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The theory of reference values: an unfinished symphony
Gerard Siest1, Joseph Henny, Ralph Gräsbeck
1University of Lorraine, Research Unit EA 4373, Génétique Cardiovasculaire, Nancy, France. Gerard.siest@univ-lorraine.fr
Clinical Chemistry and Laboratory Medicine
|November 28, 2012
Summary
The theory of reference values has evolved significantly since 1960, addressing biological variability and analytical challenges. Future directions include personalized reference values and assessing their clinical utility.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Biostatistics
Background:
- The concept of reference values evolved from the unclear notion of normality.
- Early work focused on biological variability, preanalytical conditions, and analytical standardization.
Observation:
- International recommendations and textbooks standardized reference value practices.
- New technologies and personalized medicine necessitate revisions to traditional reference values.
- Clinicians introduced decision limits and Reference Change Values (RCV), causing confusion.
Findings:
- Guidelines evolved with new statistical methods and exploration of multicenter and transferable reference intervals.
- The use of biobanks and 'Universal RIs' are emerging alternatives.
- The relevance of traditional reference intervals is questioned for continuous laboratory tests and complex disease states.
Implications:
- Individual reference values and RCV are crucial for personalized medicine.
- Further research is needed to integrate reference values effectively into medical decision-making.
- Collaboration between laboratory professionals and clinicians is essential for future advancements.
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