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Table. 1.

Table. 1.

Differences among reference intervals, clinical decision limits, and functional reference limits, adapted from [2]

Type of interpretative tool Reference intervals Clinical decision limits Functional reference limits
Number of values Statistical limits (two values) Clinical threshold (typically one value) Biological and/or statistical limit (typically one value)
Derivation A biological characteristic of the unaffected population A decision regarding a clinical condition An inflection point of a functional relationship between two interrelated biomarkers
Population General population Clinical population General and clinical populations
Based on 95% central interval of the reference distribution Clinical outcome studies, guidelines and consensus values, ROC curves, predictive values Numerical threshold at which the relationship between physiologically related components, such as laboratory biomarkers, changes significantly
Defined by Laboratory experts Clinicians and laboratory experts Laboratory experts
Most prominent experts Laboratory experts Clinical experts Laboratory experts
Consensus standard Well defined To be developed To be developed
Ann Lab Med 2023;43:408~417 https://doi.org/10.3343/alm.2023.43.5.408

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