The establishment of a method for serum glycated albumin based on liquid chromatography/tandem mass spectrometry / 中华检验医学杂志

ABSTRACT

Objective To establish a candidate reference method for determination of serum glycated albumin based on isotope dilution liquid chromatography /tandem mass spectrometry(ID-LC/MS). Methods Establishment of a method.According to the Japan Society of Clinical Chemistry(JSCC) reference method,the serum albumin was firstly purified by SDS-PAGE and decomposed into amino acid fragments.It selected 2H and 13C respectively as internal standards of lysine and DOF-lysine and chose the lysine and DOF-Lysine as standard material.Then the lysine and DOF-lysine were determined according to peak area after the optimization of analysis conditions.The validity of reference method was verified by the glycated albumin standard material JCCRM611-1 of Japan check medical material institutions.The evaluation of precision depended on the determination of three different concentrations of mixed serum samples for three days.The patients'serum(35 specimens)were determined by this method and a routine test method, and then the correlation of measured value was confirmed.Results The total CV of JCCRM611-1 reference material were 3.2%,2.3% and 2.6%, which had the bias of +2.25%, +2.38%, -1.21% by the deviation values.The intra CV was 0.33%-2.53%,CV for between -run assays was 0.83%-1.32%,total CV ranged from 2.27% to 3.2%.Correlation coefficient of the mass spectrometry and routine enzymatic method is 0.993.Conclusions The ID-LC/MS method for the measurement of serum glycated albumin is precise and accurate.In addition,this method showed great correlation with routine enzymatic method.It can be proposed as a candidate reference method for the determination of serum glycated albumin in China.