Result harmonization in medical laboratories: accomplishments and challenges.

Published

March 13, 2026

Author(s)

Tony Badrick, Ralf D. Josephs, Liesbet Deprez, Christa Cobbaert, VINCENT DELATOUR, Christian Vogl, Katleen Van Uytfanghe, Ashley Green, Sverre Sandberg

Abstract

The Joint Committee for Traceability in Laboratory Medicine was established in 2002 in response to the implementation of the European Community Directive 98.79/EC on in vitro medical devices. The Committee consisted of representatives from the International Bureau of Weights and Measures (BIPM), the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), and the International Laboratory Accreditation Cooperation (ILAC). The primary output of the JCTLM is a global database of higher-order reference materials, reference measurement methods/procedures, and reference measurement services. All references listed in the database are reviewed for conformance to applicable ISO standards. The role of JCTLM is to support worldwide equivalence and comparability of measurement results in laboratory medicine, for the purpose of improving health care, and facilitating national and international trade in in-vitro diagnostic (IVD) medical devices, by (1): • promoting the concept of traceability of measurement results to the Système International d'Unités (SI) or, where necessary, to other internationally agreed references. • evaluating reference materials, reference measurement procedures and reference measurement services for laboratory medicine for conformity with appropriate international standards. • producing educational materials and activities promoting the value of traceability in laboratory medicine and raising awareness amongst stakeholders. • promoting close links between Reference Laboratories in Laboratory Medicine and National Metrology Institutes. • facilitating the identification and prioritization of measurands requiring international traceability and equivalence and thereby encouraging appropriate organizations to accept responsibility for the development of suitable reference measurement procedures and certified reference materials. • encouraging the IVD industry to apply the agreed reference measurement systems. • encouraging External Quality Assessment (EQA) organizers to apply reference measurement procedure values to commutable EQA materials. The JCTLM organizes a biennial meeting for its members and stakeholders. The 2025 workshop focused on the expectations and benefits of harmonized results among medical laboratories, as well as the challenges associated with achieving this goal. The necessary initiatives for Reference Materials, Procedures, and Services, along with the challenges in providing these in compliance with relevant ISO standards and sustaining these reference systems, as well as descriptions of where these systems are located. The process of implementing traceability by IVD manufacturers was discussed, as well as its impact on various regional regulatory requirements in the international market, and the opportunities offered by new processes for harmonizing measurement results.

Citation

Clinical Chemistry and Laboratory Medicine

Volume

64

Issue

6

Pub Type

Journals

Download Paper

https://doi.org/10.1515/cclm-2026-0323

Local Download

Keywords

Metrologoical Traceability, Reference Materials, Referecen Measurement Procedure

Citation

Badrick, T. , Josephs, R. , Deprez, L. , Cobbaert, C. , Delatour, V. , Vogl, C. , Van Uytfanghe, K. , Green, A. and Sandberg, S. (2026), Result harmonization in medical laboratories: accomplishments and challenges., Clinical Chemistry and Laboratory Medicine, [online], https://doi.org/10.1515/cclm-2026-0323, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=961338 (Accessed July 21, 2026)

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