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The evolution of the reference value concept
1Minerva Foundation Institute for Medical Research, Biomedicum Helsinki, Helsinki, Finland. ralph.grasbeck@fimnet.fi
Clinical Chemistry and Laboratory Medicine
|August 26, 2004
Summary
The concept of reference values in laboratory medicine evolved from ambiguous "normal values" to standardized interpretations based on control subjects. This shift, driven by international collaboration, improved clinical measurement accuracy.
Area of Science:
- Clinical Biochemistry
- Laboratory Medicine
- Biostatistics
Background:
- The ambiguity of traditional
- normal values
- in laboratory medicine prompted a re-evaluation of clinical measurement interpretation.
- The lognormal distribution of population laboratory results, rather than Gaussian, highlighted the limitations of existing standards.
Observation:
- A new concept of reference values, emphasizing interpretation against proper control subjects, was introduced in 1969.
- International, regional, and national societies developed expert panels to establish recommendations for reference values.
Findings:
- Recommendations cover principles, terminology, health concepts, specimen collection, preanalytical factors, statistical treatment, data stratification, and relating patient values to reference values.
- The importance of correct terminology and considering the purpose of laboratory tests is highlighted.
- New developments, including reference change values, are emerging.
Implications:
- Standardized reference values enhance the accuracy and reliability of clinical laboratory diagnostics.
- International teamwork has been crucial in advancing the field of reference values.
- Proper interpretation of laboratory results against appropriate reference values is essential for effective patient care.