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Sample Collection for Clinical Performance Evaluation of Elecsys Anti-TPO II

Grave's disease, Multinodular goiter, Rheumatoid arthritis, Subacute thyroiditis, Systemic lupus erythematosus, Thyroid cancer, Thyroid nodules, Type I diabetes
All genders
person-wave 22-79


Principal Investigator: Feyza Erenler, MD

The purpose of this study is to collect blood samples for the further development of the diagnostic test Elecsys® Anti TPO II (anti-thyroid peroxidase antibody). This updated test is to aid in the diagnosis of autoimmune thyroid diseases like Hashimoto thyroiditis or Graves’ disease. In blood of patients suffering from these diseases, antibodies like anti-TPO are generally elevated. In the This study, the patient's blood sample will be analyzed with the updated Elecsys® Anti-TPO II test. The anti TPO levels from blood of patients with Hashimoto thyroiditis or Graves’ disease will be compared with levels from blood of patients with non-autoimmune thyroid diseases (e.g. thyroid cancer) or autoimmune non-thyroid diseases (e.g. Type I diabetes mellitus). This comparison will help to understand how good the Anti-TPO test can aid in the diagnosis of autoimmune thyroid diseases.

Participation in this study will involve one visit and will last approximately 30 minutes. We expect approximately 660 people in the US will participate in the study in the US in accordance with applicable national laws and globally recognized principles. Participation in this study will involve one blood collection for research purposes.

Study details

Inclusion Criteria
  • Age >= 22 to 79 years of age
  • There are four patient population groups being recruited for this study:
    - Diagnosis within two years of Hashimoto's thyroiditis Diagnosis within one year of Graves' disease
    - Diagnosis of multinodular goiter, isolated thyroid nodules, active thyroid cancer, or subacute thyroiditis within two months
    - Diagnosis of type 1 diabetes, systemic lupus erythematosus, rheumatoid arthritis, Sjogren's Syndrome, scleroderma, primary biliary cholangitis/cirrhosis, or autoimmune pernicious anemia
Exclusion Criteria
  • Partial or total thyroidectomy
  • Corticosteroid therapy
Study Requirements

This study involves one visit where medical history will be reviewed to see if the patient meets the study criteria after which a single blood sample (10mL, about 1 tablespoon) will be taken from the patient's arm. The visit will last about 30 minutes.

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