血清醛固酮候选参考测量程序的建立及性能评估  

Establishment and performance evaluation of candidate reference measurement procedure for serum aldosterone by liquid chromatography-tandem mass spectrometry

作　　者：邹继华 李全乐 沈敏 张曼[2] 杨晓东 屠敏敏 冯东方[3] 孙宏娜 ZOU Jihua;LI Quanle;SHEN Min;ZHANG Man;YANG Xiaodong;TU Minmin;FENG Dongfang;SUN Hongna(Reference Laboratory,Medical System Biotechnology Co.,Ltd.,Ningbo 315104,Zhejiang,China;Department of Clinical Laboratory,Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China;Department of Clinical Laboratory,General Hospital of Tibet Military Region,Lhasa 850007,Tibet,China)

机构地区：[1]美康生物参考实验室,浙江宁波315104 [2]首都医科大学附属北京世纪坛医院检验科,北京100038 [3]西藏军区总医院检验科,西藏拉萨850007

出　　处：《检验医学》2020年第8期811-817,共7页Laboratory Medicine

基　　金：国家重点研发计划(2019YFF0216504)。

摘　　要：目的建立基于同位素稀释液相色谱-串联质谱(ID-LC-MS/MS)的血清醛固酮候选参考方法。方法以甲基叔丁基醚为萃取剂,采用液液萃取方式进行样本前处理。以醛固酮-2H7为内标,采用电喷雾离子源(ESI)负离子模式建立检测血清醛固酮的ID-LC-MS/MS方法,并对方法的准确度、精密度、灵敏度、线性等基本分析性能进行验证。结果ID-LC-MS/MS测定血清醛固酮的线性范围为0.08~3.55 nmol/L,检测限和定量限(LOQ)分别为0.012 nmol/L和0.045 nmol/L。批内和批间变异系数(CV)分别为<5.0%和<4.1%。平均加标回收率为98.52%~100.14%。测定国际临床化学和检验医学联合会参考实验室外部质量评价计划(RELA)样本的结果偏移<1.6%。结论建立的测定血清醛固酮的ID-LC-MS/MS方法准确、精密,有望作为测定血清醛固酮的参考方法。Objective To establish a candidate reference measurement procedure for serum aldosterone by isotope dilution liquid chromatography-tandem mass spectrometry(ID-LC-MS/MS).Methods The sample was prepared by liquid-liquid extraction with methyltert-bytylether as extractant.The aldosterone-2H7 was selected as internal standard.Samples were prepared by liquid-liquid extraction,and aldosterone was detected by ID-LCMS/MS in negative ion mode.The basic analysis performance of the established candidate reference measurement procedure,including accuracy,precision,sensitivity and linearity,was evaluated.Results The linear range of aldosterone was 0.08-3.55 nmol/L.The limit of detection and the limit of quantitation were(LOQ)0.012 nmol/L and 0.045 nmol/L,respectively.The within-run coefficients of variation(CV)was<5.0%,and the between-run CV was<4.1%.The average recovery rates were 98.52%-100.14%.The bias of the International Federation of Clinical Chemistry and Laboratory Medicine External Quality Assessment Scheme for Reference Laboratories in Laboratory Medicine(RELA)was<1.6%.Conclusions The established ID-LC-MS/MS for detecting aldosterone in serum is accuracy and precise,and may be used as a candidate reference measurement procedure.

关 键 词：醛固酮 同位素稀释液相色谱-串联质谱 参考方法 

分 类 号：R446.1[医药卫生—诊断学]