pISSN 2234-3806eISSN 2234-3814
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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