Description:

The Diagnostic Automation Inc. TPO IgG ELISA test system is intended for the qualitative and semi quantitative detection of IgG-class antibody to thyroid peroxidase (TPO) in human serum. The test system is intended to be used as an aid in the diagnosis of thyroid diseases. This test is for in vitro diagnostic use only.

Thyroid antibodies are a characteristic finding in patients with Hashimotoâ??s and Gravesâ?? disease. The presence of thyroid antibodies in the sera of 80% of patients with these two diseases led to the recommendation that some type of thyroid antibody testing be a feature of the work-up of any patient with a goiter. Although thyroid antibodies are predominantly associated with Hashimotoâ??s or Gravesâ?? diseases, they may be found in the sera of patients with other diseases such as myxedma, granulomatous thyroiditis, nontoxic nodular goiter, and thyroid carcinoma. Thyroid antibodies are also found in most cases of lymphocytic thyroiditis in children, and rarely in patients with pernicious anemia and Sjögrenâ??s Syndrome.

The Diagnostic Automation Inc. (TPO) ELISA test system is designed to detect IgG class antibodies to TPO in human sera. Wells of plastic microwell strips are sensitized by passive absorption with TPO antigen. The test procedure involves three incubation steps: (1) Test sera (properly diluted) are incubated in antigen coated microwells. Any antigen specific antibody in the sample will bind to the immobilized antigen. The plate is washed to remove unbound antibody and other serum components. (2) Peroxidase conjugated goat anti-human IgG (γ chain specific) is added to the wells and the plate is incubated. The conjugate will react with antibody immobilized on the solid phase in step 1. The wells are washed to remove unreacted conjugate. (3) The microwells containing immobilized peroxidase Conjugate are incubated with peroxidase Substrate solution. Hydrolysis of the substrate by peroxidase produces a color change. After a period of time the reaction is stopped and the color intensity of the solution is measured photometrically. The color intensity of the solution depends upon the antibody concentration in the original test sample.