Guidance on Which Calibrators in a Metrologically Traceable Calibration Hierarchy Must Be Commutable with Clinical Samples.
Clin Chem
; 69(3): 228-238, 2023 03 01.
Article
in En
| MEDLINE
| ID: mdl-36660772
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 175112020 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 175112020.
Full text:
1
Database:
MEDLINE
Main subject:
Calibration
Type of study:
Guideline
/
Prognostic_studies
/
Risk_factors_studies
Limits:
Humans
Language:
En
Year:
2023
Type:
Article