摘要
目的探讨用γ-谷氨酰基转移酶(GGT)参考方法校正自建GGT检测系统的效果。方法用GGT参考方法对患者新鲜血清赋值,校准常规检测系统。用参考方法和常规检测系统同时检测3份室间质控品、4份市售制备物和5份新鲜血清,进行检验结果的可比性和基质效应的评价。结果在用参考方法赋值的血清校准常规检测系统前,常规检测系统4,5,9与参考方法之间在医学决定水平处的偏倚均大于10%,系统8与参考方法之间在医学决定水平低值处的偏倚大于10%,系统1,2,3,6,7与参考方法之间在医学决定水平处的偏倚小于10%;校准后各检测系统与参考方法之间在医学决定水平处的偏倚均小于10%。校准后常规检测系统与参考方法测定4份市售制备物、3份室间质控品和5份新鲜血清标本结果之间的偏倚大于±5%的比率分别为38.9%,33.3%,4.4%。结论用参考方法赋值的新鲜血清进行可溯源的正确度传递,可解决临床化学检测结果的溯源性和可比性问题。
Objective To explore the application of reference procedure for the measurement of gamma-glutamyhransferase (GGT). Methods The routine assays were calibrated by the serum GGT levels, which were measured by the reference procedure. The GGT in three external quality materials, four commercially available samples, and five fresh sera was measured in parallel by the routine assays and the reference procedure. Results Before the routine assays were calibrated,the difference of GGT levels measured by each of rou- tine assays 4,5 ,and 9 and by the reference procedure was higher than 10%. The bias of low value between routine system 8 and the reference procedure was exceeded 10%. The bias of GGT between each of routine assays 1,2,3,6, and 7 and the reference procedure was less than 10%. The percentage of the bias more than ± 5% between each of the routine assays and the reference procedure was 38.9% ,33.3% ,and 4.4% in measuring GGT in the commercially available samples,external quality materials,and fresh sera respectively. Conclusions Fresh serum in which GGT activity was assigned by the reference procedure may be used to dissolve the issues of the traceability and comparability.
出处
《临床检验杂志》
CAS
CSCD
北大核心
2009年第5期331-333,共3页
Chinese Journal of Clinical Laboratory Science
基金
国家科技支撑计划项目(2006BAI14B00)子项目
广东省医学科研基金(A2009242)