Laboratory Testing for Autoimmune Thyroid Diseases
Bringing Clarity to the Underlying Cause

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Autoimmune thyroid diseases (AITD) affect around 5% of the world population and are up to 6 times more common in women than in men.1, 2 Inflammation of the thyroid gland (thyroiditis) can lead to its dysfunction, affecting the whole body and leading to a loss in the quality of life.2 Graves’ disease and Hashimoto’s thyroiditis are the most frequent forms of AITD and the main etiologies of hyper- and hypothyroidism1, 3 . However, vague signs and overlapping symptoms between various thyroid conditions can make it challenging to determine the underlying cause. Enabling clinicians to differentiate these diseases from non-autoimmune thyroid dysfunction and to make well-informed treatment decisions leads to better patient care.1, 2

The measurement of autoantibodies directed against the major thyroid proteins is a pivotal part of the diagnostic algorithm for both Hashimoto’s thyroiditis and Graves’ disease.2, 3

The most relevant thyroid autoantibodies are:

  • Anti-thyroid stimulating hormone receptor antibodies (anti-TSH-R): A specific serological marker for the differential identification of Graves’ disease from other causes of hyperthyroidism and thyrotoxicosis.4 
  • Anti-thyroid peroxidase antibodies (anti-TPO): A serological marker for the diagnosis of Hashimoto’s thyroiditis but also detectable in up to 80 percent of Graves’ disease patients.5 
  • Anti-thyroglobulin antibodies (anti-TG): Often detected together with anti-TPO, but due to their different prevalences, AITD patients can be positive for anti-TPO but negative for anti-TG, and vice versa.5, 6

Polyautoimmunity in AITD patients:

  • About 1 out of 7 AITD patients suffers from one or several concomitant (intercurrent) autoimmune diseases.1
  • These concomitant (intercurrent) autoimmune diseases include rheumatoid arthritis, celiac disease, pernicious anemia, inflammatory bowel diseases as well as connective tissue diseases such as systemic lupus erythematosus and systemic sclerosis.1, 7
  • AITD patients with polyautoimmunity may have a modified disease course, an atypical clinical presentation and may develop non-specific symptoms.1, 3, 8
  • Based on the overall condition and symptoms of an AITD patient, screening for polyautoimmunity is recommended.7, 8

Find out more about “Criteria and Tests for Autoimmune Disease Diagnosis” 


 

Why choose Thermo Fisher Scientific as your partner for autoimmune thyroid disease diagnosis?

 

Helping get it right, the first time.

In diseases such as AITD, where patients can often present with vague symptoms, specificity is key. With EliA anti-TSH-R, EliA anti-TPO and EliA anti-TG tests, we offer a fully automated and specific autoantibody test panel to support the diagnosis of AITD.

In an analysis of 200 samples from patients with AITD and 200 disease control samples, EliA anti-TPO had a sensitivity of 81.5% and a specificity of 96% while EliA anti-TG had a sensitivity of 52.5% and a specificity of 94%. Of the AITD samples, 8 were identified as single positive for anti-TG.9

In an analysis of 60 samples from Graves’ disease patients and 255 disease controls, EliA anti-TSH-R had a sensitivity of 96.7% and a specificity of 98.8%.9

Besides tests for the detection of thyroid antibodies, the EliA portfolio comprises tests to support the diagnoses of rheumatoid arthritis, celiac disease, pernicious anemia, inflammatory bowel diseases and connective tissue diseases like systemic lupus erythematosus and systemic sclerosis.

Find out more about the full EliA test portfolio in the EliA product catalog.

Manufactured to the highest standards to ensure clinical relevance. The antigens for EliA thyroid tests are produced with high purity and reproducibility to ensure a high lot-to-lot consistency. While TG is purified from human thyroid glands, recombinant human TSH-R and recombinant human TPO are routinely produced in eukaryotic expression systems providing independence from native antigen sources.

EliA anti-TPO was the first test to use recombinantly produced TPO as antigen thereby eliminating the need to purify TPO from thyroid glands that can be contaminated with the excessively abundant TG.10, 13

Optimized for lean working. EliA thyroid tests are standardized to the EliA FEIA technology and enable you to perform all three relevant thyroid antibody tests from one sample in one run and on the same fully automated Phadia™ Laboratory Systems. This means that you and your clinical customers can apply the same thyroid positive control for all EliA thyroid tests and share common system reagents, saving time and reducing costs. Due to the IgG isotype specific calibration curve used on the Phadia Laboratory Systems, all EliA tests measuring a specific IgG antibody, e.g. EliA anti-TPO, EliA anti-TG and EliA CCP, can be performed using this IgG isotype specific calibration curve. This shared IgG isotype specific calibration curve offers an additional degree of flexibility when additional testing of a patient sample is needed.

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References
  1. Rema J, et al. Autoimmune thyroid diseases in The General Practice Guide to Autoimmune Diseases. Pabst Science Publishers, Lengerich 2012
  2.  Botello A, et al. Prevalence of latent and overt polyautoimmunity in autoimmune thyroid disease: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2020;93:375-389.
  3. Franco JS, et al. THYROID DISEASE AND AUTOIMMUNE DISEASES. In AUTOIMMUNITY From Bench to Bedside. editors: Anaya JM, Sheonfeld Y, Rojas-Villarraga A, Levy RA, Cervera R. Bogota, Columbia: El Rosario University Press; 2013:537-561.
  4.  Menconi F, et al. Diagnosis and classification of Graves' disease. Autoimmun Rev. 2014;13(4-5):398-402.
  5. Saravanan P and Dayan CM. Thyroid autoantibodies. Endocrinol Metab Clin North Am. 2001;30(2):315-37, viii.
  6. Hollowell JG, 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(2):489-99.
  7. Fallahi P, et al. The association of other autoimmune diseases in patients with autoimmune thyroiditis: Review of the literature and report of a large series of patients. Autoimmun Rev. 2016;15(12):1125-
  8. Bliddal S, et al. Recent advances in understanding autoimmune thyroid disease: the tallest tree in the forest of polyautoimmunity. F1000Res. 2017;6:1776.
  9. Thermo Fisher Scientific. Internal study. Data on file.
  10. Berthold H, et al. Human thyroid peroxidase: autoantibody recognition depends on the natural conformation. J Clin Lab Anal. 1993;7(6):401-4.
  11. Haubruck H, et al. Expression of recombinant human thyroid peroxidase by the baculovirus system and its use in ELISA screening for diagnosis of autoimmune thyroid disease. Autoimmunity. 1993;15(4):275-84.
  12. Schmitt J and Papisch W. Recombinant autoantigens. Autoimmun Rev. 2002;1(1-2):79-88.
  13.  McLachlan SM, et al. Thyroid peroxidase and the induction of autoimmune thyroid disease. Clin Exp Immunol. 1990;79(2):182-8.