上海地区临床实验室液相色谱串联质谱技术应用现状分析  

Current status of liquid chromatography-tandem mass spectrometry in clinical laboratories in Shanghai

作　　者：方慧玲 居漪 欧元祝 朱宇清 李卿 金中淦 赵晓君 范霄宇 虞科颖 FANG Huiling;JU Yi;OU Yuanzhu;ZHU Yuqing;LI Qing;JIN Zhonggan;ZHAO Xiaojun;FAN Xiaoyu;YU Keying(Shanghai Center for Clinical Laboratory,Shanghai 200126,China)

机构地区：[1]上海市临床检验中心,上海200126

出　　处：《检验医学》2024年第9期853-858,共6页Laboratory Medicine

基　　金：上海市临床检验中心自选课题(2023ZXKT-01)。

摘　　要：目的 了解液相色谱串联质谱(LC-MS/MS)技术在上海地区临床实验室的应用现状。方法 采用自行设计的调查问卷对上海地区开展临床质谱检测的实验室进行调查,分析各实验室的专业人员、仪器设备、项目开展和运行情况。结果 上海地区共有17家医疗机构的实验室开展LC-MS/MS检测工作,其中三级医院16家,二级医院1家;综合性医院14家,专科医院3家。实验室相关技术人员主要为医学检验专业人员,有69.6%的人员从事质谱检测的工作年限为1~5年,中级职称人员为54.3%。17家实验室中有16家每年校准质谱仪器1~2次,有15家每年进行1~2次维护保养。有82.4%的实验室所使用的质谱仪年故障次数为1~3次,配套的液相色谱系统年故障次数为1~5次。有3家实验室开展的LC-MS/MS项目数分别达到66、84和100项,其他实验室开展的项目数均≤33项,检测项目集中于维生素、内分泌激素和药物浓度监测(TDM)等。所有实验室均按要求开展室内质控,使用的质控品多为商品化质控品;在激素、维生素、抗菌药物TDM项目中,分别有42.9%、25.0%和50.0%的实验室使用自制质控品进行室内质控。有1家实验室使用Westgard西格玛规则进行室内质控分析,其他实验室选择Westgard多规则质控程序。对于有室间质评计划的项目,各实验室均通过参加室间质评完成实验室间的结果比对。对于无室间质评计划的项目,各实验室定期开展实验室间比对工作。结论 LC-MS/MS技术在上海地区的应用尚处于起步阶段,需要加强专业技术人员培训,完善质量保障措施,以提升临床应用中的检测质量。Objective To investigate the application status of liquid chromatography-tandem mass spectrometry(LC-MS/MS)in clinical laboratories in Shanghai.Methods The self-built questionnaire was used to investigate the clinical mass spectrometry laboratories in Shanghai,and the professional staff,equipment,project development and operation status was analyzed.Results LC-MS/MS was performed in 17 medical institutions in Shanghai,including 16 Grade 3 hospitals and 1 Grade 2 hospital.There were 14 general hospitals and 3 specialized hospitals.Laboratoryrelated technical personnel were mainly medical laboratory professionals,69.6%engaged in mass spectrometry for 1 to 5 years,54.3%of moderate level of professional titles.The 16 of 17 laboratories calibrated mass spectrometer once or twice a year,and 15 laboratories performed maintenance once or twice a year.The 82.4%of mass spectrometers used had an annual failure frequency of 1 to 3 times,and the supporting liquid chromatography system had an annual failure frequency of 1 to 5 times.The number of liquid chromatography-tandem mass spectrometry projects carried out by 3 laboratories reached 66,84 and 100,respectively,the number carried out by the other laboratories was≤33,and the determination projects focused on vitamins,endocrine hormones and therapeutic drug monitoring(TDM).All the laboratories carried out internal quality control according to the requirements,and the quality control materials used were mostly commercial quality control materials.In the TDM projects of hormones,vitamins and antibiotics,42.9%,25.0% and 50.0% of laboratories used homemade quality control materials for internal quality control.One laboratory used the Westgard sigma rule for internal quality control analysis,and the other laboratories chosethe Westgard multi-rule quality control procedure. For projects with an inter-laboratory quality assessment,eachlaboratory completed the result comparison in the inter-laboratory quality assessment. For projects without an interlaboratoryquality assessment,la

关 键 词：液相色谱串联质谱 临床实验室 应用现状 

分 类 号：R446.1[医药卫生—诊断学]