自建免疫检测系统测定结果的可比性研究  

Comparability research of self-developed immunochemistry detection system

作　　者：汪丽儿[1] 欧成举[1] 

机构地区：[1]安徽芜湖皖南医学院附属弋矶山医院检验科,241001

出　　处：《国际检验医学杂志》2011年第9期957-958,960,共3页International Journal of Laboratory Medicine

摘　　要：目的评价两台全自动生化分析系统间的差异,确保使用两系统进行特种蛋白测定时结果的一致性。方法参考临床实验室标准化委员会(CLSI)文件EP9-A2评价进行整个比对过程,比对项目为常规的9种特种蛋白。结果两系统IgA、IgG、IgM和C反应蛋白(CRP)4个项目的低、中、高值测定结果的批内精密度(CV)<2.79%;9个项目的测定结果相关系数(r)>0.975,在医学决定水平处(Xc)的预期偏差(Bc)除IgA高值和类风湿因子(RF)项目外均小于允许误差(EA)。结论两系统间差异在临床可接受范围内,自建检测系统可向临床提供准确的一致性报告。Objective To evaluate the difference between two immunochemistry systems to ensure the concordance of them in the detection of special proteins. Methods Method comparison was performed according to the document EP-A2 of Clinical and Laboratory Standard Institute（CLSI） including nine routine test items of special proteins. Results The within-run precision（CV） of the two systems were both lower than 2.79 %, when samples with low, medium and high value of IgA, lgG, IgM and CRP were detected. The correlation coefficient of the nine test items between the two systems were all higher than 0. 975. Expected bias（Bc） at medical decide level（Xc） were less than acceptable error（EA）, with the exception of high value of IgA and rheumatoid factor（RF）. Conclusion The difference between the two systems is in the clinical allowable range. The self-developed detection system can pro vide accurate and coincidental report for clinic.

关 键 词：比对研究 误差 免疫检测系统 

分 类 号：R446.6[医药卫生—诊断学]