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Evolution of autoimmune diagnostics over the past 10 years: lessons learned from the UK NEQAS external quality assessment EQA programs

  • Emirena Garrafa , Teresa Carbone , Maria Infantino EMAIL logo , Pierluigi Anzivino , Michela Boni , Sara Ghisellini , Valentina Muraro , Daniele Roselli , Maria Teresa Trevisan , Dina Patel and Nicola Bizzaro
Published/Copyright: January 9, 2025
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 6

Abstract

Objectives

External quality assessment (EQA) programs play a pivotal role in harmonizing laboratory practices, offering users a benchmark system to evaluate their own performance and identify areas requiring improvement. The objective of this study was to go through and analyze the UK NEQAS “Immunology, Immunochemistry and Allergy” EQA reports between 2012 and 2021 to assess the overall level of harmonization in autoimmune diagnostics and identify areas requiring improvement for future actions.

Methods

The EQA programs reviewed included anti-nuclear (ANA), anti-dsDNA, anti-centromere, anti-extractable nuclear antigen (ENA), anti-phospholipids, anti-neutrophil cytoplasm (ANCA), anti-proteinase 3 (PR3), anti-myeloperoxidase (MPO), anti-glomerular basement membrane (GBM), rheumatoid factor (RF), anti-citrullinated protein antibodies (ACPA), mitochondrial (AMA), liver-kidney-microsomal (LKM), smooth muscle (ASMA), APCA, and celiac disease antibodies.

Results

In the analyzed period, the number in participating laboratories showed an increase for almost all programs. Among solid phase methods, the use of ELISA techniques showed a progressive reduction, while new technologies, such as the fluoroenzymatic immunoassay, chemiluminescence immunoassay, Luminex and immunoblot showed an increased number of users. The number of results complying with the expected negative or positive target slightly increased for almost all antibodies in the last decade. A description of the most frequent causes of mistakes or misinterpretation for each specific test and method is also provided in this study.

Conclusions

Although numerous challenges need to be addressed in the area of autoantibody detection to enhance testing quality and attain higher harmonization, the period analyzed revealed that the ever-expanding range of autoantibodies, coupled with the introduction of new tests and methodologies and the advent of automated platforms, has brought about significant changes in autoimmune diagnostics.

Keywords: external quality assessment; harmonization; immunoassays; UK NEQAS
Corresponding author: Maria Infantino, Laboratory of Immunology and Allergy, San Giovanni di Dio Hospital, Florence, Italy, E-mail:
Emirena Garrafa and Teresa Carbone contributed equally to this work.

  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 interests: The authors state no conflict of interest.

  6. Research funding: None declared.

  7. Data availability: Not applicable.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0781).

Received: 2024-07-03
Accepted: 2024-12-15
Published Online: 2025-01-09
Published in Print: 2025-05-26

© 2024 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2024-0781
Keywords for this article
external quality assessment; harmonization; immunoassays; UK NEQAS

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. The Friedewald formula strikes back
  4. Liquid biopsy in oncology: navigating technical hurdles and future transition for precision medicine
  5. The neglected issue of pyridoxal- 5′ phosphate
  6. Reviews
  7. Health literacy: a new challenge for laboratory medicine
  8. Clinical applications of circulating tumor cell detection: challenges and strategies
  9. Opinion Papers
  10. Pleural effusion as a sample matrix for laboratory analyses in cancer management: a perspective
  11. Interest of hair tests to discriminate a tail end of a doping regimen from a possible unpredictable source of a prohibited substance in case of challenging an anti-doping rule violation
  12. Perspectives
  13. Sigma Metrics misconceptions and limitations
  14. EN ISO 15189 revision: EFLM Committee Accreditation and ISO/CEN standards (C: A/ISO) analysis and general remarks on the changes
  15. General Clinical Chemistry and Laboratory Medicine
  16. Evaluation of current indirect methods for measuring LDL-cholesterol
  17. Verification of automated review, release and reporting of results with assessment of the risk of harm for patients: the procedure algorithm proposal for clinical laboratories
  18. Progranulin measurement with a new automated method: a step forward in the diagnostic approach to neurodegenerative disorders
  19. A comparative analysis of current С-peptide assays compared to a reference method: can we overcome inertia to standardization?
  20. Blood samples for ammonia analysis do not require transport to the laboratory on ice: a study of ammonia stability and cause of in vitro ammonia increase in samples from patients with hyperammonaemia
  21. A physio-chemical mathematical model of the effects of blood analysis delay on acid-base, metabolite and electrolyte status: evaluation in blood from critical care patients
  22. Evolution of autoimmune diagnostics over the past 10 years: lessons learned from the UK NEQAS external quality assessment EQA programs
  23. Comparison between monotest and traditional batch-based ELISA assays for therapeutic drug monitoring of infliximab and adalimumab levels and anti-drug antibodies
  24. Evaluation of pre-analytical factors impacting urine test strip and chemistry results
  25. Evaluation of AUTION EYE AI-4510 flow cell morphology analyzer for counting particles in urine
  26. Reference Values and Biological Variations
  27. Estimation of the allowable total error of the absolute CD34+ cell count by flow cytometry using data from UK NEQAS exercises 2004–2024
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  29. Cancer Diagnostics
  30. Tumor specific protein 70 targeted tumor cell isolation technology can improve the accuracy of cytopathological examination
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  33. Infectious Diseases
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