摘要
定量检测项目在正式用于患者标本检测前或检测系统有重大改动后,需对厂商提供的或引用专业文献的相关方法学分析性能予以证实,需证实的方法学性能包括准确度、精密度、灵敏度、特异性、可报告范围、参考区间等。不同检测项目和不同的检测系统需选择证实的分析性能实验各不相同,每种方法学验证实验进行的先后顺序亦有所不同,实验室需对进行的方法学验证实验进行合理选择、系统设计。
Before a quantitative test can be used in patient testing or after major maintenance or change for the original testing system, a laboratory must verify in full method performance information obtained from either manufactures or published academic literature. There are many types of method performance we need to verify, including analytic accuracy, precision, analytic sensitivity, analytic specificity ,reportable range and reference range. In this article, we describe how to select the appropriate method performance validation experiments depending on different test items and test systems, and how to design the sequence of the experiments for quantitative tests in clinical laboratory.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2007年第2期143-145,共3页
Chinese Journal of Laboratory Medicine
关键词
诊断技术和方法
评价研究
Diagnostic techniques and procedures
Evaluation studies
