摘要
目的对测定乳酸脱氢酶(LDH)的国产与进口诊断试剂的可比性及偏倚进行评估。方法按NCCLSEP9-A文件,每天选择高、中、低值临床血清标本8例,分别用中生试剂(实验组)和罗氏试剂(对照组)进行LDH测定。每份标本正序、倒序各测定1次,连测5d,共计40例标本。记录结果并做统计学分析。结果进口罗氏和国产中生2种LDH诊断试剂对临床标本LDH的检测结果显示,方法内重复性检查DX′i≤4DX′,DY′i≤4DY′;离群点检查Eij≤4E,Eij′≤4E′;线性回归r2=0.9988;系统误差的估计值及其置信区间|B^Clow,B^Chigh|<允许误差;系统误差符合临床要求。结论国产中生试剂与进口罗氏试剂测定LHD的结果之间具有良好的可比性和相关性。
Objective To evaluate the comparability and the bias of serum LDH（lactate dehydrogenase） results determined by domestic LDH diagnostic reagent and import diagnostic reagent. Methods According to the NCCLS EP9-A document,eight serum samples with high-middle-and low-LDH value were selected and the control group was determined by the imported Roche Diag-hostic reagent,the experimental group was detected by the domestic Zhongsheng Diagnostic reagent. The LDH determination of each sample was carried out by OLYMPUS AU5421 automatic biochemical analyzer in order and reverse order with Zhongsheng LDH reagent and Roche LDH reagent respectively. All the 40 patient samples were analyzed in 5 continuous working days. These results were recorded and statistical analysis was performed. Results About two types of LHD diagnostic reagent, Roche and Zhongsheng,the LDH detection of clinical specimens showed that the repetitive inspections within methods were DX＇i≤4DX＇ and DY＇≤4DY＇ Outlier＇checks were Eij≤4E and Eij≤4E＇ ; Linear regression R^2 = 0.998 8 ; Systematic error estimates and confidence interval ｜Bclow,Bchigh｜〈 were less than Permissible error; systematic error was in line with the clinical requirements. Conclusion There was a well comparability and. positive correlation between the results of LDH determined by the domestic Zhongsheng reagent and the imported Roche diagnostic reagent.
出处
《国际检验医学杂志》
CAS
2010年第10期1062-1063,1066,共3页
International Journal of Laboratory Medicine
基金
国家高技术研究发展计划(863计划)(编号:2006AA020901)
关键词
L-乳酸脱氢酶
指示剂和试剂
诊断
对比研究
L-Lactate Dehydrogenase
Indicators and Reagents
Diagnosis
Comparative Study
