Recommendations for Setting a Criterion for Assessing Commutability of Secondary Calibrator Certified Reference Materials
Articolo
Data di Pubblicazione:
2023
Citazione:
Recommendations for Setting a Criterion for Assessing Commutability of Secondary Calibrator Certified Reference Materials / W. Greg Miller, T. Keller, J. Budd, J.V. Johansen, M. Panteghini, N. Greenberg, V. Delatour, F. Ceriotti, L. Deprez, R. Rej, J.E. Camara, F. Mackenzie, A.N. Lyle, E. van der Hagen, C. Burns, P. Fauskanger, S. Sandberg. - In: CLINICAL CHEMISTRY. - ISSN 0009-9147. - 69:9(2023), pp. 966-975. [10.1093/clinchem/hvad104]
Abstract:
A secondary higher-order 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). Commutability is a property of a reference material that means results for a reference material and for clinical samples have
the same numeric relationship, within specified limits,
across the measurement procedures for which the reference material is intended to be used. Procedures for assessing commutability have been described in the literature.
This report provides recommendations for establishing a
quantitative criterion to assess the commutability of a certified reference material (CRM).
The criterion is the maximum allowable noncommutability bias (MANCB) that allows a CRM to be used as
a calibrator in a calibration hierarchy for an IVD-MD
without exceeding the maximum allowable combined
standard uncertainty for a clinical sample result
(umaxCS). Consequently, the MANCB is derived as a
fraction of the umaxCS for the measurand. The suitability of an MANCB for practical use in a commutability assessment is determined by estimating the
number of measurements of clinical samples and
CRMs required based on the precision performance
and nonselectivity for the measurand of the
measurement procedures in the assessment. Guidance
is also provided for evaluating indeterminate commutability conclusions and how to report results of a commutability assessment.
Tipologia IRIS:
01 - Articolo su periodico
Elenco autori:
W. Greg Miller, T. Keller, J. Budd, J.V. Johansen, M. Panteghini, N. Greenberg, V. Delatour, F. Ceriotti, L. Deprez, R. Rej, J.E. Camara, F. Mackenzie, A.N. Lyle, E. van der Hagen, C. Burns, P. Fauskanger, S. Sandberg
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