血清(浆)类固醇激素液相色谱-串联质谱检测质量保证专家共识

Expert consensus on quality assurance of serum (plasma) steroid hormones measurements by liquid chromatography-tandem mass spectrometry

液相色谱-串联质谱(LC-MS/MS)在人体血清(浆)类固醇激素检测中展现出优于传统免疫学方法的特异性高、分析测量范围宽、多标志物同时检测等特点, 已成为国际内分泌学领域相关疾病实验室诊断的首选方法。目前, 国内医学实验室开展血清(浆)类固醇激素LC-MS/MS检测多参考已发表学术论文和仪器厂家说明书提供的通用操作和检测程序。然而, 血清(浆)类固醇激素LC-MS/MS检测的技术难度大, 临床实验室检验人员大多数缺少质谱领域专业培训和实践经验, 而通用程序缺乏针对性和实操性, 尤其我国尚无针对该检测程序和质量保证的系统性文件, 导致实验室间检测结果存在较大差异, 阻碍了该技术的临床应用。为规范我国血清(浆)类固醇激素LC-MS/MS检测, 共识从检验前、中、后程序及其质量保证进行详细说明, 并提出针对性建议, 为实验室开展该检测项目提供参考, 以推动我国血清(浆)类固醇激素LC-MS/MS检测的临床应用和结果一致性。

Liquid chromatography-tandem mass spectrometry(LC-MS/MS)method for measuring serum(plasma)steroid hormones has shown advanced characteristics including high specificity,wide analytical measurement range and simultaneous analysis for multiple markers,compared with traditional immunoassays,which has become the preferred method applied in lab diagnosis of endocrinological diseases.Currently,measurement of serum/plasma steroid hormones by LC-MS/MS in our national lab mainly refer to the general operation and testing procedures guided by academic publications or general operation manuals of the instruments.However,there are great difficulties in measurement of serum/plasma steroid hormones by LC-MS/MS method,and most lab staffs lack of professional training and practical experience in mass spectrometry,and the general procedures lack specificity and practical operation,especially there is no specific systemic documents covering testing procedures and quality assurance,consequently,testing results vary considerably between laboratories,hindering its clinical application.In order to normalize our national serum/plasma steroid hormones by LC-MS/MS,this consensus aims to provide detailed information and specific suggestions for pre-analytical,analytical,post-analytical and quality assuarance,and to provide reference for the application of LC-MS/MS in medical laboratories for serum/plasma steroid hormone measurements,in order to improve consistency of serum/plasma steroid hormone measurements with LC-MS/MS and promote its clinical application in China.