Thermo Fisher Scientific Inc, Waltham, Mass, has received FDA premarket notification (510(k)) clearance for two enzyme-labeled antiisotope immunoassays (EliAs) for detecting antithyroglobulin (anti-TG) and antithyroid peroxidase (anti-TPO) autoantibodies in serum or plasma. Designated as moderately complex under the terms of the Clinical Laboratory Improvement Amendments of 1988, the EliA laboratory tests are performed on the fully automated Phadia 250, 2500, and 5000 laboratory systems.
Thyroid autoimmunity comprises a number of distinct but pathogenically related autoimmune disorders of the thyroid gland, such as Graves’ disease or Hashimoto’s thyroiditis. Among other traits, these diseases are characterized by the presence of autoantibodies such as thyrotropin receptor, TG, or TPO. More than 98% of Hashimoto’s thyroiditis patients have autoantibodies directed to TG, TPO, or both.
The EliA anti-TG and anti-TPO tests quantitatively measure a patient’s autoantibodies to thyroglobulin or thyroid peroxidase, providing information that can help clinicians in the diagnosis of autoimmune thyroid disease. Formerly offered on the ImmunoCap technology platform, the EliA tests are designed to provide higher sensitivity with similar or higher specificity, minimizing false negative or positive results and maximizing detection of serious disease.
For more information, visit Thermo Fisher Scientific.
