关键词: font-size:medium, ">体外诊断试剂；参考区间；验证；建立；审评要求

Abstract: The review points the key aspects of reference interval studies for in vitro diagnostic reagents， including the delineation of its applicable scope， the selection strategy of the path， the preconditions for verification， and the standardized requirements for establishment， and the concerns during the review process. By clarifying and refining these review requirements and Considerations， thereby offering a scientific and standardized guidance framework for relevant enterprises when conducting reference interval studies and compiling registration materials for in vitro diagnostic reagents. Simultaneously， it provides valuable reference information for professionals in the field of medicine， with the expectation of jointly promoting the scientificity， standardization， and accuracy of reference interval studies and review work for in vitro diagnostic reagents.

Key words: font-size:medium, "> , In vitro diagnostic reagents； Reference Interval； Verification； Establishment； Review requirements