摘要
目的通过对不同检测系统血清酶测定进行方法比对和偏倚评估,探讨不同检测系统间血清酶测定结果的可比性,为不同实验室检验结果的互认和实验室认可提供实验数据. 方法参考NCCLS的EP9-A2文件,以日立7170生化分析仪、罗氏原装试剂、C.f.a.s校准品和质控品组成的检测系统（已通过ISO/IEC 17025标准认可）为目标检测系统（比较方法）,检测系统1～4为实验方法,用病人新鲜血清对丙氨酸氨基转移酶（ALT）、碱性磷酸酶（ALP）、天冬氨酸氨基转移酶（AST）、乳酸脱氢酶（LDH）和肌酸激酶（CK）进行检测,计算实验方法（Y）和比较方法（X）之间的相对偏差（% SE）,以美国临床实验室修正法规（CLIA＇88）规定的室间质量评价允许误差范围的1/2为标准,判断不同检测系统测定结果的可比性. 结果除检测系统4的ALT结果、检测系统1 ALP测定的高值（＞150 U/L）、检测系统3和检测系统4的AST结果与比较方法的系统误差不能被接受外,其余项目测定结果的系统误差临床可以接受. 结论当用两个以上的检测系统检测同一检验项目时,应进行方法比对和偏倚评估,判断其临床可接受性能,以保证检验结果的可比性.
Objective The comparability of serum enzyme results of different biochemical detecting system were studied through bias estimation and method comparison. Method Following NCCLS document EP9-A2, different biochemical detecting system, detecting system 1-4 （laboratory method） and detecting system 5 （ comparison method, which includes Hitachi 7170 biochemical analyzer, reagent of Roche, C.f. a.s. calibrator and controller of Roche, and have accredited by ISO/IEC 17025 ） , were used respectively to 5 serum enzyme items including ALT, AST, ALP, LDH and CK to obtain the correlation coefficient and the linear equation. Then the coefficient and the equation were used to evaluate the system bias between laboratory method and comparison method. We judge the comparability of different investigate systems according to the half of CLIA＇88 standard. Results The system bias of ALT （ system 4）, ALP at higher value （system 1 ）, AST（ systems 3 and 4） were not acceptable, the rest could be accepted. Conclusion If the same test are determined by more than two systems, it is necessary to do method comparison and Bias estimation for judge clinical acceptability in order to insure the comparability.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2006年第4期346-349,共4页
Chinese Journal of Laboratory Medicine
基金
国家高新技术研究发展计划重大专项资助课题(2004AA2Z3762)
关键词
血清
比对研究
偏差
实验室
Serum
Comparative study
Uncertainty
Laboratories
