Optimizing Available Tools for Obtaining Result Standardization: A Joint Committee on Traceability in Laboratory Medicine (JCTLM) Project

Published

October 12, 2021

Author(s)

Mauro Panteghini, Federica Braga, Johanna Camara, Vincent Delatour, Katleen Van Uytfanghe, Hubert Vesper, Tianjiao Zhang

Abstract

BACKGROUND: The JCTLM created a Task Force on Reference Measurement System Implementation (TFRMSI) to provide guidance on metrological traceability implementation for the in vitro diagnostics (IVD) community. CONTENT: TF-RMSI investigated the reference measurement systems (RMS) for 13 common measurands by applying the following procedural steps: (a) extracting data from the JCTLM database of available certified reference materials (CRMs) and reference measurement procedures (RMPs); (b) describing the RMS to which each recruited CRM or RMP belongs; (c) identifying the intended use of the CRMs, and, if used as a common calibrator for IVD measuring systems and/or trueness assessment of field methods was included, checking the CRM's certificate for information about commutability with clinical samples; and (d) checking if the CRM or RMP measurement uncertainty (MU) has the potential to be small enough to avoid significantly affecting the analytical performance specifications (APS) for MU of clinical sample results when the MU from the IVD calibrator and from the end-user measuring system were combined. SUMMARY: We produced a synopsis of JCTLM-listed higher-order CRMs and RMPs for the selected measurands, including their main characteristics for implementing traceability and fulfilling (or not) the APS for suitable MU. Results showed that traceability to higher-order references can be established by IVD manufacturers within the defined APS for most of the 13 selected measurands. However, some measurands do not yet have suitable CRMs for use as common calibrators. For these measurands, splitting clinical samples with a laboratory performing the RMP may provide a practical alternative for establishing a calibration hierarchy.

Citation

Clinical Chemistry

Pub Type

Journals

Download Paper

https://doi.org/10.1093/clinchem/hvab178

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Keywords

standardization, laboratory medicine, certified reference materials, reference measurement procedures, traceability

Citation

Panteghini, M. , Braga, F. , Camara, J. , Delatour, V. , Van Uytfanghe, K. , Vesper, H. and Zhang, T. (2021), Optimizing Available Tools for Obtaining Result Standardization: A Joint Committee on Traceability in Laboratory Medicine (JCTLM) Project, Clinical Chemistry, [online], https://doi.org/10.1093/clinchem/hvab178, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=932332 (Accessed October 8, 2025)