不同化学发光免疫分析设备甲功五项检测结果比对分析  

The Comparative Analysis of Thyroid Function Results from Different Chemiluminescent Immunoassay Devices

作　　者：林明[1] 靳平燕[1] 刘丽芳[1] LIN Ming;JIN Ping-yan;LIU Li-fang(People′s Hospital of Yuxi City,Yuxi 653100,China)

机构地区：[1]玉溪市人民医院核医学科

出　　处：《标记免疫分析与临床》2019年第9期1599-1602,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：目的探讨同品牌不同型号设备甲功五项(FT3、FT4、TT3、TT4、TSH)检测结果一致性及对临床诊断的影响。方法参照NCCLS文件EP9-A2方案及CLIA88化学发光总允许误差对两台不同型号化学发光设备检测结果进行一致性及临床影响评估。结果同台设备双份标本甲功五项检测结果精密度良好,未发现离群值;两台设备双份标本均值未发现离群值且相关性分析均满足EP9-A2 R^2≥0.95要求,除TT 3及TSH预计相对偏差超过了CLIA88最大允许误差(25%)的一半不能被接受,需要进行回归校正外,其余项目均在接受范围。结论同品牌不同型号化学发光免疫分析系统,部份项目结果可存在对临床诊断产生影响的差异,需引起重视。Objective To investigate the consistency and the influence on clinical diagnosis of thyroid function(FT3,FT4,TT3,TT4,TSH),by using different types of devices from the same brand.Methods We evaluated the consistency and clinical influence between two different types of devices according to total allowable deviation,which originated from the document EP9-A2 of the United States Committee for Clinical Laboratory Standardization(NCCLS)and the improve amendment regulations 1988 of the United States Clinical Laboratory(CLIA88).Results The double results of the same type device had a good precision and no outliers were observed.The results of two devices had no outliers and their correlation met the requirements of EP9-A2 with R^2≥0.95.Except for the expected relative deviation of TT 3 and TSH exceeded the half of the maximum allowable error of CLIA88 and needed to be regulated,other items were all acceptable.Conclusion Some results of different types of chemiluminescent immunoassay devices from the same brand have a difference which could influence the clinical diagnosis.

关 键 词：化学发光 免疫分析 甲功五项 结果比对 

分 类 号：R44[医药卫生—诊断学]