6家通过ISO15189认可医学实验室血清白蛋白检测结果一致性研究  

A Study on theMutual Recognition Consistency Results of Six Companies That Passed ISO15189 Accredited Medical Laboratory Serum Albumin Test

作　　者：林巧智 王德成 马嘉玮 王若冰 张瑜 管仲莹 LIN Qiaozhi;WANG Decheng;MA Jiawei;WANG Ruobing;ZHANG Yu;GUAN Zhongying(Liaoning University of Traditional Chinese Medicine,Shenyang 110000,China)

机构地区：[1]辽宁中医药大学附属第二医院,辽宁沈阳110000

出　　处：《标记免疫分析与临床》2022年第2期353-355,360,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：目的通过对6家实验室血清白蛋白的检测结果进行比对分析,探讨不同检测系统间检测结果的可比性。方法6家通过ISO15189认可的医学实验室采用相同的方法学、检测系统按校准周期进行校准、评判卫生部临床检验中心全国室间质评成绩、室内质控不精密度范围符合WS/T403-2012的要求。收集患者新鲜血分别在6家实验室的检测系统进行检测,以6家实验室数据分别与组内均值数据结果进行比对;以其他5家实验室分别与靶机实验室数据结果进行比对,进行相关回归分析,并计算医学决定水平处的系统偏差。以<1/2TE(依据WS/T403-2012)为判断标准,通过计算血清白蛋白医学决定水平处的系统偏差来判定结果的可比性。结果6家实验室与组内均值检测值比较,只有两家实验室在医学决定水平处比对通过,其他实验室均未通过。其他5家实验室与靶机实验室检测值比较,只有一家实验室在医学决定水平处比对通过,其他实验室均未通过。结论使用相同检测系统的两家实验室检测结果具有可比性;6家实验室血清白蛋白检测结果在不同检测系统中存在差异;通过对检测结果采取适宜的数字转换实现6家实验室不同检测系统间检测结果的一致性。Objective To compare and analyze the detection results of serum albumin in six laboratories to explore the comparability of the detection results among different detection systems.Methods Six medical laboratories accredited by ISO15189 adopted the same methodology,and the test system was calibrated according to the calibration cycle.The national laboratory quality assessment results of the Clinical Inspection Center of the Ministry of Health were qualified,and the inaccuracy range of indoor quality control conformed to WS/T4032012 requirements.The fresh blood of the patients was collected and tested in the testing systems of six laboratories,and the results were compared with the group mean.We compared the results of the other five laboratories with the data of the targeted laboratory,and then performed correlation regression analysis,also calculated the system deviation at the medical decision level.Taking<1/2 TE(according to WS/T403-2012)as the judgment criterion,the comparability of the results was judged by calculating the systematic deviation at the medically determined level of serum albumin.Results When compared with the mean test values of the six laboratories and the group value,only two laboratories passed at the medically determined level,and all other laboratories failed.Comparing the detection values of the other five laboratories with the targeted laboratory,only one laboratory passed at the medically determined level,and all other laboratories failed.Conclusion The test results of the two laboratories using the same test system are comparable.Test results of serum albumin in six laboratories are different with different test systems.Through the appropriate digital conversion of the test results,the consistency of the test results among different test systems in six laboratories can be achieved.

关 键 词：比对分析 可比性 医学决定水平 一致性 

分 类 号：R-331[医药卫生]