Recommendations for Setting a Criterion for Assessing Commutability of Secondary Calibrator Certified Reference Materials
Commutability is a property of a reference material such that the reference material has the same measurement response between two or more measurement procedures as observed for clinical samples. A matrix-based secondary calibrator is required to be commutable with clinical samples to be suitable for use in the calibration hierarchy of an end-user clinical laboratory in vitro diagnostic medical device (IVD-MD). Procedures for assessing commutability have been described in the literature. This report provides recommendations for establishing a criterion to assess the commutability of matrix-based secondary calibrator certified reference materials (CRMs).
The criterion is the maximum allowable noncommutability bias (MANCB) that permits a CRM to be used in calibration hierarchies with that MANCB allowing the IVD-MD to meet the analytical performance specification for the maximum allowable combined standard uncertainty for a clinical sample (MAuCS) result for the measurand. Consequently, the MANCB is derived as a fraction of the MAuCS for the measurand. Once a MANCB is determined, it can be assessed for practical use in a commutability assessment by estimating the number of measurements of clinical samples and CRMs required given the intermediate precision performance and an estimate of any non-selectivity for the measurand of the measuring systems included in the commutability assessment.
MILLER W. Greg;
KELLER Thomas;
BUDD Jeffrey;
JOHANSEN Jesper V.;
PANTEGHINI M.;
GREENBERG Neel;
DELATOUR Vincent;
CERIOTTI Ferruccio;
DEPREZ Liesbet;
REJ Robert;
CAMARA Johanna E;
MÀCKENZIE Finlay;
LYLE Alicia;
VAN DER HAGEN Elina;
BURNS Chris;
FAUSKANGER Pernille;
SANDBERG Sverre;
2023-11-21
OXFORD UNIV PRESS INC
JRC133257
0009-9147 (online),
https://doi.org/10.1093/clinchem/hvad104,
https://publications.jrc.ec.europa.eu/repository/handle/JRC133257,
10.1093/clinchem/hvad104 (online),
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