Traceability in clinical enzymology.

Area of Science:

• Clinical Chemistry
• Biotechnology
• Laboratory Medicine

Background:

• Standardization of enzyme measurements is crucial for comparable results across different laboratories, reagents, and instruments.
• Current methods may yield variable results, impacting clinical decision-making.

Purpose of the Study:

• To describe the reference systems established by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) for enzyme measurements.
• To explain how these systems ensure traceability and comparability of clinical enzyme assay results.

Main Methods:

• Development of reference measurement procedures that are extensively evaluated and described.
• Utilization of certified reference materials.
• Establishment of a network of highly controlled reference laboratories.

Main Results:

• IFCC reference systems enable traceable values to be assigned to commercial calibrators by manufacturers.
• Clinical laboratories can achieve results traceable to higher-order reference procedures using validated calibrators.
• The established traceability chain links routine methods to reference procedures via calibration.

Conclusions:

• IFCC reference systems are essential for achieving standardization in catalytic concentration measurements of clinical enzymes.
• These systems ensure that results from human samples are comparable regardless of the testing environment.
• Traceability is established through a structured approach involving reference procedures, materials, and laboratories.