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Prerequisites for establishing common reference intervals.

P Hyltoft Petersen1, P Rustad

  • 1Department of Clinical Biochemistry, Odense University Hospital, Odense, Denmark.

Scandinavian Journal of Clinical and Laboratory Investigation
|June 30, 2004
PubMed
Summary
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Establishing common reference intervals requires standardization and traceability for accurate laboratory results. This ensures reliable health data across different populations and analytical methods.

Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Biostatistics

Background:

  • Common reference intervals require robust standardization and traceability, building upon existing International Federation of Clinical Chemistry (IFCC) recommendations.
  • External quality control systems must utilize matrix-matched materials traceable to reference methods for reliable validation.

Purpose of the Study:

  • To outline the prerequisites and strategies for establishing common reference intervals for homogeneous populations.
  • To highlight the importance of standardization, traceability, and appropriate quality control for reliable health data.

Main Methods:

  • Discusses two measurement strategies: immediate analysis versus sample storage, each with implications for standardization and stability.
  • Emphasizes the need for large sample sizes from diverse subgroups (age, gender, ethnicity, environment) to reduce confidence intervals.

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  • Stresses the importance of clearly defined health criteria and exclusion rules for selecting reference individuals.

    • Main Results:

    • Common reference intervals necessitate rigorous standardization and traceability in reference value production and laboratory application.
    • External quality control must use traceable, matrix-correct materials and analytical quality specifications tailored for common intervals.
    • Large sample sizes from diverse subgroups enable precise reference limits and subgroup analysis.

    Conclusions:

    • Establishing common reference intervals requires meticulous planning regarding standardization, traceability, and quality control.
    • The strategy for sample collection and analysis significantly impacts the reliability and between-run variation of results.
    • Clear definitions of health and rigorous selection criteria for reference individuals are paramount for valid common reference intervals.