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Diagnostic laboratory tests for systemic autoimmune rheumatic diseases: unmet needs towards harmonization

  • Pier Luigi Meroni EMAIL logo and Maria Orietta Borghi
Published/Copyright: May 1, 2018
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 56 Issue 10

Abstract

Autoantibodies are helpful tools not only for the diagnosis and the classification of systemic autoimmune rheumatic diseases (SARD) but also for sub-grouping patients and/or for monitoring disease activity or specific tissue/organ damage. Consequently, the role of the diagnostic laboratory in the management of SARD is becoming more and more important. The advent of new techniques raised the need of updating and harmonizing our use/interpretation of the assays. We discuss in this opinion paper some of these issues. Indirect immunofluorescence (IIF) was originally suggested as the reference technique for anti-nuclear antibody (ANA) detection as previous solid phase assays (SPA) displayed lower sensitivity. The new available SPA are now offering better results and can represent alternative or even complementary diagnostic tools for ANA detection. The improved sensitivity of SPA technology is also changing our interpretation of the results for other types of autoantibody assays, but we need updating their calibration and new reference materials are going to be obtained in order to harmonize the assays. There is growing evidence that the identification of autoantibody combinations or profiles is helpful in improving diagnosis, patients’ subgrouping and predictivity for disease evolution in the field of SARD. We report some explanatory examples to support the idea to make the use of these autoantibody profiles more and more popular. The technological evolution of the autoimmune assays is going to change our routine diagnostic laboratory tests for SARD and validation of new algorithms is needed in order to harmonize our approach to the issue.

Keywords: autoantibodies; diagnosis; disease sub-grouping; harmonization; predictive value; systemic autoimmune rheumatic diseases
Corresponding author: Prof. Pier Luigi Meroni, Experimental Laboratory of Immunological and Rheumatologic Researches, IRCCS Istituto Auxologico Italiano, Via Zucchi 18, 20095 Cusano Milanino, Milan, Italy, Fax: +39 02 61911 3033

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

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2018-01-18
Accepted: 2018-02-28
Published Online: 2018-05-01
Published in Print: 2018-09-25

©2018 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Harmonization in laboratory medicine: Blowin’ in the wind
  4. Standardization and harmonization of autoimmune diagnostics
  5. On the complexity of hemostasis and the need for harmonization of test practice
  6. Harmonization of laboratory hematology: a long and winding journey
  7. Section 1: Current Harmonization Activities at Global Level
  8. Harmonization in laboratory medicine: more than clinical chemistry?
  9. Harmonization of External Quality Assessment Schemes and their role – clinical chemistry and beyond
  10. An overview of EFLM harmonization activities in Europe
  11. Metrological traceability and harmonization of medical tests: a quantum leap forward is needed to keep pace with globalization and stringent IVD-regulations in the 21st century!
  12. Assessment of bone turnover in osteoporosis: harmonization of the total testing process
  13. Recent initiatives in harmonization of hemostasis practice
  14. EASI – European Autoimmunity Standardisation Initiative: facing the challenges of diagnostics in autoimmunity
  15. Harmonization of microbiology processes and standards: work in progress
  16. Harmonization initiatives in the generation, reporting and application of biological variation data
  17. Harmonization of accreditation to ISO15189
  18. External quality assessment programs in the context of ISO 15189 accreditation
  19. Section 2: Pre-Pre and Pre-Analytical Phase
  20. Laboratory testing in the emergency department: an Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) and Academy of Emergency Medicine and Care (AcEMC) consensus report
  21. The EFLM strategy for harmonization of the preanalytical phase
  22. Section 3: The Analytical Phase
  23. The roadmap for harmonization: status of the International Consortium for Harmonization of Clinical Laboratory Results
  24. The quest for equivalence of test results: the pilgrimage of the Dutch Calibration 2.000 program for metrological traceability
  25. Current state and recommendations for harmonization of serum/plasma 17-hydroxyprogesterone mass spectrometry methods
  26. International normalized ratio (INR) testing in Europe: between-laboratory comparability of test results obtained by Quick and Owren reagents
  27. Detecting molecular forms of antithrombin by LC-MRM-MS: defining the measurands
  28. A design for external quality assessment for the analysis of thiopurine drugs: pitfalls and opportunities
  29. Harmonization of PCR-based detection of intestinal pathogens: experiences from the Dutch external quality assessment scheme on molecular diagnosis of protozoa in stool samples
  30. Harmonization of urine albumin/creatinine ratio (ACR) results: a study based on an external quality assessment program in Polish laboratories
  31. Standardization of autoimmune testing – is it feasible?
  32. Diagnostic laboratory tests for systemic autoimmune rheumatic diseases: unmet needs towards harmonization
  33. Clinically relevant discrepancies between different rheumatoid factor assays
  34. An international survey on anti-neutrophil cytoplasmic antibodies (ANCA) testing in daily clinical practice
  35. Predictive autoimmunity using autoantibodies: screening for anti-nuclear antibodies
  36. Harmonization in autoimmune thyroid disease diagnostics
  37. International consensus on antinuclear antibody patterns: definition of the AC-29 pattern associated with antibodies to DNA topoisomerase I
  38. Reference standards for the detection of anti-mitochondrial and anti-rods/rings autoantibodies
  39. International Consensus on Antinuclear Antibody Patterns: defining negative results and reporting unidentified patterns
https://doi.org/10.1515/cclm-2018-0066
Keywords for this article
autoantibodies; diagnosis; disease sub-grouping; harmonization; predictive value; systemic autoimmune rheumatic diseases

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Harmonization in laboratory medicine: Blowin’ in the wind
  4. Standardization and harmonization of autoimmune diagnostics
  5. On the complexity of hemostasis and the need for harmonization of test practice
  6. Harmonization of laboratory hematology: a long and winding journey
  7. Section 1: Current Harmonization Activities at Global Level
  8. Harmonization in laboratory medicine: more than clinical chemistry?
  9. Harmonization of External Quality Assessment Schemes and their role – clinical chemistry and beyond
  10. An overview of EFLM harmonization activities in Europe
  11. Metrological traceability and harmonization of medical tests: a quantum leap forward is needed to keep pace with globalization and stringent IVD-regulations in the 21st century!
  12. Assessment of bone turnover in osteoporosis: harmonization of the total testing process
  13. Recent initiatives in harmonization of hemostasis practice
  14. EASI – European Autoimmunity Standardisation Initiative: facing the challenges of diagnostics in autoimmunity
  15. Harmonization of microbiology processes and standards: work in progress
  16. Harmonization initiatives in the generation, reporting and application of biological variation data
  17. Harmonization of accreditation to ISO15189
  18. External quality assessment programs in the context of ISO 15189 accreditation
  19. Section 2: Pre-Pre and Pre-Analytical Phase
  20. Laboratory testing in the emergency department: an Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) and Academy of Emergency Medicine and Care (AcEMC) consensus report
  21. The EFLM strategy for harmonization of the preanalytical phase
  22. Section 3: The Analytical Phase
  23. The roadmap for harmonization: status of the International Consortium for Harmonization of Clinical Laboratory Results
  24. The quest for equivalence of test results: the pilgrimage of the Dutch Calibration 2.000 program for metrological traceability
  25. Current state and recommendations for harmonization of serum/plasma 17-hydroxyprogesterone mass spectrometry methods
  26. International normalized ratio (INR) testing in Europe: between-laboratory comparability of test results obtained by Quick and Owren reagents
  27. Detecting molecular forms of antithrombin by LC-MRM-MS: defining the measurands
  28. A design for external quality assessment for the analysis of thiopurine drugs: pitfalls and opportunities
  29. Harmonization of PCR-based detection of intestinal pathogens: experiences from the Dutch external quality assessment scheme on molecular diagnosis of protozoa in stool samples
  30. Harmonization of urine albumin/creatinine ratio (ACR) results: a study based on an external quality assessment program in Polish laboratories
  31. Standardization of autoimmune testing – is it feasible?
  32. Diagnostic laboratory tests for systemic autoimmune rheumatic diseases: unmet needs towards harmonization
  33. Clinically relevant discrepancies between different rheumatoid factor assays
  34. An international survey on anti-neutrophil cytoplasmic antibodies (ANCA) testing in daily clinical practice
  35. Predictive autoimmunity using autoantibodies: screening for anti-nuclear antibodies
  36. Harmonization in autoimmune thyroid disease diagnostics
  37. International consensus on antinuclear antibody patterns: definition of the AC-29 pattern associated with antibodies to DNA topoisomerase I
  38. Reference standards for the detection of anti-mitochondrial and anti-rods/rings autoantibodies
  39. International Consensus on Antinuclear Antibody Patterns: defining negative results and reporting unidentified patterns
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