酶放大免疫法与荧光免疫层析法检测万古霉素血液浓度的对比研究  

Comparison of Enzyme-multiplied Immunoassay and Fluorescence Immunochromatography in the Detecting Blood Concentrations of Vancomycin

作　　者：师亚玲 丰航[1] 廉江平[1] 张鹏[1] 李黎[1] SHI Ya-ling;FENG Hang;LIAN Jiang-ping;ZHANG Peng;LI Li(Department of Pharmacy,Shaanxi Provincial People’s Hospital,Xi’an 710068,China)

机构地区：[1]陕西省人民医院药学部,西安710068

出　　处：《现代检验医学杂志》2022年第1期168-171,共4页Journal of Modern Laboratory Medicine

摘　　要：目的比较酶放大免疫法(enzyme-multiplied immunoassay technique,EMIT)和荧光免疫层析法(fluorescence immunochromatography assay,FICA)测定万古霉素血液浓度的结果及相关性分析。方法收集2020年9月~11月需要进行万古霉素血液浓度检测的样本121例,分别采用EMIT法和FICA法测定万古霉素血液浓度,使用SPSS18.0进行配对t检验及Pearson相关性分析,采用Bland-Altman分析测定结果的一致性。结果EMIT法测定回收率在99.8%~106.4%之间,FICA测定回收率在98.4%~107.2%之间,两种方法日间和日内精密度均<20%,均符合生物样品检定要求。EMIT法测定121个样品结果均值为18.83±11.24μg/ml,FICA法检测结果均值为18.16±9.67μg/ml。配对样本的t检验结果表明,两种方法检测结果差异无统计学意义(t=1.584,P=0.117)。Pearson分析相关系数为r=0.946(P<0.05),Bland-Altman图有115个数据在一致性界限内(95.0%),表明两种检测方法有良好的相关性和一致性。结论EMIT法测定万古霉素血液浓度较FICA法偏高,两种方法所得结果间具有相关性和一致性。两种方法均为有效可靠的万古霉素血液浓度监测方法,在临床选择测定方法时,应综合考虑样本、实验室条件、人员配置等因素。Objective To compare the results of enzyme-multiplied immunoassay technique(EMIT)and fluorescence immunochromatography assay(FICA)for quantitative determination of vancomycin concentrations in serum.Method 121 blood samples were collected from September 2020 to November 2020 for determination of vancomycin concentrations by the EMIT and FICA respectively.SPSS18.0 was used for t test and correlation analysis,and Bland-Altman plot was used for the consistency analysis.Results The recoveries of EMIT method and FICA were 99.8%~106.4%and 98.4%~107.2%respectively.The precision of the two methods were less than 20%,and both of them met the requirements of biological sample verification.The mean value of 121 samples determined by EMIT method was 18.83±11.24μg/ml,and the mean value of FICA was 18.16±9.67μg/ml.The results of paired t test showed that there was no statistical difference between the two methods(t=1.584,P=0.117).The correlation coefficient of Pearson analysis was r=0.946(P<0.05),and 115 data of Bland-Altman plot were within the consistency limit(95.0%),indicating that the two detection methods had good correlation and consistency.Conclusion Blood concentration of vancomycin determined by EMIT method was higher than that by FICA.EMIT and FICA assay are both effective and reliable methods for vancomycin concentration monitoring.The samples,laboratory conditions,personnel allocation and other factors should be taken into account when selecting the determination method in clinical practice.

关 键 词：酶放大免疫法 荧光免疫层析法 万古霉素 血液浓度 

分 类 号：Q503[生物学—生物化学] R978.1[医药卫生—药品]