Guidance on Which Calibrators in a Metrologically Traceable Calibration Hierarchy Must Be Commutable with Clinical Samples
| Autor: | W Greg Miller, Neil Greenberg, Mauro Panteghini, Jeffrey R Budd, Jesper V Johansen |
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| Rok vydání: | 2023 |
| Předmět: | |
| Zdroj: | Clinical Chemistry. 69:228-238 |
| ISSN: | 1530-8561 0009-9147 |
| DOI: | 10.1093/clinchem/hvac226 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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