摘要
目的探讨不同的生化检测系统间血尿素氮（BUN）、肌酐（Cr）、尿酸（UA）三项指标测定结果的可比性，为本实验室不同检测系统检验结果的一致性提供依据。方法取中值和高值质控品分别在BeckmanLX-20和日立7600两种生化分析系统进行批内以及日间精密度检测，并以厂商声明和本实验室规定的精密度要求为评价标准。然后依据美国临床实验室标准化协会（CLSI）的EP9-A2文件，以BeckmanLX-20型生化分析仪为比较方法，以日立7600为实验方法，分别测定40例患者血清BUN、Cr、UA的含量，计算实验方法与比较方法之间的相对偏倚（SE％），并以各专业室间质量评价检验项目及可接受性能准则的规定为判断标准，判断不同生化分析系统的一致性。结果两种生化分析系统肾功能项目的批内CV和日间CV均低于厂商声明和本实验室规定的精密度要求，符合临床要求，比对实验数据可靠。日立7600的BUN在低中高三个医学决定水平的SE％分别为9．4％、2．0％、0．8％，Cr的SE％则为7．3％、3．8％、2．8％，UA的SE％为7．9％、1．7％、1．2％。而除BUN在低医学决定水平处的SE％超过了规定范围9％，两种生化分析系统不具可比性外，其余项目均低于可接受限，两种生化分析系统均一致。结论在一个实验室当同一检测项目存在两种或两种以上的检测系统时，应进行比对及偏倚评估，判断其一致性，以保证检验结果的可比性。
Objective To discuss the comparability of blood urea nitrogen （BUN）, creatinine （Cr）, uric acid （UA） results and provide basis for result concordance in different biochemical systems. Methods The within-run precision and the between-day precision for the median and high values of quality control materials were tested in Beckman LX-20 and Hitachi 7600 chemistry analyzer respectively, and the evaluation criteria were according to the precision requirement of manufacturer and our laboratory. According to American Clinical and Laboratory Standards Institute （CLSI） document EP9-A2, serum BUN, Cr, UA from 40 patients were detected by Hitachi 7600 chemistry analyzer as experimental method and by Beckman LX-20 chemistry analyzer as comparative method. The relative bias （ SE% ） between experimental method and comparative method was calculated and the concordance of biochemical analysis system was determined according to EQA requirements and acceptable performance criteria. Results The between-run and between-day precision coefficients of variation for BUN, Cr and UA in two biochemical analysis systems were lower than the precision requirement of manufacturer and our laboratory. In Hitachi 7600 chemistry analyzer, the SE% for BUN at three levels of medical decision were 9. 4%, 2. 0% and 0. 8% , the SE% for Cr were 7.3% , 3.8% and 2. 8% , the SE% for UA were 7.9% , 1.7% and 1.2%. Two biochemical analysis systems were not comparable in BUN analysis because SE% of serum BUN levels detected by Hitachi 7600 at low medical decision level exceeded the specified range. The remaining items between two biochemical analysis systems were concordant. Conclusion While the same test is detected by more than two systems in one laboratory, it is necessary to do method comparison and bias evaluation for concordance in order to ensure the comparability among test results.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2012年第6期550-553,共4页
Chinese Journal of Laboratory Medicine
基金
广西卫生厅科研课题资助项目（z2008158）
关键词
血尿素氮
肌酸酐
尿酸
临床化学试验
评价研究
Blood urea nitrogen
Creatinine
Uric acid
Clinical chemistry tests
Evaluation studies
作者简介
通信作者：李山，电子信箱：lis8858@126．com
