六种糖化白蛋白酶法试剂的性能验证  

Performance verification of six enzymatic glycated albumin reagents

作　　者：尹逸丛 赵芳[1] 侯立安[1] 禹松林[1] 李洪雷[1] 国秀芝[1] 吴洁[1] 由婷婷[1] 程歆琦[1] 程倩[1] 邱玲[1] 

机构地区：[1]中国医学科学院北京协和医学院、北京协和医院检验科,100730

出　　处：《中华检验医学杂志》2017年第6期436-442,共7页Chinese Journal of Laboratory Medicine

基　　金：国家科技支撑计划（2015BAI32H00）;首都卫生发展科研专题项目（首发2016-2-4017）

摘　　要：目的对六种糖化白蛋白（GA）酶法试剂进行性能验证，评价其临床应用价值。方法在OlympusAU5800全自动生化分析仪上对北京九强、北京利德曼、宁波美康、北京豪迈、四川迈克、日本旭化成的GA酶法试剂（标为A、B、C、D、E、F）进行性能验证。参考美国临床和实验室标准协会CLSI文件的要求对六种GA酶法试剂的精密度、干扰因素、线性相关进行评估和验证。采用日本标准化委员会（ReCCS）提供的一份通过同位素稀释液相色谱串联质谱法（ID-LC/MS）赋值的冰冻血清验证GA%正确度。分析选取2016年1月本院门诊50例2型糖尿病患者与80名表观健康人群血清，用于六种GA试剂比对以及判断GA%异常符合率初步评估。参考EP28-A3C方案，从2016年1至2月北京协和医院查体人群中整群随机抽样选取122名表观健康人血清，对参考区间进行验证。结果六种试剂的精密度、抗干扰能力良好；六种试剂准确度的百分偏倚在-19.3%-9.2%之间；五种国产试剂A-E与进口试剂F测定GA%结果的相关性系数在0.966-0.999之间，平均绝对偏倚在7.0%-10.4%之间；A-E与试剂F判定GA%异常的一致率在88.5%-96.9%之间；改用临床初步评估的参考范围之后，其一致率均提高。结论应用于自动生化分析仪的六种GA酶法试剂，具有较高的精密度和较强的抗干扰能力，但是准确度仍需提高。Objective To validate the performance of six enzymatic glycated albumin reagents and evaluate their clinical application. Methods The performance of six enzymatic glyeated albumin reagents （labled as A, B, C, D, E, F） from Beijing Jiuqiang Co, Beijing Lideman Co, Ningbomeikang Co, Beijing Haomai Co, Sichuan Maike Co and Asahi Kasei Co were assessed on Olympus AU5800 automatic biochemistry analyzer. According to the standard of CLSI, the precision,interference and linear correlation of these reagents were assessed. To assess the accuracy of GA% , we used GA standard material whose value had been assigned using ID-LC/MS method provided by ReCCS. To do the method comparison and determine the consistency of assay, 50 fresh serum samples of T2DM outpatient and 80 fresh serum samples of apparently healthy people in Jan 2016 were tested using six kits. According to the EP28-A3C protocol, the reference range for GA% was validated in 122 apparently healthy individuals undertaking medical examination from January to February 2016 in PUMC. Results The precision, and the ability of anti - interference of the six reagents were good. The accuracy percentage deviation of six reagents was - 19. 3%-9. 2%. The correlation coefficient of domestic reagents A to E and imported reagents F in the determination of GA% was 0. 966-0. 999, the average absolute bias was 7. 0%-10. 4%. The coincidence rate of A-E and F in determining abnormal GA% was between 88. 5% and 96.9%. The coincidence rate was increased after switching to the reference range for preliminary clinical evaluation. Conclusion Six GA enzymatic kits used in automatic biochemical analyzer have high precision and strong anti-interference ability. Accuracy still needs to be improved.

关 键 词：血清白蛋白 酶测定 参考值 

分 类 号：R446.1[医药卫生—诊断学]