2种进口糖化清蛋白试剂的检测性能评价

Evaluation of detection performance of two imported glycosylated albumin reagents

目的评价2种进口糖化清蛋白试剂的检测性能。方法选取2020年10月空军特色医学中心收治的糖尿病患者及同期体检健康者剩余血清制备混合血清。依据北京市临床检验中心对糖化清蛋白项目的管理要求、美国临床和实验室标准协会关于清蛋白项目的管理要求,对日本旭化成制药株式会社(以下简称A)及日本积水医疗株式会社(以下简称B)的糖化清蛋白试剂进行性能评价,并通过低蛋白血症病例进行临床验证。结果2种试剂测定高低值混合样本批内精密度均<1/4北京市临床检验中心允许偏差(3.75%)。2种试剂测定北京市临床检验中心糖化清蛋白室间质评样本,A、B试剂测定值与认证值的平均偏倚<1/2允许总误差(±7.50%)。糖化氨基酸对A试剂影响在可接受范围内,对B试剂有较大影响;A、B 2种试剂检测低清蛋白血症患者样本时存在显著差异。结论2种进口糖化清蛋白试剂的精密度和正确度均可满足临床使用要求。A试剂具有较好的线性和抗干扰能力,受溶血和糖化氨基酸的影响较小,且在检测低清蛋白样本时具有性能优势。

Objective To evaluate the detection performance of two imported glycosylated albumin reagents.Methods In October 2020,the residual serum of patients with diabetes and healthy people in the same period were selected to prepare mixed serum.According to the management requirements of Beijing Clinical Laboratory Center for glycosylated albumin project and National Committee for Clinical Laboratory Standards for glycosylated albumin project,the performance of glycosylated albumin reagents from Asahi Chemical Pharmaceutical Co.,Ltd.(hereinafter referred to as A)and Shimizu Medical Co.,Ltd.(hereinafter referred to as B)was evaluated,and hypoproteinemia cases were used for clinical verification.Results The intra-assay precision of the mixed samples determined by the two reagents was<1/4 of the allowable deviation of Beijing Interim Inspection Center(3.75%).The average bias of the two reagents between the measured value and the certified value was<1/2 of the total allowable error(±7.50%).The influence of glycosylated amino acid on reagent A was within acceptable range,and the detection of reagent B affected by glycosylated amino acid was defeated.Reagent A and reagent B had significant difference in the detection of hypoproteinemia patients′specimens.Conclusion The precision and accuracy of the two imported glycosylated albumin reagents can meet the requirements of clinical application.Reagent A has good linearity and anti-interference ability,and is less affected by hemolysis and glycosylated amino acids,and has advantages in the detection of low albumin samples.