CLSI EP09c方案评价血气分析仪与血液分析仪检测血红蛋白和红细胞压积的一致性  

An evaluation on the consistency of blood gas analyzer and hematology analyzer in the detection of hemoglobin and hematocrit on the basis of CLSI EP09c scheme

作　　者：包晓惠 周斐斐[2] 解鸿翔[2] 章辉 徐秀湖 BAO Xiao-hui;ZHOU Fei-fei;XIE Hong-xiang;ZHANG Hui;XU Xiu-hu(不详;Department of Clinical Laboratory,Zhejiang Greentown Cardiovascular Hospital,Hangzhou,Zhejiang 310050,China)

机构地区：[1]浙江绿城心血管病医院检验科,浙江杭州310050 [2]浙江省人民医院(杭州医学院附属人民医院)检验医学中心检验中心 [3]杭州医学院检验医学院生物工程学院 [4]湖州市中医院检验科

出　　处：《中国卫生检验杂志》2023年第17期2099-2103,共5页Chinese Journal of Health Laboratory Technology

基　　金：浙江省教育厅一般科研项目(Y202146133);浙江省中医药科技计划项目(2023ZL009)。

摘　　要：目的 参照CLSI EP09c文件,比较2种不同检测原理的血气分析仪ABL800 Flex、GEM3500测量的血红蛋白(Hb)和红细胞压积(Hct)与XN-9000血液分析仪检测结果的一致性。方法 采用回顾性分析,收集ABL800 Flex与XN-9000患者配对数据379对,GEM3500配对数据448对,计算组内相关系数。选取最佳回归模型进行拟合,计算各参数在相应医学决定水平处的偏倚,Bland-Altman图分析平均偏倚。结果 ABL800 Flex与XN-9000的Hb和Hct配对数据组内相关系数分别为0.989 8、0.982 3,GEM3500分别为0.881 2和0.927 4,均为高度相关。与XN-9000相比,ABL800 Flex的Hb检测结果在医学决定水平45、105、170、230处的相对偏倚分别为-2.93%、-2.82%、-2.79%、-2.78%,平均相对偏倚为-2.9%;Hct在医学决定水平0.14、0.33、0.56、0.70处的相对偏倚分别为-1.00%、0.01%、0.31%、0.40%,平均相对偏倚为-0.02%。GEM3500的Hb检测结果在45、105、170、230处的相对偏倚分别为11.55%、-6.32%、-12.09%、-14.62%,平均相对偏倚为-9.2%;Hct在0.14、0.33、0.56、0.70处的相对偏倚分别为11.61%、-2.52%、-7.23%、-8.62%,平均相对偏倚为-4.3%。结论 ABL800 Flex与XN-9000的Hb和Hct检测结果具有良好的一致性,可以互换使用。GEM3500和XN-9000之间没有足够的可比性,应建立自己的参考范围。检测原理可能是影响血气分析仪与血液分析仪一致性的重要因素。Objective This paper aims to compare the consistency of hemoglobin(Hb) and hematology(Hct) measured by 2 blood gas analyzers with different testing principles, ABL800 Flex and GEM3500, with the results of the same items measured by XN-9000 hematology analyzer according to the CLSI EP<09c scheme. Methods Retrospective analysis was used to collect 379 paired patient data of ABL800 Flex and XN-9000, and 448 paired data of GEM3500 and XN-9000, and the intragroup correlation coefficient was calculated. The best regression model was selected, and the bias of each parameter at the corresponding medical decision level was calculated. The average bias was analyzed by Bland-Altman. Results The intra-group correlation coefficients of Hb and Hct paired data were 0.989 8 and 0.982 3 for ABL800 Flex and XN-9000, respectively, and 0.881 2 and 0.927 4 for GEM3500, respectively, both of which were highly correlated. Compared with XN-9000 hematology analyzer, the relative bias of Hb measured by ABL800 Flex blood gas analyzer at the medically determined level(45, 105, 170, 230) were-2.93%,-2.82%,-2.79%,-2.78%, with an average relative bias of-2.9%. The relative bias of Hct at the medical decision level(0.14, 0.33, 0.56, 0.70) were-1.00%, 0.01%, 0.31%, 0.40%, respectively, with an average relative bias of-0.02%. The relative bias of Hb measured by GEM3500 blood gas analyzer at the medically determined level(45, 105, 170, 230) were 11.55%,-6.32%,-12.09%,-14.62%, with an average relative bias of-9.2%.The relative bias of Hct at the medical decision level(0.14, 0.33, 0.56, 0.70) were 11.61%,-2.52%,-7.23%,-8.62%, respectively, with an average relative bias of-4.3%. Conclusion The results of Hb and Hct measured by ABL800 Flex blood gas analyzer have good consistency with the results of XN-9000 blood analyzer, and can be used interchangeably. There is insufficient comparability between the GEM3500 blood gas analyzer and the XN-9000 blood analyzer, and your own reference range should be established. The principle of detection may be an imp

关 键 词：血气分析仪 血液分析仪 血红蛋白 红细胞压积 方法学比对 CLSI EP09c 

分 类 号：R446.11[医药卫生—诊断学]