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Related Experiment Video

Updated: Apr 18, 2026

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
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[The concept of reference change values (RCV). Will it supersede reference intervals?].

Brigitte Walz1, Walter Fierz2

  • 1Kantonsspital Graubünden, Zentrallabor, Chur.

Therapeutische Umschau. Revue Therapeutique
|January 30, 2015
PubMed
Summary

Reference values help assess lab results, but the reference change value (RCV) offers a more personalized approach. RCV detects early pathological changes by considering measurement imprecision and biological variability, improving clinical decisions.

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Area of Science:

  • Clinical Chemistry and Hematology
  • Biostatistics
  • Medical Diagnostics

Context:

  • Laboratory values are typically compared to population-based reference ranges to identify abnormalities.
  • Distinguishing early pathological changes from normal biological variation can be challenging with standard reference ranges.
  • Accurate interpretation is critical during the nascent stages of a disease process.

Purpose:

  • To introduce the concept of the reference change value (RCV) as a superior metric for interpreting laboratory results.
  • To highlight the limitations of traditional population-based reference ranges in detecting subtle pathological changes.
  • To emphasize the importance of personalized reference limits in clinical decision-making.

Summary:

  • The reference change value (RCV) is calculated using measurement imprecision (1-5%) and within-person biological variability (≥100%).
  • RCV defines the minimum difference between two measurements to be considered significant, irrespective of population reference ranges.
  • This allows for the detection of significant changes before laboratory values exceed established normal ranges.

Impact:

  • Utilizing RCV improves the accuracy of clinical decision-making for numerous analytes in clinical chemistry and hematology.
  • Focusing on an individual's personal normal range, informed by RCV, enhances diagnostic sensitivity for early disease detection.
  • This personalized approach provides a more clinically relevant interpretation of laboratory data compared to population norms.