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Analytical performance specifications for trace elements in biological fluids derived from six countries federated external quality assessment schemes over 10 years

  • Josiane Arnaud , Cas Weykamp EMAIL logo , Ross Wenzel ORCID logo , Marina Patriarca , Montserrat González-Estecha , Liesbeth Janssen , Ma’atem Beatrice Fofou-Caillierez , Montserrat Ventura Alemany , Valeria Patriarca , Irene de Graaf , Renaud Persoons , Mariona Panadès , Bernard China , Marieke te Winkel , Hans van der Vuurst and Marc Thelen ORCID logo
Published/Copyright: July 22, 2024
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 2

Abstract

Objectives

This article defines analytical performance specifications (APS) for evaluating laboratory proficiency through an external quality assessment scheme.

Methods

Standard deviations for proficiency assessment were derived from Thompson’s characteristic function applied to robust data calculated from participants’ submissions in the Occupational and Environmental Laboratory Medicine (OELM) external quality assurance scheme for trace elements in serum, whole blood and urine. Characteristic function was based on two parameters: (1) β – the average coefficient of variation (CV) at high sample concentrations; (2) α – the average standard deviation (SD) at low sample concentrations. APSs were defined as 1.65 standard deviations calculated by Thompson’s approach. Comparison between OELM robust data and characteristic function were used to validate the model.

Results

Application of the characteristic function allowed calculated APS for 18 elements across three matrices. Some limitations were noted, particularly for elements (1) with no sample concentrations near analytical technique limit of detection; (2) exhibiting high robust CV at high concentration; (3) exhibiting high analytical variability such as whole blood Tl and urine Pb; (4) with an unbalanced number of robust SD above and under the characteristic function such as whole blood Mn and serum Al and Zn.

Conclusions

The characteristic function was a useful means of deriving APS for trace elements in biological fluids where biological variation data or outcome studies were not available. However, OELM external quality assurance scheme data suggests that the characteristic functions are not appropriate for all elements.

Keywords: trace elements; biological fluids; external quality assessment; analytical performance specifications; standard deviation for proficiency assessment
Corresponding author: Cas Weykamp, MCA Laboratory, Queen Beatrix Hospital, Beatrixpark 1, Winterswijk 7101 BN, The Netherlands, E-mail:
The authors are members of the Occupational and Environmental Laboratory Medicine network (OELM) and/or participate in the OELM external quality assessment scheme.

Acknowledgments

The authors would like to thank participating laboratories who submitted their results.

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

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

  4. Competing interests: The authors state no conflict of interest.

  5. Research funding: None declared.

  6. Data availability: Not applicable.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0551).

Received: 2024-05-02
Accepted: 2024-07-07
Published Online: 2024-07-22
Published in Print: 2025-01-29

© 2024 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2024-0551
Keywords for this article
trace elements; biological fluids; external quality assessment; analytical performance specifications; standard deviation for proficiency assessment

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. CD34+ progenitor cells meet metrology
  4. Reviews
  5. Venous blood collection systems using evacuated tubes: a systematic review focusing on safety, efficacy and economic implications of integrated vs. combined systems
  6. The correlation between serum angiopoietin-2 levels and acute kidney injury (AKI): a meta-analysis
  7. Opinion Papers
  8. Advancing value-based laboratory medicine
  9. Clostebol and sport: about controversies involving contamination vs. doping offence
  10. Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement
  11. Perspectives
  12. An improved implementation of metrological traceability concepts is needed to benefit from standardization of laboratory results
  13. Genetics and Molecular Diagnostics
  14. Comparative analysis of BCR::ABL1 p210 mRNA transcript quantification and ratio to ABL1 control gene converted to the International Scale by chip digital PCR and droplet digital PCR for monitoring patients with chronic myeloid leukemia
  15. General Clinical Chemistry and Laboratory Medicine
  16. IVDCheckR – simplifying documentation for laboratory developed tests according to IVDR requirements by introducing a new digital tool
  17. Analytical performance specifications for trace elements in biological fluids derived from six countries federated external quality assessment schemes over 10 years
  18. The effects of drone transportation on routine laboratory, immunohematology, flow cytometry and molecular analyses
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  20. Construction of platelet count-optical method reflex test rules using Micro-RBC#, Macro-RBC%, “PLT clumps?” flag, and “PLT abnormal histogram” flag on the Mindray BC-6800plus hematology analyzer in clinical practice
  21. Evaluation of serum NFL, T-tau, p-tau181, p-tau217, Aβ40 and Aβ42 for the diagnosis of neurodegenerative diseases
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  23. Evaluation of biochemical algorithms to screen dysbetalipoproteinemia in ε2ε2 and rare APOE variants carriers
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