Abstract
In this review we analyze all aspects of total testing process regarding the measurement of antithyroid peroxidase, antithyroglobulin and antithyrotropin receptor autoantibodies. The main critical points related to the preanalytical, analytical and postanalytical steps of autoimmune thyroid disease diagnostics are considered, focusing on harmonization of autoimmune thyroid tests request, retesting intervals, terminology of thyroid autoantibodies, measurement units and definition of reference limits. Harmonization in thyroid autoantibody testing is a relevant example of feasible harmonization in autoimmunology.
References
1. Plebani M, Laposata M, Lundberg GD. The brain-to-brain loop concept for laboratory testing 40 years after its introduction. Am J Clin Pathol 2011;136:829–33.10.1309/AJCPR28HWHSSDNONSuche in Google Scholar PubMed
2. Aarsand AK, Sandberg S. How to achieve harmonization of laboratory testing-the complete picture. Clin Chim Acta 2014;432:8–14.10.1016/j.cca.2013.12.005Suche in Google Scholar PubMed
3. Tate JR, Johnson R, Sikaris K. Harmonization of laboratory testing. Clin Biochem Rev 2012;33:121–2.Suche in Google Scholar
4. Plebani M. Harmonization in laboratory medicine: requests, samples, measurements and reports. Crit Rev Clin Lab Sci 2016;53:184–96.10.3109/10408363.2015.1116851Suche in Google Scholar PubMed
5. Thienpont LM, Faix JD, Beastall G. Standardization of FT4 and harmonization of TSH – a request for imput from endocrinologists and other physicians. Endocr Pract 2016;22:374.10.4158/1934-2403-22.3.374Suche in Google Scholar PubMed
6. Clerico A, Ripoli A, Fortunato A, Alfano A, Carrozza C, Correale M, et al. Harmonization protocols for TSH immunoassays: a multicenter study in Italy. Clin Chem Lab Med 2017;55:1722–33.10.1515/cclm-2016-0899Suche in Google Scholar PubMed
7. Faix JD, Miller WG. Progress in standardizing and harmonizing thyroid function tests. Am J Clin Nutr 2016;104(Suppl):913S–7S.10.3945/ajcn.115.110379Suche in Google Scholar PubMed PubMed Central
8. Frohlich E, Wahl R. Thyroid autoimmunity: role of anti-thyroid antibodies in thyroid and extra-thyroidal diseases. Front Immunol 2017;8:521.10.3389/fimmu.2017.00521Suche in Google Scholar PubMed PubMed Central
9. Caturegli P, De Remigis A, Rose NR. Hashimoto thyroiditis: clinical and diagnostic criteria. Autoimmun Rev 2014;13:391–7.10.1016/j.autrev.2014.01.007Suche in Google Scholar PubMed
10. D’Aurizio F, Tozzoli R, Villalta D, Pesce G, Bagnasco M. Immunoassay of thyroid peroxidase autoantibodies: diagnostic performance in automated third generation methods. A multicenter evaluation. Clin Chem Lab Med 2015;53:415–21.10.1515/cclm-2014-0545Suche in Google Scholar PubMed
11. Singh I, Hershman JM. Pathogenesis of hyperthyroidism. Compr Physiol 2017;7:67–79.10.1002/cphy.c160001Suche in Google Scholar PubMed
12. Tozzoli R, Bizzaro N, Tonutti E, Pradella M, Manoni F, Vilalta D, et al. Immunoassay of anti-thyroid antibodies: high analytical variability in second generation methods. Clin Chem Lab Med 2002;40:568–73.10.1515/CCLM.2002.098Suche in Google Scholar PubMed
13. Tozzoli R, Villalta D, Bizzaro N. Challenges in the standardization of autoantibody testing: A comprehensive review. Clin Rev Allerg Immunol 2017;53:68–77.10.1007/s12016-016-8579-ySuche in Google Scholar PubMed
14. Plebani M. Harmonization in laboratory medicine: more than clinical chemistry? Clin Chem Lab Med 2018;56:1579–86.10.1515/cclm-2017-0865Suche in Google Scholar PubMed
15. Fryer AA, Smellie WS. Managing demand for laboratory tests: a laboratory toolkit. J Clin Pathol 2013;66:62–72.10.1136/jclinpath-2011-200524Suche in Google Scholar PubMed
16. Baloch Z, Carayon P, Comte-Devolx B, Demers LM, Feldt-Rasmussen U, Henry JF, et al. Laboratory medicine practice guidelines. Laboratory support for the diagnosis and monitoring of thyroid disease. Thyroid 2003;13:3–126.10.1089/105072503321086962Suche in Google Scholar PubMed
17. Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, et al. 2015 American Thyroid Association management guidelines for adult patients with thyroid nodules and differentiated thyroid cancer. Thyroid 2016;26:1–133.10.1089/thy.2015.0020Suche in Google Scholar PubMed PubMed Central
18. Trimboli P, Zilioli V, Imperiali M, Giovanella L. Thyroglobulin antibodies before radioiodine ablation predict differentiated thyroid cancer outcome. Clin Chem Lab Med 2017;55:1995–2001.10.1515/cclm-2017-0033Suche in Google Scholar PubMed
19. Tozzoli R, Bagnasco M, Giavarina D, Bizzaro N. TSH receptor autoantibody immunoassay in patients with Graves’ disease: improvement of diagnostic accuracy over different generation of methods. Systematic review and meta-analysis. Autoimmun Rev 2013;12:107–13.10.1016/j.autrev.2012.07.003Suche in Google Scholar PubMed
20. Hollowell JG, Staehling NW, Flanders WD, Hannon WH, Gunter EW, Spencer CA, et al. Serum TSH, T(4), and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab 2002;87:489–99.10.1210/jcem.87.2.8182Suche in Google Scholar PubMed
21. Shyamasunder AH, Abraham P. Measuring TSH receptor antibody to influence treatment choices in Graves’ disease. Clin Endocrinol 2017;86:652–7.10.1111/cen.13327Suche in Google Scholar PubMed
22. Morshed SA, Davies TF. Graves’ disease mechanisms: the role of stimulating, blocking, and cleavage region TSH receptor antibodies. Horm Metab Res 2015;47:727–34.10.1055/s-0035-1559633Suche in Google Scholar PubMed PubMed Central
23. Frank CU, Braeth S, Dietrich JW, Wanjura D, Loos U. Bridge technology with TSH receptor chimera for sensitive direct detection of TSH receptor antibodies causing Graves’ disease: analytical and clinical evaluation. Horm Metab Res 2015;47:880–8.10.1055/s-0035-1554662Suche in Google Scholar PubMed
24. Tozzoli R, D’Aurizio F, Villalta D, Giovanella L. Evaluation of the first fully automated immunoassay method for the measurement of stimulating TSH receptor autoantibodies in Graves’ disease. Clin Chem Lab Med 2017;55:58–64.10.1515/cclm-2016-0197Suche in Google Scholar PubMed
25. Tozzoli R. The increasing clinical relevance of TSH receptor autoantibodies and the concurrent evolution of assay methods in autoimmune hyperthyroidism. J Lab Prec Med 2018. Accepted for publication.10.21037/jlpm.2018.03.05Suche in Google Scholar
26. Plebani M. Harmonization of clinical laboratory information – current and future strategies. EJIFCC 2016;27:15–22.Suche in Google Scholar
27. D’Aurizio F, Metus P, Ferrari A, Caruso B, Castello R, Villalta D, et al. Definition of the upper reference limit for thyroglobulin antibodies according to the National Academy of Clinical Biochemistry guidelines: comparison of eleven different automated methods. Auto Immun Highlights 2017;8:8.10.1007/s13317-017-0096-3Suche in Google Scholar PubMed PubMed Central
28. D’Aurizio F, Metus P, Polizzi Anselmo A, Villalta D, Ferrari A, Castello R, et al. Establishment of the upper reference limit for thyroid peroxidase autoantibodies according to the guidelines proposed by the National Academy of Clinical Biochemistry: comparison of five different automated methods. Auto Immun Highlights 2015;6:31–7.10.1007/s13317-015-0070-xSuche in Google Scholar PubMed PubMed Central
29. Tozzoli R, D’Aurizio F, Ferrari A, Castello R, Metus P, Caruso B, et al. The upper reference limit for thyroid peroxidase antibodies is method-dependent: a collaborative study with biochemical industries. Clin Chim Acta 2016;452:61–5.10.1016/j.cca.2015.10.025Suche in Google Scholar PubMed
30. Villalta D, D’Aurizio F, Da Re M, Ricci D, Latrofa F, Tozzoli R. Diagnostic accuracy of a new fluoroenzyme immunoassay for the detection of TSH receptor autoantibodies in Graves’ disease. Auto Immun Highlights 12 Feb 2018; doi: 10.1007/s13317-018-0102-4. [Epub ahead of print].10.1007/s13317-018-0102-4Suche in Google Scholar PubMed PubMed Central
31. Armbruster D, Donnelly J. Harmonization of clinical laboratory results: the role of the IVD industry. EJIFCC 2016;27:37–47.Suche in Google Scholar
32. Ichihara K. Statistical considerations for harmonization of the global multicenter study on reference values. Clin Chim Acta 2014;432:108–18.10.1016/j.cca.2014.01.025Suche in Google Scholar PubMed
33. Moore GW. Recent guidelines and recommendations for laboratory detection of lupus anticoagulants. Semin Thromb Hemost 2014;40:163–71.10.1055/s-0033-1364185Suche in Google Scholar PubMed
34. Damoiseaux J, von Muhlen CA, Garcia-De La Torre I, Carbalho OG, de Melo Curvinel W, Francescantonio PL, et al. International consensus on ANA patterns (ICAP): the bumpy road towards a consensus on reporting ANA results. Auto Immun Highlights 2016;7:1.10.1007/s13317-016-0075-0Suche in Google Scholar PubMed PubMed Central
35. Favaloro EJ, Plebani M, Lippi G. Standardization and harmonization of antiphospholipids antibody assays. Semin Thromb Hemost 2014;40:161–2.10.1055/s-0033-1364184Suche in Google Scholar PubMed
©2018 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Frontmatter
- Editorials
- Harmonization in laboratory medicine: Blowin’ in the wind
- Standardization and harmonization of autoimmune diagnostics
- On the complexity of hemostasis and the need for harmonization of test practice
- Harmonization of laboratory hematology: a long and winding journey
- Section 1: Current Harmonization Activities at Global Level
- Harmonization in laboratory medicine: more than clinical chemistry?
- Harmonization of External Quality Assessment Schemes and their role – clinical chemistry and beyond
- An overview of EFLM harmonization activities in Europe
- 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!
- Assessment of bone turnover in osteoporosis: harmonization of the total testing process
- Recent initiatives in harmonization of hemostasis practice
- EASI – European Autoimmunity Standardisation Initiative: facing the challenges of diagnostics in autoimmunity
- Harmonization of microbiology processes and standards: work in progress
- Harmonization initiatives in the generation, reporting and application of biological variation data
- Harmonization of accreditation to ISO15189
- External quality assessment programs in the context of ISO 15189 accreditation
- Section 2: Pre-Pre and Pre-Analytical Phase
- 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
- The EFLM strategy for harmonization of the preanalytical phase
- Section 3: The Analytical Phase
- The roadmap for harmonization: status of the International Consortium for Harmonization of Clinical Laboratory Results
- The quest for equivalence of test results: the pilgrimage of the Dutch Calibration 2.000 program for metrological traceability
- Current state and recommendations for harmonization of serum/plasma 17-hydroxyprogesterone mass spectrometry methods
- International normalized ratio (INR) testing in Europe: between-laboratory comparability of test results obtained by Quick and Owren reagents
- Detecting molecular forms of antithrombin by LC-MRM-MS: defining the measurands
- A design for external quality assessment for the analysis of thiopurine drugs: pitfalls and opportunities
- Harmonization of PCR-based detection of intestinal pathogens: experiences from the Dutch external quality assessment scheme on molecular diagnosis of protozoa in stool samples
- Harmonization of urine albumin/creatinine ratio (ACR) results: a study based on an external quality assessment program in Polish laboratories
- Standardization of autoimmune testing – is it feasible?
- Diagnostic laboratory tests for systemic autoimmune rheumatic diseases: unmet needs towards harmonization
- Clinically relevant discrepancies between different rheumatoid factor assays
- An international survey on anti-neutrophil cytoplasmic antibodies (ANCA) testing in daily clinical practice
- Predictive autoimmunity using autoantibodies: screening for anti-nuclear antibodies
- Harmonization in autoimmune thyroid disease diagnostics
- International consensus on antinuclear antibody patterns: definition of the AC-29 pattern associated with antibodies to DNA topoisomerase I
- Reference standards for the detection of anti-mitochondrial and anti-rods/rings autoantibodies
- International Consensus on Antinuclear Antibody Patterns: defining negative results and reporting unidentified patterns
Artikel in diesem Heft
- Frontmatter
- Editorials
- Harmonization in laboratory medicine: Blowin’ in the wind
- Standardization and harmonization of autoimmune diagnostics
- On the complexity of hemostasis and the need for harmonization of test practice
- Harmonization of laboratory hematology: a long and winding journey
- Section 1: Current Harmonization Activities at Global Level
- Harmonization in laboratory medicine: more than clinical chemistry?
- Harmonization of External Quality Assessment Schemes and their role – clinical chemistry and beyond
- An overview of EFLM harmonization activities in Europe
- 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!
- Assessment of bone turnover in osteoporosis: harmonization of the total testing process
- Recent initiatives in harmonization of hemostasis practice
- EASI – European Autoimmunity Standardisation Initiative: facing the challenges of diagnostics in autoimmunity
- Harmonization of microbiology processes and standards: work in progress
- Harmonization initiatives in the generation, reporting and application of biological variation data
- Harmonization of accreditation to ISO15189
- External quality assessment programs in the context of ISO 15189 accreditation
- Section 2: Pre-Pre and Pre-Analytical Phase
- 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
- The EFLM strategy for harmonization of the preanalytical phase
- Section 3: The Analytical Phase
- The roadmap for harmonization: status of the International Consortium for Harmonization of Clinical Laboratory Results
- The quest for equivalence of test results: the pilgrimage of the Dutch Calibration 2.000 program for metrological traceability
- Current state and recommendations for harmonization of serum/plasma 17-hydroxyprogesterone mass spectrometry methods
- International normalized ratio (INR) testing in Europe: between-laboratory comparability of test results obtained by Quick and Owren reagents
- Detecting molecular forms of antithrombin by LC-MRM-MS: defining the measurands
- A design for external quality assessment for the analysis of thiopurine drugs: pitfalls and opportunities
- Harmonization of PCR-based detection of intestinal pathogens: experiences from the Dutch external quality assessment scheme on molecular diagnosis of protozoa in stool samples
- Harmonization of urine albumin/creatinine ratio (ACR) results: a study based on an external quality assessment program in Polish laboratories
- Standardization of autoimmune testing – is it feasible?
- Diagnostic laboratory tests for systemic autoimmune rheumatic diseases: unmet needs towards harmonization
- Clinically relevant discrepancies between different rheumatoid factor assays
- An international survey on anti-neutrophil cytoplasmic antibodies (ANCA) testing in daily clinical practice
- Predictive autoimmunity using autoantibodies: screening for anti-nuclear antibodies
- Harmonization in autoimmune thyroid disease diagnostics
- International consensus on antinuclear antibody patterns: definition of the AC-29 pattern associated with antibodies to DNA topoisomerase I
- Reference standards for the detection of anti-mitochondrial and anti-rods/rings autoantibodies
- International Consensus on Antinuclear Antibody Patterns: defining negative results and reporting unidentified patterns