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Standards versus standardised methods in enzyme assay.

R T Jansen, A P Jansen

    Annals of Clinical Biochemistry
    |January 1, 1983
    PubMed
    Summary
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    Combining enzyme standards with standardized methods significantly improved laboratory consistency for enzyme analysis. This approach reduced interlaboratory variation more effectively than using enzyme standards or standardized methods alone.

    Area of Science:

    • Clinical Chemistry
    • Laboratory Medicine
    • Enzyme Assays

    Background:

    • External and internal quality control programs are crucial for laboratory accuracy.
    • Interlaboratory variation in enzyme measurements can impact patient diagnosis and treatment.
    • Standardization of enzyme assays is essential for reliable clinical chemistry results.

    Purpose of the Study:

    • To compare the effectiveness of different standardization techniques in reducing interlaboratory variation for enzyme analysis.
    • To evaluate the impact of enzyme standards and methodological standardization on the accuracy of enzyme measurements.
    • To determine the optimal standardization strategy for clinical enzyme assays.

    Main Methods:

    • Analysis of control serum and enzyme standards over eight weeks, five times weekly.

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  • Determination of five key enzymes: alkaline phosphatase, creatine kinase, lactate dehydrogenase, alanine aminotransferase, and gamma-glutamyltransferase.
  • Comparison of three standardization approaches: enzyme standards only, methodology standardization only, and a combination of both.
  • Main Results:

    • Methodological standardization alone did not reduce interlaboratory variation compared to using enzyme standards.
    • A combination of methodological standardization and enzyme standards generally yielded the best results, minimizing variation.
    • Specific enzymes like gamma-glutamyltransferase may require substrate standardization in addition to enzyme standards.

    Conclusions:

    • The combined approach of standardizing methodology and using enzyme standards is superior for reducing interlaboratory variation in enzyme testing.
    • The development and use of stable enzyme standards are critical for accurate and consistent laboratory results.
    • Further standardization, including substrate characterization, may be necessary for certain enzymes to achieve optimal assay performance.