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The evolving role of commutability in metrological traceability
W Greg Miller1, Neil Greenberg2, Jeffry Budd3
1Virginia Commonwealth University, Richmond, VA, USA.
Clinica Chimica Acta; International Journal of Clinical Chemistry
|December 28, 2020
Summary
Commutability ensures reference materials (RMs) behave like clinical samples in lab tests. This property is crucial for accurate, traceable results across different measurement procedures (MPs).
Area of Science:
- Laboratory Medicine
- Metrology
- Analytical Chemistry
Background:
- Commutability is key for reference materials (RMs) to ensure accurate lab test results.
- Matrix-based secondary calibrators must be commutable with clinical samples for metrological traceability.
- Noncommutable RMs can lead to discrepancies in results across different measurement procedures (MPs).
Purpose of the Study:
- To highlight the critical role of commutability in metrological traceability.
- To present recommendations from IFCC Working Groups on commutability.
- To discuss the impact of RM production modifications on commutability.
Main Methods:
- The study reviews the definition and importance of commutability in laboratory medicine.
- It examines how modifications during RM production can affect commutability.
- It discusses the regulatory requirements for commutability documentation.
Main Results:
- Commutability ensures analytical responses are consistent between reference materials and clinical samples.
- Noncommutable RMs can introduce bias, affecting result agreement among different measurement procedures.
- Corrections for noncommutability bias can be applied to maintain metrological traceability.
Conclusions:
- Commutability is a fundamental property for RMs used as calibrators in laboratory medicine.
- Ensuring commutability is essential for achieving reliable and comparable results from clinical laboratory measurement procedures.
- Standardization bodies require documentation of commutability for matrix-based RMs.
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