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Body:The statistical interpretation of bioequivalence data is a significant aspect of pharmaceutical research. Bioequivalence refers to the absence of any significant difference in the rate and extent to which the active ingredient in pharmaceutical products becomes available at the site of drug action when administered at the same molar dose under similar conditions. This helps determine if different drug products have similar absorption rates, ensuring their interchangeability.Statistical...
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Personalized Reference Intervals Versus Indirectly Estimated Population-Based Reference Intervals for Hematology

Ozlem Demirelce1, Berrin Bercik Inal2, Abdurrahman Coşkun3

  • 1Department of Medical Biochemistry, University of Health Sciences, Göztepe Training and Research Hospital, Istanbul, Turkey.

International Journal of Laboratory Hematology
|December 8, 2025
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Summary

Personalized reference intervals (prRIs) offer more accurate interpretations of complete blood count (CBC) results than population-based reference intervals (popRIs). This study demonstrates significant differences between prRIs and popRIs for various CBC parameters.

Keywords:
biological variationcomplete blood counthematologypersonalized reference intervalpopulation‐based reference interval

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Area of Science:

  • Clinical laboratory science
  • Hematology
  • Biostatistics

Background:

  • Accurate interpretation of laboratory data relies on reliable reference intervals (RIs).
  • Population-based reference intervals (popRIs) are standard, but personalized reference intervals (prRIs) derived from individual data offer improved accuracy.
  • This study compares prRIs with popRIs for common hematology parameters.

Purpose of the Study:

  • To estimate personalized reference intervals (prRIs) for common hematology parameters.
  • To compare these prRIs with population-based reference intervals (popRIs).
  • To evaluate the utility of prRIs for clinical decision-making in hematology.

Main Methods:

  • Population-based reference intervals (popRIs) were estimated for 17 complete blood count (CBC) subparameters using patient laboratory data.
  • Personalized reference intervals (prRIs) were calculated for the same parameters using longitudinal data from 200 healthy individuals via a prediction interval model.
  • The reference interval index (RII) was computed as the ratio of the prRI range to the popRI range for each measurand.

Main Results:

  • Personalized reference intervals (prRIs) for CBC parameters showed significant differences compared to population-based reference intervals (popRIs).
  • The median reference interval index (RII) ranged from 0.41 for eosinophils to 2.97 for platelet distribution width (PDW).
  • These findings indicate variability in how individual RIs deviate from population norms.

Conclusions:

  • Personalized reference intervals (prRIs) for CBC parameters demonstrably differ from their corresponding population-based reference intervals (popRIs).
  • The use of prRIs is recommended for a more precise interpretation of patient CBC results.
  • Implementing prRIs can enhance the accuracy of clinical decision-making in hematology.