采用葡萄糖参考方法为室间质量评价样本确定靶值的应用初探

Preliminary study on the application of glucose reference method to determine the target value for EQA samples

目的探讨运用葡萄糖(Glu)参考方法为室间质量评价(EQA)样本确定靶值的可行性。方法利用上海市临床检验中心参考测量实验室已建立的国际检验医学溯源联合委员会(JCTLM)推荐的同位素稀释气相色谱串联质谱参考方法,测定2018年上海地区第2次EQA样本Glu的含量,并以其为靶值,对参评实验室反馈结果进行统计分析。结果2018年第2次EQA有509家参评实验室以实验室检测结果中位值为靶值、允许总误差的7%为标准评价,EQA 1~5样本的不合格率分别为2.16%、2.95%、3.34%、3.14%、1.77%;若以参考方法定值结果为靶值,则不合格率分别为2.75%、3.14%、2.75%、7.86%、2.16%。结论质量评价机构应关注EQA样本的质量,临床实验室应重视低浓度下Glu测量的可靠性。

Objective To investigate the feasibility of using glucose(Glu)reference method to determine the target value for external quality assessment(EQA)samples.Methods The value of Glu was assigned to the samples of EQA in Shanghai using isotope dilution gas chromatography tandem mass spectrometry(ID-GC/MS)which was recommended by the Joint Committee for Traceability in Laboratory Medicine(JCTLM).The data was used as the target value for statistical analysis of the feedback results of participating laboratories in the 2nd EQA of 2018.Results The data of the 2nd EQA was from 509 laboratories in 2018.When the target value was average from all laboratories,setting 7%as allowable total error,the failure rates of EQA samples were 2.16%,2.95%,3.34%,3.14%and 1.77%,respectively.However,the failure rates were 2.75%,3.14%,2.75%,7.86%and 2.16%,respectively,using the value assigned by reference method as target value.Conclusions The quality assessment institutions should pay attention to the quality of EQA samples,and clinical laboratories should pay attention to the reliability of Glu measurement at low concentration.