目的:探讨酶学参考方法应用于卫生部临床检验中心常规化学室间质评中的可行性。方法选取5个临床常规检测系统和参考方法同时检测临床检验中心2012年第1次室间质评样本和患者血清肌酸激酶(CK)、乳酸脱氢酶(LDH)、碱性磷酸酶(ALP)、丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、γ-谷氨酰基转移酶(GGT)、α-淀粉酶(AMY),将各临床常规系统检测结果与参考方法测量结果或临床检验中心靶值进行比较,计算相对偏倚。以临床检验中心室间质评允许误差的要求为标准,判断各系统各项目是否合格。结果参考方法测量质评样本结果与临床检验中心靶值的相对偏倚在±10%以内。用临床检验中心的允许总误差作为判断标准,以参考方法检测结果为参比,湿化学系统室间质评样本和患者血清合格率为100.0%;干化学系统室间质评样本和患者血清合格率分别为77.1%和97.1%。用临床检验中心酶学正确度验证的标准评价室间质评样本测量结果,以参考方法检测结果为参比,湿化学系统所有测量结果合格率分别为72.9%和63.6%。结论参考方法可以应用于室间质评,对解决临床检验结果的正确性提供了重要依据。
Objective To discuss the feasibility of enzymatic reference methods in Routine Chemistry external quality assessment (EQA)inlaboratorymedicine.Methods Samplesofthe1stEQAin2012byNationalCenterforClinicalLaboratories(NCCL)and patients′sera were measured by reference methods and 5 clinical analytic systems for the catalytic activity of CK ,LDH ,ALP ,ALT , AST ,GGT and AMY ,then the results of 5 clinical systems were compared with the reference methods′or target value of NCCL by calculating the bias ,and evaluated them according to the criteria of EQA by NCCL .Results The results of EQA samples measured by reference methods was within ± 10% compared with NCCL target value .Compared with the results of reference method ,the through put was 100 .0% for wet clinical chemistry systems measuring both EQA samples and patients′serum ,and the dry clinical chemistry systems was 77 .1 for EQA samples and 97 .1% for patients′serum according to the criterion of EQA ,and the through put was 72 .9% and 63 .6% of wet clinical chemistry systems according to the standard of enzymatic trueness of NCCL .Conclusion Reference method could be applied to EQA ,and will be a great help for the trueness of clinical testing .