以CLSI EP15-A2指南验证生化分析系统的精密度和正确度

Validation of the accuracy and accuracy of biochemical analysis systems using the CLSI EP15-A2 guidelines

目的利用CLSI EP15-A2指南对本科购置的日立公司生产7600生化分析仪测定Urea、UA、Chol精密度和正确度进行验证,为保证临床实验室质量管理水平提供指导。方法根据CLSI EP15-A2文件评价实验室生化分析系统性能的实验设计,每天对2个不同浓度水平的质控分别测定3次,共测定5 d,计算测定的Urea、UA、Chol重复性标准差(Sr)和实验室内标准差(Sl),并与厂家提供的指标比较,如实验数值小于厂家指标值,则验证通过。正确度验证则是对同一实验批次内2个不同浓度的质控品重复测定2次,共测定5天。测定均值与靶值的偏差小于卫生部临床检验中心室间质评的允许误差,则正确度验证通过。结果 7600测定Urea、UA、Chol的重复性标准差和实验室内标准差均达到厂家提供的指标。正确度验证中测定L1时,Urea、UA、Chol的均值分别是20. 99 mmol/L、535. 34μmol/L、3. 64 mmol/L,测定L2时Urea、UA、Chol均值分别是9. 50 mmol/L、268. 2μmol/L、7. 83 mmol/L,与靶值的偏倚均小于行业标准。结论根据CLSI EP15-A2文件验证7600生化分析仪精密度和正确性是较为可靠的方法,其实验简单方便,适合方法的性能指标的验证,建议推广应用。

Objective:To verify Urea,UA,Chol precision and accuracy of 7600 biochemical analyzer of Hitachi's production purchased by our department by the use of CLSI EP15-A2 guidelines,and provide guidance for improving the level of quality management in clinical laboratory.Methods:The evaluation of the performance design method for laboratory analysts was made based on CLSI EP15-A2 documents.The quality control of 2 different levels was measured 3 times each day for a total of 5 days,and standard deviation(Sr)and laboratory standard deviation(Sl)of Urea,Chol,UA,repeatability were calculated,and compared with the index provided by the manufacturer's,and if the manufacturer's were less than the calculated values,the verification was donw.In 2 batches of different quality control samples,the quality control was repeated 2 times in the same batch,and 5 days were measured.The deviation between the mean value and the target value was less than the allowable error of the laboratory quality evaluation of the clinical laboratory center of the Ministry of health,and the verification was done.Results:The detections of 7600 biochemical analyzer in the repeatability standard deviation of Urea,UA and Chol and the standard deviation in laboratory were all up to the indexes provided by the manufacturer.In the accuracy test,the detections of L1,Urea,UA and Chol were 20.99 mmol/L,535.34 mol/L and 3.64 mmol/L.In the detection of L2,the average values of Urea,UA and Chol were 9.50mmol/L,268.2 mol/L,7.83 mmol/L respectively,and the target bias values were less than the industry standard.Conclusion:The CLSI EP15-A2 document is a reliable method to verify the precision and correctness of the 7600 biochemical analyzer.The experiment is simple and convenient,and it is suitable for the verification of the performance index of the method.