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Supporting prioritization efforts of higher-order reference providers using evidence from the Joint Committee for Traceability in Laboratory Medicine database

  • Mauro Panteghini ORCID logo EMAIL logo and Robert Wielgosz
Published/Copyright: April 11, 2025
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 8

Abstract

The Joint Committee for Traceability in Laboratory Medicine (JCTLM) database represents a valuable resource for implementing metrological traceability in laboratory medicine. Three main database users can be identified: (a) in vitro diagnostic (IVD) manufacturers, using the database information for meeting ISO 17511:2020 requirements, (b) laboratory professionals, for defining the quality of their test results, and (c) providers of higher-order certified reference materials (CRM) and reference measurement procedures (RMP), to be helped in improving the suitability of their products, if needed, and assistance with prioritizing their future efforts. In this report, we focus on the utility of the information provided (or still not provided) by the JCTLM database on this last category of users. Two types of information are discussed: (a) the use of listed CRMs as common calibrators intended to transfer trueness from the top of the calibration hierarchy to commercial IVD calibrators, and (b) the measurement uncertainty (MU) of CRM certified values and the reproducibility characteristics of RMP measurements, considering their impact on the MU of clinical samples, when compared to maximum allowable MU (MAU). The discussion output is a recommendation for suppliers to respond urgently to the need to provide higher-order references (CRMs and/or RMPs) for a number of key analytes that are currently lacking or do not yet fully meet quality criteria related to: (a) commutability assessment, (b) contribution to MAU fulfilment, and (c) demonstration of the extent of equivalence to an already listed higher-order reference.

Keywords: metrological traceability; standardization; patient safety; commutability; measurement uncertainty; analytical performance specifications
Corresponding author: Mauro Panteghini, Department of Laboratory Medicine, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, 9 Sklodowskiej-Curie Street, 85-094 Bydgoszcz, Torun, Poland, E-mail:

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors state no conflict of interest.

  6. Research funding: None declared.

  7. Data availability: Not applicable.

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Received: 2025-03-31
Accepted: 2025-03-31
Published Online: 2025-04-11
Published in Print: 2025-07-28

© 2025 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

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https://doi.org/10.1515/cclm-2025-0401
Keywords for this article
metrological traceability; standardization; patient safety; commutability; measurement uncertainty; analytical performance specifications

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Setting analytical performance specification by simulation (Milan model 1b)
  4. Reviews
  5. Unveiling the power of R: a comprehensive perspective for laboratory medicine data analysis
  6. Clostebol detection after transdermal and transmucosal contact. A systematic review
  7. Opinion Papers
  8. A value-based score for clinical laboratories: promoting the work of the new EFLM committee
  9. Digital metrology in laboratory medicine: a call for bringing order to chaos to facilitate precision diagnostics
  10. Perspectives
  11. Supporting prioritization efforts of higher-order reference providers using evidence from the Joint Committee for Traceability in Laboratory Medicine database
  12. Clinical vs. statistical significance: considerations for clinical laboratories
  13. Genetics and Molecular Diagnostics
  14. Reliable detection of sex chromosome abnormalities by quantitative fluorescence polymerase chain reaction
  15. Targeted proteomics of serum IGF-I, -II, IGFBP-2, -3, -4, -5, -6 and ALS
  16. Candidate Reference Measurement Procedures and Materials
  17. Liquid chromatography tandem mass spectrometry (LC-MS/MS) candidate reference measurement procedure for urine albumin
  18. General Clinical Chemistry and Laboratory Medicine
  19. Patient risk management in laboratory medicine: an international survey to assess the severity of harm associated with erroneous reported results
  20. Exploring the extent of post-analytical errors, with a focus on transcription errors – an intervention within the VIPVIZA study
  21. A survey on measurement and reporting of total testosterone, sex hormone-binding globulin and free testosterone in clinical laboratories in Europe
  22. Quality indicators in laboratory medicine: a 2020–2023 experience in a Chinese province
  23. Impact of delayed centrifugation on the stability of 32 biochemical analytes in blood samples collected in serum gel tubes and stored at room temperature
  24. Concordance between the updated Elecsys cerebrospinal fluid immunoassays and amyloid positron emission tomography for Alzheimer’s disease assessment: findings from the Apollo study
  25. Novel protocol for metabolomics data normalization and biomarker discovery in human tears
  26. Use of the BIOGROUP® French laboratories database to conduct CKD observational studies: a pilot EPI-CKD1 study
  27. Reference Values and Biological Variations
  28. Consensus instability equations for routine coagulation tests
  29. Hematology and Coagulation
  30. Flow-cytometric lymphocyte subsets enumeration: comparison of single/dual-platform method in clinical laboratory with dual-platform extended PanLeucogating method in reference laboratory
  31. Cardiovascular Diseases
  32. Novel Mindray high sensitivity cardiac troponin I assay for single sample and 0/2-hour rule out of myocardial infarction: MERITnI study
  33. Infectious Diseases
  34. Cell population data for early detection of sepsis in patients with suspected infection in the emergency department
  35. Letters to the Editor
  36. Lab Error Finder: A call for collaboration
  37. Cascading referencing of terms and definitions
  38. Strengthening international cooperation and confidence in the field of laboratory medicine by ISO standardization
  39. Determining the minimum blood volume required for laboratory testing in newborns
  40. Performance evaluation of large language models with chain-of-thought reasoning ability in clinical laboratory case interpretation
  41. Vancomycin assay interference: low-level IgM paraprotein disrupts Siemens Atellica® CH VANC assay
  42. Dr. Morley Donald Hollenberg. An extraordinary scientist, teacher and mentor
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