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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
Summary
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.
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.