血清葡萄糖参考方法的复现及与临床常用检测方法的比对研究  

Reproduction of reference method for serum glucose detection and comparison with routine glucose kits

作　　者：贾珂珂[1] 陈文祥[2] 张捷[1] 李国权[1] 

机构地区：[1]北京大学第三医院检验科,100191 [2]北京大学第三医院卫生部临床检验中心,100191

出　　处：《中华检验医学杂志》2009年第3期346-351,共6页Chinese Journal of Laboratory Medicine

基　　金：国家科技支撑计划资助项目（2007BA105809）

摘　　要：目的复现血清葡萄糖测定己糖激酶的参考方法（紫外分光光度法），对此方法进行性能验证，并评价5种临床常用检测方法。方法按照美国CDC推荐的血清葡萄糖测定己糖激酶参考方法的要求，建立参考方法；通过测定标准参考物质（SRM），以及参加国际临床化学与检验医学联合会（IFCC）主办的参考实验室间的国际环形比对试验（ring-trial），来验证参考方法的准确性；按照美国临床和实验室标准委员会（CLSI）EP9-A2试验方案，己糖激酶参考方法作为比对方法，5种临床常用检测方法作为待评方法，同时测定40份血清样品。结果用己糖激酶参考方法测定SRM965a，水平2和水平3与靶值的偏倚分别为0．93％、-0．23％；参加参考实验室国际比对，血清葡萄糖检测结果在可接受范围内；5种常用检测方法在医学决定点（Xc=6．11mmol／L）预期偏差的95％可信区间在实验室定义的可接受偏差（10％）范围内，也在生物学变异的可接受偏差（6．9％）范围内。结论本室已复现并验证了血清葡萄糖测定己糖激酶参考方法；5种常用血清葡萄糖检测方法的测定结果与参考方法的测定结果有差异，但误差在临床可接受范围，不会影响临床检测结果。Objective To reproduce and validate the hexokinase reference method for glucose detection and compare other 5 routine glucose kits with this reference method. Methods The CDC hexokinase reference method for glucose detection was established and the performance was validated through testing a standard reference material （SRM） and participating in the IFCC ring-trial for reference laboratories for glucose evaluation. The CLSI EP 9-A2 protocol was used to compare the 5 routine glucose kits with the hexokinase reference method. Forty serum samples were analyzed by 5 routine kits and the hexokinase reference method. Results When SRM 965a was determined by the reference method, the bias of level 2 and level 3 were 0. 93% -0. 23% respectively. The results for IFCC ring trial were within the accepted range. For the 5 routine kits, the confidence intervals of the predictive bias at the medical decision point Xc （Xc = 6. 11 mmol/L） were all within the range of defined acceptable error （ 10% ） and the range of biological variation bias （6. 9% ）. Conclusions The hexokinase reference method for serum glucose was reproduced in our lab. The serum glucose results measured with 5 routine kits were different from results detected with the reference method, but the bias was acceptable, and it will not affect the detection results.

关 键 词：血糖 参考标准 己糖激酶 分光光度法 紫外线 评价研究 

分 类 号：R686[医药卫生—骨科学]