临床标本在验证生化试剂批间结果一致性中的应用  

Application of patient samples in verifying resuhs consistency after biochemistry reagent lot change

作　　者：王云秀[1] 雷艳梅[2] 文翠坤 林海标[1] 万泽民[1] 陈炜烨[1] 吴晓宾[1] 庄俊华[1] 王建兵[1] 

机构地区：[1]广东省中医院检验科,广州510120 [2]惠州市第一人民医院,516003 [3]广州市花都区花东镇中心卫生院,510890

出　　处：《国际医药卫生导报》2014年第24期3663-3666,共4页International Medicine and Health Guidance News

基　　金：国家科技重大专项（2012ZX09303009-003）;国家质检总局公益性行业科研专项（201210066）;广东省科技计划项目（2012KT1428）

摘　　要：目的探讨临床标本在验证不同批号生化试剂对临床检验结果是否具有一致性的作用。方法分别使用新旧两个批号试剂对5个不同浓度的新鲜血清标本、Roche配套质控品和Biorad质控品的13常规临床生化项目进行测定，并对结果进行统计学分析。计算各项目更换试剂批号前后之间的偏移，以美国临床医学检验部门修正法规（CLIA’88）允许总误差的1／3为标准，判断结果是否在允许范围内。结果各项目在更换试剂批号后质控结果差异无统计学意义（P〉0．05），而临床标本中的丙氨酸氨基转移酶（ALT）、尿酸（UA）、总胆固醇（TC）和载脂蛋白A（APOA）等四个项目的测定结果却有统计学意义（P〈0．05），但其偏移却在1／3CLIA’88可接受范围内，分别为2．57％、4．41％、1．81％和3．84％，可以满足临床需要。结论由于质控品基质效应的存在，质控品的结果并不能真实反应更换试剂批号后临床标本结果的一致情况，为了解决这个问题，建议最好同时使用质控品和临床标本进行更换试剂前后的比对。Objective To study the role of clinical patient samples in verifying consistency of clinical results between different reagent lots. Methods The results of 5 clinical samples, Roche quality control materials and Biorad quality control materials for 13 clinical routine biochemical tests were obtained by using both old and new reagent lot, and performed the statistics. The bias of 13 measurands were computed after changing reagent lots, and also were judged according to the 1/3 limits of CLIA＇ 88 defined acceptable error, whether the bias was conform to clinical requirements or not. Results QC material results had no significant difference between two reagent lots （P 〉 0.05）. The results of ALT, UA, TC and ApoA for patient samples had significant difference （P 〈 0.05）, but the bias of these items were within the 1/3 limits of CLIA＇ 88 defined acceptable error, which were 2.57%, 4.41%, 1.81% and 3.84% respectively, in accordance with clinical requirement. Conclusions As there is matrix effect of quality control materials, the results for Qc materials should not be used to verify the consistency of results for patient samples when changing reagent lots. To overcome this situation, we should use quality control materials together with clinical samples to compare consistency of results after changing reagent lots.

关 键 词：试剂批号 临床标本 质控品 基质效应 

分 类 号：R446[医药卫生—诊断学]