3505 – Medizym® T.R.A. human

The Medizym® T.R.A. human is a quantitative immunoassay for the determination of antibodies against Thyrotropin (TSH) receptor in human serum. The Medizym® T.R.A. human is intended as an aid in the diagnosis of Graves’ disease in conjunction with other clinical and laboratory findings.

Thyrotropin (thyroid stimulating hormone (TSH)) receptor autoantibodies (TRAb), a hallmark of Graves’ disease, provides an effective means for the disease’ diagnosis: These autoantibodies mimic effects of TSH on the thyroid cell leading to increased blood levels of thyroxine (T4) and triiodothyronine (T3). Detection and quantification of these antibodies provide a valuable means for the differential diagnosis of hyperthyroidism and control of Graves’ disease.

The competitive ELISA (Enzyme Linked Immunosorbent Assay) is an immunoassay for the determination of specific antibodies. The strips of the microtiter plate are coated with test-specific antigens. If antibodies are present in the patient´s sample, they bind to the antigens. A second biotinylated tracer antibody targets the remaining accessible binding sites of the coated antigen. Streptavidin conjugated with the enzyme peroxidase binds the immobilized biotinylated antibody. A colorless substrate is converted into the colored product by the peroxidase. The signal intensity of the reaction product is indirectly proportional to the antibody activity in the sample. After stopping the signal intensity of the reaction product is measured photometrically.

The immunoassay is designed for manual professional in vitro diagnostic use.