现代检验医学杂志2012，Vol.27Issue(2)：66-69,4.DOI:10.3969/j.issn.1671-7414.2012.02.023
不同评价方案在临床比对试验应用的方法学探讨
Method Comparation Study Using Different Evaluation Criteria
曾宪飞 1李军民 1谈昀 1王小刚1
作者信息
- 1. 武警陕西省总队医院检验科,西安710054
- 折叠
摘要
Abstract
Objective To study the agreement of three different evaluation criteria for assessing the clinical acceptability in method comparation study. Methods Comparative study was performed based on document EP9-A2. The clinical acceptability of two biochemical analyzers was estimated by EP9-A2 criterion,Bland-Altman analysis and 1/2 CLIA'88 Tea criterion. Results The results obtained by three evaluation criteria were not all the same. At medical decision level 3 of alanine amin-otransferase(ALT) the results evaluated by EP9-A2 criterion and 1/2CLIA'88 Tea criterion were different. Conclusion The ability of detecting potential bias was different among the three criteria. In comparative study should choose adaptive criterion based on requirements for clinical test.关键词
一致性/比对研究/质量管理Key words
consistency/comparative study/quality management分类
医药卫生引用本文复制引用
曾宪飞,李军民,谈昀,王小刚..不同评价方案在临床比对试验应用的方法学探讨[J].现代检验医学杂志,2012,27(2):66-69,4.
