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Related Experiment Video

Updated: Jun 29, 2026

Hot Biological Catalysis: Isothermal Titration Calorimetry to Characterize Enzymatic Reactions
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Setting process control limits for enzyme tests in serum.

J A Lott1

  • 1Department of Pathology, The Ohio State University Medical Center, Columbus 43210, USA. lott.1@osu.edu

Scandinavian Journal of Clinical and Laboratory Investigation
|February 10, 2000
PubMed
Summary
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Performance-based standard deviations for enzyme testing are inappropriate with modern equipment, leading to waste. Laboratories should select control limits that align with clinical needs and available resources.

Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Enzyme Assays

Background:

  • Modern laboratory equipment offers high precision.
  • Current performance-based standard deviations for enzyme testing may be overly rigid.

Purpose of the Study:

  • To evaluate the appropriateness of performance-based standard deviations for enzyme testing.
  • To discuss alternative methods for setting process control limits.

Main Methods:

  • The study reviews current practices in enzyme testing and precision limits.
  • It considers the clinical utility of enzyme data and laboratory resources.

Main Results:

  • Performance-based standard deviations are not suitable for current enzyme testing precision.

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  • Existing methods for setting control limits have arbitrary elements but remain usable.
  • Tight precision is often unnecessary for common serum enzyme tests.

    • Conclusions:

    • Laboratories should move away from overly rigid, performance-based standard deviations for enzyme testing.
    • The choice of process control limits should be tailored to laboratory capabilities and clinical requirements.
    • Selecting appropriate control limits ensures efficient resource use and meets medical needs.