Guidance on Which Calibrators in a Metrologically Traceable Calibration Hierarchy Must Be Commutable with Clinical Samples
Articolo
Data di Pubblicazione:
2023
Citazione:
Guidance on Which Calibrators in a Metrologically Traceable Calibration Hierarchy Must Be Commutable with Clinical Samples / W. Greg Miller, N. Greenberg, M. Panteghini, J.R. Budd, J.V. Johansen. - In: CLINICAL CHEMISTRY. - ISSN 0009-9147. - 69:3(2023), pp. 228-238. [10.1093/clinchem/hvac226]
Abstract:
Equivalent results for the same measurand in clinical samples (CSs), measured using different end-user in-vitro diagnostic medical devices (IVD-MDs), are essential for the application of clinical practice guidelines for diagnosis, treatment, monitoring, or risk assessment. The International Organization for Standardization (ISO) document 17511:2020 specifies how to establish metrological traceability to the highest available reference system component to enable equivalent results among IVD-MDs. Commutability with CSs is an essential property of a reference material used as a calibrator in a calibration hierarchy. However, not all calibrators in a calibration hierarchy are required to be commutable; different calibration hierarchies have different requirements for which calibrators must be commutable with CSs. Because assessment of commutability is a substantial effort, it is therefore important to determine which calibrators need to be commutable when implementing a calibration hierarchy. We provide guidance on which calibrators must be commutable with CSs, when a correction for any noncommutability bias is appropriate, and when commutability of a calibrator with CSs is not required for various types of calibration hierarchies described in ISO 17511:2020.
Tipologia IRIS:
01 - Articolo su periodico
Elenco autori:
W. Greg Miller, N. Greenberg, M. Panteghini, J.R. Budd, J.V. Johansen
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