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Quality specifications for reference methods.

L M Thienpont1

  • 1Laboratorium voor Analytische Chemie, Faculteit Farmaceutische Wetenschappen, Universiteit Gent, Belgium. Linda.Thienpont@rug.ac.be

Scandinavian Journal of Clinical and Laboratory Investigation
|February 10, 2000
PubMed
Summary

Establishing analytical quality specifications is crucial for traceability in laboratory medicine. This study proposes strategies for deriving these specifications, distinguishing between essential requirements and adaptable performance limits for reference methods.

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Area of Science:

  • Laboratory Medicine
  • Analytical Chemistry
  • Metrology

Background:

  • Traceability in laboratory medicine relies on robust reference methods.
  • Adequate analytical quality specifications are essential for reference methods to ensure traceability.
  • Existing frameworks for deriving these specifications require refinement.

Purpose of the Study:

  • To present strategies for deriving minimum analytical quality specifications for reference methods.
  • To distinguish between fundamental requirements and performance-based specifications.
  • To advocate for tailored performance specifications based on method application.

Main Methods:

  • Review and adaptation of concepts from a European Working Group.
  • Categorization of requirements into "genuine requirements" and "performance specifications".

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  • Proposal for deriving performance specifications from desirable routine method specifications.

    • Main Results:

    • "Genuine requirements" (e.g., primary calibration, no sample effects) are non-negotiable.
    • "Performance specifications" (error limits) should be variable and application-specific.
    • Deriving performance specifications from routine method targets is generally advocated.

    Conclusions:

    • Reference methods require both fundamental and adaptable quality specifications for effective traceability.
    • Performance specifications should be customized to the intended use of the reference method.
    • Reference laboratories must ensure and demonstrate consistent quality for reference methods.