定量体外诊断试剂参考区间建立与临床评价关系探究

Relationship between Reference Interval Establishment and Clinical Evaluation in Quantitative in Vitro Diagnostic Reagents

摘要: 参考区间研究和临床评价是证明体外诊断试剂预期用途的两项重要支持性证据。概述了参考区间确定过程和临床评价的注意点，从溯源性、预期用途以及分层设计三方面分析了两者之间的关系，并提出了指导建议。

Abstract: Reference interval study and clinical evaluation are crucial supportive researches to demonstrate the intended use of quantitative in vitro diagnostic reagents. The process of determining reference interval, as well as the problems found frequently in clinical evaluation, are discussed here, and the links between them are analyzed from the aspects of product’s traceability, intended use and group design. Further, some suggestions are offered in this paper.