2042 – SELco® TRAb human 1 step
Highlights
• Use of recombinant human TSH receptor
• Ready-to-use and barcoded reagents
• Quality assured handling in routine laboratories
• Incubation at room temperature
• Quantitative determination of antibodies against the human TSH receptor
• 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
Der SELco® TRAb human 1 step ist ein quantitativer Immunoassay zur Bestimmung von Antikörpern gegen den TSH Rezeptor in humanem Serum. Der SELco® TRAb human 1 step dient zur Unterstützung bei der Diagnose von Schilddrüsenerkrankungen in Verbindung mit anderen klinischen und laboratoriumsmedizinischen Untersuchungen. Der Immunoassay ist für den manuellen professionellen in-vitro diagnostischen Gebrauch bestimmt.
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.
Product Specifications
Title | SELco® TRAb human 1 step |
Product code | 2042 |
Indication | Graves´ Disease |
Description | Radioimmunoassay for the quantitative determination of antibodies against TSH receptor (TRAb) in human serum |
Format | Coated tube technology |
Total incubation time | 120 min. |
Sample volume | 100 µL |
No. of determinations | 100 (93 x 1) + 5 x Calibrators + 2 x Controls |
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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.