基于高效液相色谱串联质谱技术建立上海地区健康成人血浆氨基酸谱的参考区间  

Establishment of reference intervals of plasma aminogram of healthy adults in Shanghai area based on high-performance liquid chromatography-tandem mass spectrometry technique

作　　者：朱璇 詹盈盈 赵阳阳 胡尧 张翠萍 ZHU Xuan;ZHAN Yingying;ZHAO Yangyang;HU Yao;ZHANG Cuiping(Department of Laboratory Medicine,the Second Affiliated Hospital of Guangxi Medical University,Nanning 530007,China;CALIBRA Scientific,Inc.,Hangzhou 310030,China;Department of Laboratory Medicine,Traditional Chinese Medicine Hospital of Qingpu District of Shanghai,Shanghai 201799,China;Department of Laboratory Medicine,Huashan Hospital Affiliated to Fudan University,Shanghai 200040,China)

机构地区：[1]广西医科大学第二附属医院医学检验科,南宁530007 [2]凯莱谱科技股份有限公司,杭州310030 [3]上海市青浦区中医医院检验科,上海201799 [4]复旦大学附属华山医院检验医学科,上海200040

出　　处：《中国临床新医学》2025年第2期159-168,共10页CHINESE JOURNAL OF NEW CLINICAL MEDICINE

基　　金：国家自然科学基金项目(编号:82002247);上海市卫生健康委员会临床研究专项课题(编号:20204Y0426)。

摘　　要：目的基于高效液相色谱串联质谱(HPLC-MS/MS)技术建立上海地区健康成人血浆氨基酸谱的参考区间并进行验证。方法招募2023年1月至10月于复旦大学附属华山医院体检中心进行健康体检的表观健康者341名。另于2023年11月至12月招募表观健康者40名用于参考区间验证。应用HPLC-MS/MS技术对研究对象进行28种血浆氨基酸水平检测,建立上海地区健康成人血浆氨基酸谱的参考区间,并对参考区间进行验证。结果HPLC-MS/MS检测成人血浆氨基酸的方法学评价结果显示,分析物精密度变异系数<15%,准确度为86%~115%,定量下限偏差<15%,变异系数<15%,线性范围标准曲线相关系数R^(2)>0.99,携带污染率和样本稳定性验证均符合相应要求。基于该检测方法建立了上海地区健康成人28种血浆氨基酸的参考区间。性别分层分析结果显示,健康成年男性血浆中大多数氨基酸及代谢物水平高于女性,差异有统计学意义(P<0.05)。验证结果显示,该研究建立的参考区间符合《临床实验室检验项目参考区间的制定》(WS/T 402—2012)标准要求。结论该研究建立并验证了上海地区健康成人的28种血浆氨基酸的参考区间,为临床诊疗提供依据。Objective To establish and validate the reference intervals of plasma aminogram of healthy adults in Shanghai area based on high-performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS)technique.Methods A total of 341 apparently healthy individuals who underwent physical examination at the Physical Examination Center of Huashan Hospital Affiliated to Fudan University from January 2023 to October 2023 were recruited.Other 40 apparently healthy individuals were recruited from November 2023 to December 2023 for reference interval validation.HPLC-MS/MS technique was used to detect the levels of 28 kinds of amino acids in the plasma of the study subjects.The reference intervals of plasma aminogram of healthy adults in Shanghai area were established and validated.Results The methodological evaluation results of HPLC-MS/MS detection of adult plasma amino acids showed that the coefficient of variation of precision of the analytes was less than 15%,and the accuracy was between 86%and 115%,and the quantification lower limit deviation was less than 15%,and the coefficient of variation was less than 15%.The correlation coefficient(R^(2))of the linear range standard curve was greater than 0.99,and the validations of the carrying contamination rate and sample stability met the corresponding requirements.Based on this method,the reference intervals of 28 kinds of amino acids in the plasma of healthy adults in Shanghai area were established.The results of gender stratification analysis showed that the levels of most amino acids and metabolites in the plasma of healthy adult males were higher than those in the plasma of healthy adult females,and the differences were statistically significant(P<0.05).The validation results showed that the reference intervals established in this study met the requirements of Define and Determine the Reference Intervals in Clinical Laboratory(WS/T 402—2012)standard.Conclusion In this study,the reference intervals of 28 kinds of plasma amino acids in healthy adults in Shanghai area ar

关 键 词：高效液相色谱串联质谱 氨基酸 性能验证 参考区间 

分 类 号：R446.1[医药卫生—诊断学]