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[Enzyme calibrators: principle and practical use].

J M Lessinger1, F Schiele, A Vialle

  • 1Laboratoire du CTO et Laboratoire de biochimie appliquée, Université Louis-Pasteur de Strasbourg, 10, avenue Baumann, 67401 Illkirch.

Annales De Biologie Clinique
|June 7, 2002
PubMed
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Validated enzyme calibrators significantly improve interlaboratory comparability in clinical enzymology. Using common calibrators reduced variability for enzymes like ALT and gammaGT to nearly 4%.

Area of Science:

  • Biochemistry
  • Clinical Chemistry
  • Enzymology

Context:

  • Enzyme activity measurements in clinical enzymology suffer from poor interlaboratory comparability due to variations in procedures and local conditions.
  • Standardized operating procedures (SOPs) and validated enzyme calibrators have been proposed by SFBC and IFCC to address this issue.
  • IFCC has developed standardized SOPs for common clinical chemistry enzymes, adapted for 37°C, which are nearing publication.

Purpose:

  • To evaluate the effectiveness of validated enzyme calibrators in improving interlaboratory comparability for enzyme activity measurements.
  • To assess whether calibrating different measurement methods with a common calibrator enhances result consistency.
  • To investigate the commutability of reference materials when used as calibrators across various analytical specificities.

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Summary:

  • Standardized operating procedures (SOPs) adapted to 37°C have been developed by IFCC for key clinical chemistry enzymes.
  • Reference materials certified using these SOPs can serve as validated enzyme calibrators if they are commutable across methods with similar analytical specificity.
  • Studies demonstrated that using a common calibrator significantly improved interlaboratory comparability, achieving a coefficient of variation (CV) close to 4% for ALT and gammaGT, unlike comparing results to reference range limits.

Impact:

  • The use of validated enzyme calibrators offers a viable solution to enhance the reliability and consistency of enzyme activity measurements across different laboratories.
  • This approach facilitates more accurate clinical diagnoses and treatment monitoring by reducing variability in diagnostic test results.
  • The development and implementation of standardized calibrators and SOPs are crucial for advancing the field of clinical enzymology and ensuring patient safety.