博唐平®A1C EZ 2.0糖化血红蛋白床旁检测仪的临床应用效果评估  

Clinical Application Effect Evaluation of Botangping®A1C EZ 2.0 Glycosylated Hemoglobin Bedside Detector

作　　者：娄瑞可 文玉琼[1] 蓝颖茹[1] 姚海艳[1] 胡文慧 刘良珊 Lou Rui-ke;Wen Yu-qiong;Lan Ying-ru;Yao Hai-yan;Hu Wen-hui;Liu Liang-shan(Department of Endocrinology,Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences),Guangzhou 510080,Guangdong Province,China)

机构地区：[1]广东省人民医院(广东省医学科学院)内分泌科,广东广州510080

出　　处：《中国社区医师》2022年第30期100-102,共3页Chinese Community Doctors

基　　金：2020年广东省人民医院登峰计划(护理科研项目);糖尿病慢性并发症模拟体验教育的效果研究(DFJH2020008)。

摘　　要：目的:对博唐平®A1C EZ 2.0糖化血红蛋白(HbA1c)床旁检测仪的临床性能进行评估。方法:选取2020年4-8月广东省人民医院收治的100例糖尿病患者为研究对象,将实验室仪器设为参考系统,博唐平®A1C EZ 2.0设为评估系统,对两款仪器检测HbA1c的结果进行Passing-Bablok回归分析、Bland-Altman分析、偏差分析。结果:博唐平®A1C EZ 2.0指尖末梢血组与博唐平®A1C EZ 2.0静脉血组比较,再与实验室静脉血组比较,结果均呈线性相关(r=0.946);博唐平®A1C EZ 2.0所测结果均值与实验室Bio-RadD-10 HbA1c测定仪所测结果均值比较,平均相对偏差为0.2%,95%CI内相对偏差为-1.7%~2.1%,仅有6.00%(6/100)界外点数。结论:博唐平®A1C EZ 2.0能够满足HbA1c临床检测的应用要求,适用于临床糖尿病管理。Objective:To evaluate the clinical performance of Botangping®A1C EZ 2.0 glycosylated hemoglobin(HbA1c)bedside detector.Methods:A total of 100 patients with diabetes who were admitted to Guangdong Provincial People's Hospital from April 2020 to August 2020 were selected as the study subjects.The laboratory instruments were set as reference system,Botangping®A1C EZ 2.0 was set as the evaluation system.The detection results of HbA1c by two instruments were subject to Passing-Bablok regression analysis,Bland-Altman analysis and deviation analysis.Results:Botangping®A1C EZ 2.0 fingertip peripheral blood group was compared to Botangping®A1C EZ 2.0 venous blood group and laboratory venous blood group,the results showed a linear correlation(r=0.946);the mean detection results of Botangping®A1C EZ 2.0 were compared to those of laboratory Bio-Rad D-10 HbA1c detector,the average relative deviation was 0.2%.Within the 95%CI,the relative deviation was-1.7%to 2.1%,and there were only 6/100(6.00%)points out of bounds.Conclusion:Botangping®A1C EZ 2.0 can meet the application requirement of clinical HbA1c detection and is applicable for clinical management of diabetes.

关 键 词：博唐平®A1C EZ 2.0 糖化血红蛋白 床旁检测 临床评估 

分 类 号：R587.1[医药卫生—内分泌] R446.1[医药卫生—内科学]