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Method comparison in the clinical laboratory.

Asger Lundorff Jensen1, Mads Kjelgaard-Hansen

  • 1Department of Small Animal Clinical Science, The Royal Veterinary and Agricultural University, Groennegaardsvej 3, DK-1870, Frederiksberg C, Denmark. alj@kvl.dk

Veterinary Clinical Pathology
|September 13, 2006
PubMed
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This review details a 9-step protocol for comparing new clinical laboratory methods with established ones. It provides objective criteria for assessing analytical error and ensuring measurement comparability.

Area of Science:

  • Clinical Pathology
  • Laboratory Medicine
  • Analytical Chemistry

Background:

  • Method comparison studies are crucial in clinical laboratories to validate new diagnostic tools.
  • Assessing analytical error (total, random, systematic) is key to ensuring measurement comparability.
  • Established methods serve as benchmarks for evaluating novel analytical techniques.

Purpose of the Study:

  • To describe types of analytical errors assessable in method comparison.
  • To recommend a general 9-step protocol for comparing quantitative methods.
  • To provide a framework for objectively evaluating new laboratory methods.

Main Methods:

  • A 9-step protocol is proposed, covering experimental design, error estimation, sample analysis, and data interpretation.

Related Experiment Videos

  • Statistical methods for analyzing paired results are discussed.
  • Decision criteria for judging method acceptability are recommended.

    • Main Results:

    • The protocol facilitates objective assessment of a new method's analytical performance against a reference method.
    • Examples illustrate the protocol's application, including comparing alanine aminotransferase assays.
    • A protocol for semiquantitative method comparison is also suggested.

    Conclusions:

    • The recommended protocol offers a structured approach to method comparison in clinical pathology.
    • Objective evaluation of analytical performance ensures reliable diagnostic measurements.
    • The protocol aids in making informed decisions about adopting new laboratory methods.