CLSI EP9-A3对顶空气相色谱法与干化学比色法检测血液酒精含量的可比性分析  

Comparability Analysis of CLSI EP9-A3 on Headspace Gas Chromatography and Dry Chemical Colorimetry for Determination of Blood Alcohol Content

作　　者：田欢[1] 程丰 张剑波 龚国富 刘敏 TIAN Huan;CHENG Feng;ZHANG Jian-bo;GONG Guo-fu;LIU Min(Department of Laboratory,Ezhou Central Hospital,Ezhou 436000,Hubei,China;Department of Quality Management,Ezhou Central Blood Station,Ezhou 436000,Hubei,China)

机构地区：[1]湖北省鄂州市中心医院检验科,湖北鄂州436000 [2]湖北省鄂州市中心血站质量管理科,湖北鄂州436000

出　　处：《医学信息》2021年第19期165-168,共4页Journal of Medical Information

摘　　要：目的分析血液酒精含量的检测结果在不同方法间的可比性。方法参照美国临床和实验室标准化协会EP-A3文件进行方法学比对和偏倚评估,用顶空气相色谱法与干化学比色法分别测定40份血液样本的酒精含量,通过广义极端学生化偏差(ESD)法检验离群值点,选用最佳回归模型拟合回归方程,并计算酒精含量阈值处的偏倚。结果在散点图中未见异常值点,ESD法检验未发现离群值点;顶空气相色谱法与干化学比色法检测结果相关性良好(r2>0.95);差值具有恒定CV变化,采用加权最小二乘法(WLS)回归分析,在血液酒精含量阈值处(20、80 mg/dl),偏倚分别为-2.84%、-1.77%,均小于5%可接受标准。结论干化学比色法测定血液酒精含量的偏倚可接受,顶空气相色谱法与干化学比色法测定血液酒精含量的结果具有可比性。Objective To analyze the comparability of blood alcohol test results between different methods.Methods EP-A3 with reference to the clinical and laboratory standards institute file for methodology,comparison and bias evaluation by headspace gas chromatography method with dry chemical colorimetry respectively through determination of 40 samples of blood alcohol content,the generalized extreme deviation(ESD)to test the students outlier points,choose the best regression model fitting regression equation,and calculate the alcohol content of threshold bias.Results No abnormal value points were found in the scatter diagram,and no outliers were found in ESD test.The correlation between headspace gas chromatography and dry chemical colouring was good(r2>0.95).The differences presented constant CV changes and were analyzed by weighted least squares(WLS)regression analysis,the results showed that at the blood alcohol content thresholds(20,80 mg/dl),the bias was-2.84%and-1.77%,which were all less than 5%acceptable standard.Conclusion The bias of dry chemical colorimetry is acceptable,and the results of headspace gas chromatography and dry chemical colorimetry are comparable.

关 键 词：血液酒精含量 EP9-A3 顶空气相色谱法 干化学比色法 

分 类 号：R446[医药卫生—诊断学]