y2)with the detecting system(X),which were 8.4%and 10.2%respectively,and difference was statistically significant and not comparble(P<0.05).The expected deviation of the other items in the two evaluation systems at the medical decision level were less than the laboratory acceptable deviation,which had the comparability with the comparative system(P>0.05).Conclusion The results of the 3 biochemical testing systems in this laboratory have good comparability,while some items still have deviations.It is necessary to evaluate the clinical acceptability for ensuring the comparability of detecting results when the same index is detected by different detecting system.