CLSI EP09c方案评价ICU患者动脉导管采血进行生化项目检测的可行性  

Feasibility of CLSI EP09c protocol to evaluate arterial catheter blood collection for biochemical tests in ICU patients

作　　者：吴高平 庞珍珍[2] 张玉霞[2] 解鸿翔[2] 章辉 蔡谦谦 WU Gao-ping;PANG Zhen-zhen;ZHANG Yu-xia;XIE Hong-xiang;ZHANG Hui;CAI Qian-qian(Hangzhou Adicon Medical Laboratory Co.,Ltd.,Zhejiang 310030,China)

机构地区：[1]杭州艾迪康医学检验中心有限公司,浙江310030 [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]上海交通大学医学院附属第一人民医院普外科

出　　处：《中国卫生检验杂志》2023年第11期1289-1295,共7页Chinese Journal of Health Laboratory Technology

基　　金：浙江省医药卫生科技计划项目(2021KY017,2022K Y 027);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);2022年浙江省高校基本科研经费专项资助(KYYB202216)。

摘　　要：目的参照CLSI EP09c文件,探讨ICU患者动脉导管采集的血标本与静脉血之间电解质、代谢产物、蛋白质和酶等18项常见生化项目检测结果是否存在差异。方法采用自身配对设计,本院75例ICU患者动脉导管采血进行常见生化项目检测,同时采集相应的静脉血检测作为参照值。Passing-Bablok回归分析各参数在相应医学决定水平处的偏倚,使用卫生行业标准的1/2允许总误差(allowable total error,TEa)作为可接受标准。对于偏倚具有临床意义的项目,采用Bland-Altman分析计算2种标本类型的平均偏倚。结果除K、TP、ALB外,动脉导管采集的标本血清中Na、Cl、Ca、Urea、Crea、Uric、Glu、TBIL、CHOL、TG、HDL-c、AST、ALT、GGT、ALP等15项生化项目检测结果与相应静脉血血清的检测结果在各自医学决定水平处的偏倚均小于1/2TEa,偏倚无临床意义。与静脉血相比,动脉血K在医学决定水平(3,5.8,7.5)处的相对偏倚分别为-4.08%、-2.09%、-1.61%,平均偏倚为-0.11 mmol/L(95%CI:-0.16~-0.06,95%LoA:-0.52~0.30);TP在医学决定水平(45.0,60.0,80.0)处的相对偏倚分别为-3.4%、-2.9%、-2.6%,平均偏倚为-1.7 g/L(95%CI:-2.1~-1.3,95%LoA:-5.1~1.8);ALB在医学决定水平(20.0,35.0,52.0)处的相对偏倚分别为-3.3%、-2.1%、-1.5%,平均偏倚为-0.8 g/L(95%CI:-1.0~-0.5,95%LoA:-2.8~1.3)。结论ICU患者在使用动脉导管采血进行生化项目检测时,K、TP、ALB检测结果与静脉血检测结果之间的差异具有临床意义,不可互换使用,必要时应建立相应的参考区间。Objective Referring to the CLSI EP09c protocol,this paper aims to explore the differences in the detection results of 18 common biochemical items such as electrolytes,metabolites,proteins and enzymes between blood samples collected from arterial catheters and venous blood in ICU patients.Methods Using self-matching design,arterial catheter blood samples were collected from 75 ICU patients in our hospital for common biochemical tests,and corresponding venous blood tests were collected as reference values.Pass-Bablok regression was used to analyze the bias of each parameter at the corresponding medical decision level,using the allowable total error(TEa)of the health industry standard as the acceptable standard.For items with clinical significance of bias,Bland-Altman analysis was used to calculate the average bias of the two specimen types.Results Except K,TP and ALB,the test results of serum Na,Cl,Ca,Urea,Crea,Uric,Glu,TBIL,CHOL,TG,HDL-c,AST,ALT,GGT,and ALP of the 15 biochemical items yielded a bias of less than 1/2TEa at their medical decision levels between in the samples collected by arterial catheters and in the samples collected by venous catheters.Bias has no clinical significance.Compared with venous blood,the relative bias of arterial blood K at the medically determined levels(3,5.8,7.5)was-4.08%,-2.09%,and-1.61%,respectively,with an average bias of-0.11 mmol/L(95%CI:-0.16--0.06,95%LoA:-0.52-0.30).The relative bias of TP at the medical determination level(45.0,60.0,80.0)was-3.4%,-2.9%,and-2.6%,respectively,and the mean bias was-1.7 g/L(95%CI:-2.1--1.3,95%LoA:-5.1-1.8).The rela⁃tive bias of ALB at the medical determination level(20.0,35.0,52.0)was-3.3%,-2.1%,-1.5%,respectively,and the mean bias was-0.8 g/L(95%CI:-1.0--0.5,95%LoA:-2.8-1.3).Conclusion When using arterial catheter blood collection for biochemical tests in ICU patients,the differences between K,TP,ALB test results and venous blood test results are clinically significant and should not be used interchangeably.Corresponding reference intervals

关 键 词：动脉导管 静脉血 生化项目 可比性验证 EP09c 

分 类 号：R446.11[医药卫生—诊断学]