3505 – Medizym^® T.R.A. human

Highlights

• 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.

The symptoms of Graves’ disease are very diverse: The consequences of an overactive thyroid (hyperthyroidism) range from insomnia, irritability, nervousness and tremors, sinus tachycardia, extrasystoles, atrial fibrillation, weight loss despite cravings, heat intolerance, sweating, osteoporosis and menstrual disorders. Excessive enlargement of the thyroid gland often causes difficulties in swallowing and a pronounced feeling of pressure in the throat. Outside the thyroid gland, Graves’ disease often manifests as an endocrine orbitopathy, which is characterized by protrusion of the eyeballs (exophthalmos).

The diagnosis of Graves’ disease is made on the basis of the clinical symptoms and confirmed by laboratory diagnostics by determining antibodies against the thyrotropin receptor (thyroid-stimulating hormone, TSH). TSH receptor antibodies (TRAb) are evidence of Graves’ disease. They stimulate the absorption of iodine and the production of thyroid hormones, which manifests itself in hyperthyroidism and thyroid growth (goiter). In the absence of TSH receptor antibodies, the determination of antibodies against thyroid peroxidase (TPO) and thyroglobulin (Tg) can support the diagnosis. For the further assessment of the thyroid function, the activity of the thyroid hormones TSH, T3 and T4 is determined.