Recommendations for setting a criterion and assessing commutability of sample materials used in external quality assessment/proficiency testing schemes

Published

November 2, 2023

Author(s)

Sverre Sandberg, Pernille Fauskanger, Jesper Johansen, Thomas Keller, Jeffrey Budd, Neil Greenberg, robert rej, MAURO PANTEGHINI, VINCENT DELATOUR, Ferruccio Ceriotti, Liesbet Deprez, Johanna Camara, Finlay MacKenzie, Alicia Lyle, Eline van der Hagen, Chris Burns, W. Greg Miller

Abstract

It is important for external quality assessment materials (EQAMs) to be commutable with clinical samples; i.e., they should behave like clinical samples when measured using end-user clinical laboratory in vitro diagnostic medical devices (IVD-MDs). Using commutable EQAMs makes it possible to evaluate metrological traceability and/or equivalence of results between IVD-MDs. The criterion for assessing commutability of an EQAM between 2 IVD-MDs is that its result should be within the prediction interval limits based on the statistical distribution of the clinical sample results from the 2 IVD-MDs being compared. The width of the prediction interval is, among other things, dependent on the analytical performance characteristics of the IVD-MDs. A presupposition for using this criterion is that the differences in nonselectivity between the 2 IVD-MDs being compared are acceptable. An acceptable difference in nonselectivity should be small relative to the analytical performance specifications used in the external quality assessment scheme. The acceptable difference in nonselectivity is used to modify the prediction interval criterion for commutability assessment. The present report provides recommendations on how to establish a criterion for acceptable commutability for EQAMS, establish the difference in nonselectivity that can be accepted between IVD-MDs, and perform a commutability assessment. The report also contains examples for performing a commutability assessment of EQAMs.

Citation

Clinical Chemistry

Volume

69

Issue

11

Pub Type

Journals

Download Paper

https://doi.org/10.1093/clinchem/hvad135

Local Download

Keywords

Commutability, commutability criterion, external quality assessment, proficiency testing

Citation

Sandberg, S. , Fauskanger, P. , Johansen, J. , Keller, T. , Budd, J. , Greenberg, N. , Rej, R. , Panteghini, M. , Delatour, V. , Ceriotti, F. , Deprez, L. , Camara, J. , MacKenzie, F. , Lyle, A. , van der Hagen, E. , Burns, C. and Miller, W. (2023), Recommendations for setting a criterion and assessing commutability of sample materials used in external quality assessment/proficiency testing schemes, Clinical Chemistry, [online], https://doi.org/10.1093/clinchem/hvad135, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=936663 (Accessed December 4, 2024)