5种浓度水平冰冻混合人血清ALT、AST二级标准品的研制  

Five different levels of secondary standard reference material of transaminase prepared with mixed freezing human serum

作　　者：夏昌宇[1] 徐国宾[1] 刘欧[2] 李海霞[1] 刘岩[1] 齐丽丽[3] 何振坤[3] 徐静[4] 黄宪章[5] 庄俊华[5] 王兰珍 张雪莲 于琴 刘牧龙 

机构地区：[1]北京大学第一医院检验科,北京100034 [2]清华大学第一医院检验科,北京100016 [3]中生北控生物科技股份有限公司,北京102200 [4]北京朝阳医院检验科,北京100020 [5]广东省中医院检验科,广州510120 [6]北京利德曼生化技术有限公司,北京100176 [7]深圳迈瑞生物医疗电子股份有限公司,深圳518017

出　　处：《临床检验杂志》2011年第2期140-143,共4页Chinese Journal of Clinical Laboratory Science

基　　金：国家十一五科技支撑计划资金资助(2007BA105B09);国家高技术研究发展计划(863计划)资金资助(2006AA020909)

摘　　要：目的研制5个浓度水平冰冻混合人血清丙氨酸氨基转移酶(ALT)和天冬氨酸氨基转移酶(AST)二级标准品,为常规检测ALT、AST提供稳定性和互通性良好的准确度验证材料和校准品。方法收集无脂血、溶血的含ALT和AST的5个浓度水平的混合人血清,滤菌后分装于冻存管中,(-70±2)℃保存。采用单因素方差分析检验该标准品的均匀性,并观察其在15～25℃(室温)、2～8℃和-70℃的稳定性。4家实验室采用国际临床化学联合会(IFCC)推荐的含和不含磷酸吡哆醛(PLP)参考方法对标准物质定值,并评定不确定度。观察血清物质在7种进口配套检测系统的互通性,并用直线回归分析进行评价。结果血清物质均匀性良好(P>0.05),稳定性在15～25℃和2～8℃时能满足使用要求,-70℃保存至少稳定1年。4家实验室对该标准品的定值结果具有一致性,总体不确定度较小。血清物质的互通性良好,仅浓度4和5在含PLP的方法间互通性稍差。结论研制的5水平冰冻混合人血清均匀性、稳定性、互通性良好,定值准确,可用作ALT、AST的二级标准品。Objective To prepare a stable secondary standard reference materials of serum transaminase（alanine aminotransferase and aspartate aminotransferase） for accurate value of of serum transaminase level in routine measurement.Methods Human sera without hemolysis and lipemia were pooled which covered 5 different levels of the linearity measuring range.After filtration for sterilization,the mixed sera were distributed into freezing tubes（0.5ml per vial） and stored at-70 ℃±2 ℃.Transaminase levels in the mixed sera were assessed in 4 laboratories with the recommended reference method recommended by International Federation of Clinical Chemistry（IFCC） containing or non-containing pyridoxal phosphate（PLP）.The consistency of transaminase level in the sera measured by 7 commercial biochemical analysis systems and the results were evaluated by linear regression.The homogeneity of the materials was analyzed by one-way ANOVA.The stabilities of materials for short-term and long-term were studied at room temperature（15-25 ℃）,4 ℃ and-70 ℃ respectively.Results The sera materials were verified to be homogeneous and stable enough for use when stored at room temperature and 4 ℃,and could be preserved at-70 ℃ for at least one year.The measured values from 4 laboratories were of high consistency with small uncertainties.The materials prepared by mixed sera were proved to be consistent with each other except the level 4 and level 5 which showed a little variation induced by matrix effect of PLP.Conclusion The prepared 5 levels of frozen sera materials were homogeneous,stable and intercommunicatable.All the 5 levels of material may achieve accurate measuring values and serve as the secondary standard reference material of serum transaminase.

关 键 词：转氨酶 均匀性 稳定性 互通性 标准参考物质 

分 类 号：Q555.6[生物学—生物化学] R446.1[医药卫生—诊断学]