自动化磁珠法提取血清睾酮应用液相色谱串联质谱法检测的性能评价  

Performance Evaluation of Automatic Magnetic Bead Extraction of Serum Testosterone by Liquid Chromatography-tandem Mass Spectrometry

作　　者：李莉 黄亚玲 LI Li;HUANG Yaling(Department of Clinical Laboratory,the People’s Hospital of Kaizhou District,CQ,Chongqing 405400,China;Department of Medical Laboratory,People’s Hospital Affiliated to Chongqing Three Gorges Medical College,Chongqing 404100,China)

机构地区：[1]重庆市开州区人民医院检验科,重庆405400 [2]重庆三峡医药高等专科学校附属人民医院医学检验科,重庆404100

出　　处：《现代检验医学杂志》2024年第4期180-185,共6页Journal of Modern Laboratory Medicine

基　　金：重庆市卫生健康委医学科研项目(2021WSJK126)。

摘　　要：目的建立自动化磁珠标本制备法(automated magnetic specimen preparation,MSPE)提取联合液相色谱串联质谱(liquid chromatography-tandem mass spectrometry,LC-MS/MS)检测人血清中睾酮(testosterone,T)方法并评估其性能。方法选取2023年4~6月在重庆市开州区人民医院就诊的150例患者作为研究对象,采用MSPE联合LCMS/MS方法检测患者的血清睾酮,排除患者血清溶血、乳糜、黄疸等异常,评价该方法的特异度、线性、定量限、回收率、精密度及基质效应。同时比较化学发光免疫法(chemiluminescence immunoassay,CLIA)与MSPE联合LC-MS/MS检测两种方法结果的一致性。结果MSPE联合LC-MS/MS方法检测睾酮的检测限为0.005 ng/ml,定量限为0.05 ng/ml,该方法在0.05~15 ng/ml范围内相关性良好,r^(2)>0.99;批内、批间、总精密度均小于15%;回收率为105.5%~106.2%;血清内标与分析物的基质效应接近;与CLIA方法比较,两种方法检测结果相关性较好(r=0.9971),相对百分偏差小于15%。结论MSPE提取联合LC-MS/MS检测人血清中睾酮性能良好,能够满足人血清样品中睾酮的定量分析需求。Objective To establish an automated magnetic specimen preparation(MSPE)extraction combined with liquid chromatography tandem mass spectrometry(LC-MS/MS)in the detection of testosterone(T)in human serum,and evaluate its performance.Methods A total of 150 patients treated in Kaizhou District People’s Hospital of Chongqing from April to June 2023 were selected as the study objects.MSPE combined with LC-MS/MS method was used to detect the serum testosterone of the patients.Excluding the abnormalities of serum hemolysis,chylus and jaundice,the specificity,linearity,limit of quantification,recovery rate,precision and matrix effect of the method were evaluated.The results of chemiluminescence immunoassay(CLIA)and MSPE combined with LC-MS/MS were compared.Results The detection limit and quantitation limit of MSPE combined with LC-MS/MS method for the detection of testosterone were 0.005 ng/ml and 0.05 ng/ml,respectively,and the correlation was good in the range of 0.05~15 ng/ml with r^(2)>0.99.Intra-lot,inter-lot and total precision were less than 15%.The recovery rate was 105.5%~106.2%.The matrix effect of serum internal standard was close to that of analyte.Compared with CLIA method,the correlation between the two methods was better(r=0.9971),and the relative percentage deviation was less than 15%.Conclusion The combination of MSPE extraction and LC-MS/MS detection of testosterone in human serum has good performance,which can meet the quantitative analysis requirements of testosterone in human serum samples.

关 键 词：自动化磁珠法 液相色谱串联质谱法 血清睾酮 

分 类 号：Q503[生物学—生物化学]