ALT催化活性测定中不同厂家或批号试剂不确定度的评定  

Estimation on the uncertainty of ALT catalytic activity with different manufacturers or different lot numbers

作　　者：顾文超[1] 王惠民[1] 季伙燕[1] 王建新[2] 张卫威[1] 孟舒婷 许丽丽[1] 

机构地区：[1]南通大学附属医院检验科,江苏南通226001 [2]南通大学检验医学研究所,江苏南通226001

出　　处：《检验医学》2015年第11期1150-1156,共7页Laboratory Medicine

基　　金：国家质检总局资助项目(201210066)

摘　　要：目的研究不同厂家或同一厂家不同批号的α-丙氨酸、α-酮戊二酸、还原型β-烟酰胺腺嘌呤二核苷酸二钠盐（NADH）和三羟甲基氨基甲烷（Tris）对丙氨酸氨基转移酶（ALT）催化活性浓度的影响，评定ALT催化活性测定中不同厂家或批号试剂不确定度。方法按照国际临床化学和检验医学联合会推荐的ALT参考测量程序（37℃），分别测定S1～S5共5个浓度水平血清，用Bland-Altman法分析其一致性，并计算不同厂家或批号试剂间的不确定度。结果ALT试剂各成分（L-丙氨酸、α-酮戊二酸、NADH、Tris）不同厂家及批号的不确定度分别为0．90％、0．65％、0．58％、0．23％，对ALT催化活性浓度影响的扩展不确定度为2．54％（k=2）。结论要使各参考实验室所测定的ALT催化活性浓度结果更具可比性，应规定各使用试剂厂家及批号，并在不确定度评定中考虑不同厂家或批号试剂的不确定度。Objective To research the influence of L-alanine, alpha-ketoglutaric acid, beta-nicotinamide adenine dinueleotide reduced disodium salt hydrate （NADH） and Tris hydroxyl methyl aminomethane （Tris） coming from different manufacturers or different lot numbers on alanine aminotransferase （ALT） catalytic activity, and to evaluate the uncertainty of ALT catalytic activity with different manufacturers or different lot numbers. Methods The sera with 5 concentrations （S1-S5 ） were measured by the reference method （37 ℃ ） recommended by the International Federation of Clinical Chemistry and Laboratory Medicine. The consistency was analyzed by Bland-Altman method, and the uncertainties of ALT with different manufacturers or lot numbers were calculated. Results The uncertainties of L-alanine, alpha-ketoglutarie acid, NADH and Tris were 0. 90%, 0. 65%, 0. 58% and 0. 23%. The expanded uncertainties of different manufacturers or lot numbers of reagents were 2.54% （ k = 2）. Conclusions It is supposed to define every reagent manufacturer and lot number to make ALT catalytic activity measured by reference laboratories more comparable. When evaluating the uncertainty, we should consider the influence of reagents with different manufacturers or different lot numbers.

关 键 词：不确定度 丙氨酸氨基转移酶 催化活性 L-丙氨酸 Α-酮戊二酸 还原型β-烟酰胺腺嘌呤二核苷酸 二钠盐 三羟甲基氨基甲烷 

分 类 号：R446.1[医药卫生—诊断学]