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

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.

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Yao Cai, Wenzhu Fu, Yang Fu, Li Guo, Jiafa Xu. Relationship between Reference Interval Establishment and Clinical Evaluation in Quantitative in Vitro Diagnostic Reagents]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation. 2021 Jun 08;45(3):326-329

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PMID: 34096246

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