酶法测定糖化白蛋白的方法性能验证及其初步临床应用  

Analytical performance and clinical application of glycated albumin detection by enzymatic method

作　　者：赵芳[1] 张芳[1] 邱玲[1] 程歆琦[1] 国秀芝[1] 陈雨[1] 齐志宏[1] 郝英英[1] 迟书玲[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》2013年第4期343-347,共5页Chinese Journal of Laboratory Medicine

摘　　要：目的验证酶法检测血清糖化白蛋白（GA）性能，评价临床应用价值。方法本研究属于验证性研究。参考美国临床和实验室标准协会（CLSI）EPl7-P、EP6．A、EPl5-A、Efr7．P方案对该项目的定量检测下限（LoQ）、线性范围、精密度、干扰因素进行验证，采用制造商提供的主校准品及3份通过高压液相色谱法（HPLC）赋值的冻干血清验证GA％正确度。使用该方法在BECKMAN AU5400、ROCHEMODULAR P、HITACHl7180及BECKMANDXC600共4种不同品牌自动生化分析仪上，检测从2012年3月份门诊患者剩余血清标本中分类随机抽样选取50份新鲜血清标本，并比对结果一致性。参考CLSIC28-A3方案，从2012年2至3月查体人群中整群随机抽样选取452名表观健康人血清，对参考区间进行验证，分析选取2012年10至12月在北京协和医院内分泌科门诊就诊的61例2型糖尿病（T，DM）患者经口服降糖药治疗30-45d，比较患者血清中GA％与糖化血红蛋白（HbAIS）的相关性。结果自动生化分析仪的LoQ为0．28g／L；线性范围为0．28～36．1g／L（R。=0．9997）；重复性cy为0．6％～1．5％，实验室内再现性cy为1．3％～2．1％，均小于试剂盒声明不精密度；3种干扰物在试验浓度内（胆红素≤659 μmol／L、血红蛋白≤0．966g／L及乳糜≤1530FTu）的偏差分别为-3．80％，-4．03％及-1．34％；正确度验证显示测定值与HPLC赋值偏倚为-1．2％～1．53％；4个生化检测系统GA％结果与均值的回归方程分别为Y=1．0216X－0．0449（R2＝0．9991）、Y=0．9963X＋0．0423（R2=0．9990）、Y=0．9776X＋0．075（R2=0．9995）、Y=1．0245X～0．0367（R。=0．9906），偏差分别为0．5％～3．3％、－2．4％～1．9％、－2．9％～－0．7％、－1．9％～5．O％；452名表观健康人血清GA％的95％置信区间为11。3％一15．6％；GA％与HbA。。呈显著相关（r=0．812，P〈0．01），回归方程为GObjective To verify the various performances of the enzymatic method that is used to detect the glycated albumin （GA） on automatic biochemistry analyzer and to apply it in clinic preliminary. Methods This verification study validated the limit of quantitation, linearity, imprecision, interferences （bilirubin, hemoglobin, chyle） of GA assay according to the CLSI EP17-P, EP6-A, EP15-A, EP7-P protocol. To assess the accuracy of GA assay, we used manufacturer＇s secondary standard material and three level freeze-dry serum that values have been assigned using HPLC method. To determine the consistency of assay, 50 fresh serum samples of outpatient in Mar 2012 were tested using this kit on four automatic biochemistry analyzer （BECKMAN AU5400, ROCHE MODULAR P, HITACHI7180, BECKMAN DXC600）, According to the CLSI C28-A3 protocol, the reference ranges for GA% were validated in 452 apparently healthy individuals undertaking medical examination from Feb to Mar 2012. 61 subjects withT2DM treated in the endocrinology department of PUMC Hospital from Oct. to Dec. 2012 were enrolled in the study. GA% and HbAIC. were determined respectively after they finished their 30 - 45 day oral hypoglycemic agent therapy. The correlation between GA% and HbAlC were analyzed. Results The limit of quantitation was 0. 028 g/dl; the linearity was 0. 028 - 3.61g/dl （ R2 = 0. 9997 ） ; repeatability CV was 0. 6% - 1.5% and reproducibility CV was 1.3% -2. 1%. The imprecision were lower than that declared by assay producer. When bilirubin≤659 trmol/L, hemoglobin ≤0. 966 ~g/L and chyle turbidity ≤1530 FTU, the deviation was -3.80%, -4. 03%, - I. 34% respectively. For the accuracy based tests, the bias% of enzymatic method were - 1.2% - 1.53%, when compared to HPLC. The regression equations of GA% were as follows ： Y = 1. 0216X - O. 0449 （ R2 = O. 9991 ）, Y = 0. 9963X ＋ O. 0423 （ R2 = 0. 9990 ）, Y = O. 9776X ＋ 0. 075 （ R2 = 0. 9995 ）, Y = 1. 0245X - 0. 0367 （ R2 = 0. 9906 ）, respectively. The bias were 0. 5 %

关 键 词：血清白蛋白 临床酶试验 参考值 敏感性与特异性 

分 类 号：R737.9[医药卫生—肿瘤]