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Multicentric reference values: shared reference limits

M Ferré-Masferrer1, X Fuentes-Arderiu, V Alvarez-Funes

  • 1Servei de Bioquímica Clínica, Ciutat Sanitària i Universitària de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.

European Journal of Clinical Chemistry and Clinical Biochemistry : Journal of the Forum of European Clinical Chemistry Societies
|November 14, 1997
PubMed
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Three laboratories created shared reference limits by simulating a virtual laboratory. This multicentric approach for clinical chemistry reference values proved largely successful, with minor exceptions for calcium and urate.

Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Biochemical Analysis

Background:

  • Establishing shared reference limits across laboratories is crucial for consistent clinical decision-making.
  • Geographically close laboratories with homogeneous populations offer an opportunity for multicentric reference value studies.

Purpose of the Study:

  • To develop and validate a multicentric strategy for generating shared reference limits using a virtual laboratory approach.
  • To assess the diagnostic specificity of these multicentric reference limits.

Main Methods:

  • Three laboratories collaborated, simulating a virtual laboratory by blending individual reference values.
  • 171 reference individuals and 15 common biochemical quantities were analyzed.
  • The Harris & Boyd test was used to determine the permissibility of blending data.

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  • Multicentric reference limits were estimated following International Federation of Clinical Chemistry guidelines.

    • Main Results:

    • The virtual laboratory approach successfully generated multicentric reference limits for most biochemical quantities.
    • Diagnostic specificity was evaluated using these limits as cut-offs, comparing observed values to the theoretical 0.975.
    • The multicentric reference limits were valid with the exception of upper limits for serum calcium(II) and urate in one laboratory.

    Conclusions:

    • The virtual laboratory model is a viable strategy for producing shared reference limits in clinical chemistry.
    • This approach enhances the consistency and comparability of biochemical test results across different laboratories.
    • Minor adjustments may be needed for specific analytes like calcium and urate in certain laboratory contexts.