The evolving role of commutability in metrological traceability.

Commutability is a property of a reference material (RM) which denotes that the analytical response in measurement procedures (MPs) observed for the measurand is the same for the RM as for clinical samples that contain the same amount of the measurand. Matrix-based secondary calibrators are required to be commutable with clinical samples to achieve metrological traceability of results from a clinical laboratory MP to higher order references. Results for clinical samples may not agree among different end-user MPs if a noncommutable RM is used in the calibration hierarchy for one or more of the MPs. Consequently, a useful RM is one that is commutable with clinical samples for all or most MPs in common use. If a matrix-based RM is noncommutable for one or a few MPs, a correction for the noncommutability bias may be added in the calibration hierarchy to enable the results for clinical samples to be metrologically traceable to the RM. Producing a large batch of matrix-based RM requires pooling single donations and making various modifications of the matrix such as spiking with exogenous substances, freezing or lyophilization. These modifications could potentially affect commutability of the RM and compromise its suitability. Documentation of commutability of matrix-based RMs used as calibrators is required by the International Organization for Standardization and the Joint Committee for Traceability in Laboratory Medicine. We describe how commutability was recognized as a critical requirement for metrological traceability and we present recommendations from the IFCC Working Groups on Commutability and on Commutability in Metrological Traceability.