糖化白蛋白和糖化血清蛋白实验室检测现状分析

Analysis of the Status of Laboratory Detection of Glycated Albumin and Glycated Serum Protein

目的调查我国临床实验室糖化白蛋白(glycated albumin,GA)和糖化血清蛋白(glycated serum protein,GSP)的检测现状,为其质量改进提供指导。方法将2022年3次室间质量评价(external quality assessment,EQA)活动中GA测定和GSP测定的实验室回报结果按试剂厂家进行分组,对实验室数≥10家的各组数据进行分析。结果2022年3次EQA活动中,GA测定依次有358、352、358家临床实验室回报了调查结果,GSP测定则依次有359、348、355家实验室回报了调查结果。按试剂厂家对回报结果分组后,实验室使用数≥10家的GA测定试剂有9种,而GSP测定试剂则有14种,其中GSP回报结果以μmol/L为单位的试剂有5种、以mmol/L为单位的试剂有9种。检测同一EQA样品时,各组GA检测结果的变异系数为1.96%~35.14%,其中位数的最大值与最小值比值为1.18~1.40;GSP的检测结果以mmol/L为单位时,各组的变异系数则为1.02%~17.30%,其中位数的最大值与最小值比值为1.44~3.08;GSP的检测结果以μmol/L为单位时,各组的变异系数为0.05%~43.48%,其中位数的最大值与最小值比值为1.28~2.95;而将GSP检测结果的单位由μmol/L转换为mmol/L时,各组中位数的最大值与最小值比值则为10.26~17.16。结论GA测定和GSP测定在不同试剂间及同一试剂不同实验室间的检测结果均存在较大差异,虽然通过EQA活动可改善实验室间检测结果的一致性,但仍急需建立GSP、GA测定的参考方法或制备具有互通性的参考物质,以帮助试剂厂家建立完整的量值溯源链,从而实现检验结果同质化和结果互认。

Objective To investigate the detection status of glycated albumin(GA)and glycated serum protein(GSP)in clinical laboratories in China,and to provide guidance for its quality improvement.Methods The return results of GA and GSP in the three external quality assessment(EQA)activities in 2022 were grouped by reagent manufacturer,and the data of each group with the number of laboratories≥10 were analyzed.Results Among the three EQA activities in 2022,358,352 and 358 clinical laboratories reported the survey results for GA assay,and 359,348 and 355 laboratories reported the survey results for GSP assay.After grouping according to the results of the reagent manufacturers,there were 9 kinds of GA determination reagents used in the laboratory≥10,while there were 14 kinds of GSP determination reagents.Among them,there were 5 kinds of reagents in the unit ofμmol/L and 9 kinds of reagents in the unit of mmol/L.When the same EQA sample was detected,the coefficient of variation of GA detection results in each group was 1.96%-35.14%,and the ratio of the maximum value to the minimum value of the median was 1.18-1.40.When the detection results of GSP were in the unit of mmol/L,the coefficient of variation of each group was 1.02%-17.30%,and the ratio of the maximum value to the minimum value was 1.44-3.08.When the detection results of GSP were in the unit ofμmol/L,the coefficient of variation of each group was 0.05%-43.48%,and the ratio of the maximum value to the minimum value of the median was 1.28-2.95.When the unit of GSP detection results was changed fromμmol/L to mmol/L,the ratio of the maximum value to the minimum value of the median in each group was 10.26-17.16.Conclusion The GA and GSP test results varied greatly between different reagents and different laboratories of the same reagent.Although the consistency of test results between laboratories can be improved through EQA activities,it is still urgent to establish a reference method for the determination of GSP and GA,or to prepare a reference material with interoperability,so as to help reagent manufacturers establish a complete quantitative traceability chain.Finally,the homogeneity of test results and mutual recognition of results are realized.