• Use of recombinant human TSH receptor
• Ready-to-use (exception: conjugate and wash buffer) and barcoded reagents
• Quality assured handling in routine laboratories
• Incubation at room temperature
• Quantitative determination of antibodies against the TSH receptor (TRAb)
• Calibrated with the international standard preparation NIBSC code 08/204
• Results expressed in IU/L
• Excellent diagnostic sensitivity and specificity
• High precision within the measurement range
• CE marked
• Automatable
Intended Use
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. The immunoassay is designed for manual professional in vitro diagnostic use.
Diagnostic Relevance
Graves’ disease is an autoimmune disease of the thyroid gland that leads to enlargement (goiter) and an excessive production of the thyroid hormones triiodothyronine (T3) and thyroxine (T4). In countries with a good iodine supply, Graves’ disease is the most common cause of hyperthyroidism. Women are more affected than men. The exact causes that lead to the onset of the disease have not yet been clarified, but in addition to genetic factors, stress and environmental influences as well as viral infections are discussed as potential causes.