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Related Experiment Videos

Creation of the necessary analytical quality for generating and using reference intervals.

Gerhard Klein1, Wolfgang Junge

  • 1Roche Diagnostics GmbH, Mannheim, Germany. Gerhard.Klein@Roche.com

Clinical Chemistry and Laboratory Medicine
|August 26, 2004
PubMed
Summary

Establishing reliable laboratory medicine reference intervals requires stringent analytical quality. This involves ensuring precision, accuracy, and stability of diagnostic kits across different instruments for accurate patient results.

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Area of Science:

  • Laboratory Medicine
  • Clinical Chemistry
  • Diagnostic Assays

Background:

  • Reference intervals are crucial for interpreting laboratory test results.
  • Analytical quality is a prerequisite for establishing and utilizing reliable reference intervals.
  • Diagnostic kits and their application on various instruments are key components of laboratory testing.

Purpose of the Study:

  • To outline the criteria for analytical quality essential for reference intervals.
  • To differentiate and discuss factors affecting the quality of laboratory methods and their long-term use.
  • To clarify the shared responsibility between manufacturers and users in maintaining analytical quality.

Main Methods:

  • Compilation of criteria for analytical quality in laboratory medicine.

Related Experiment Videos

  • Discussion of factors influencing method and performance quality of diagnostic kits.
  • Examination of factors affecting long-term use quality of laboratory methods.
  • Main Results:

    • Analytical quality is defined by precision, accuracy, and long-term stability of laboratory methods.
    • Quality is categorized into method/performance quality and long-term use quality.
    • Shared responsibility exists between diagnostic kit manufacturers and users for maintaining quality.

    Conclusions:

    • Manufacturers must provide method descriptions and traceability.
    • Users must account for physiological, biometrical, preanalytical, and analytical influences.
    • Adherence to these criteria ensures the integrity and utility of reference intervals.