2085 – SELco® anti-Tg human

Highlights

• Use of recombinant human thyroglobulin (Tg)
• Based on coated tube technology using human polyclonal anti-Tg antibodies
• High diagnostic sensitivity and specificity for autoimmune thyroid diseases
• Suitable as an aid in the diagnosis of autoimmune thyroiditis, Graves’ disease and hypothyroidism
• High precision within the measurement range
• CE marked
• Intended for professional manual in vitro diagnostic use


Intended Use

The SELco® anti-Tg human is a quantitative immunoassay for the determination of antibodies against thyroglobulin (Tg) in human serum. The SELco® anti-Tg human is intended as an aid in the diagnosis of thyroid diseases in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.


Diagnostic Relevance

Overview

Hashimoto’s thyroiditis is a polyendocrine autoimmune disease characterized by chronic inflammation of the thyroid gland. Antibodies, in particular against thyroid peroxidase (TPO) and thyroglobulin (Tg), lead to the destruction of thyroid tissue and thus to hypothyroidism in the long term, although phases of hyperthyroidism can also appear at the beginning of the disease.

Hashimoto’s thyroiditis is one of the most common autoimmune diseases and the most common cause of hypothyroidism. Women develop the disease more frequently than men. The exact causes of disease onset remain unclear; however, researchers discuss genetic factors, stress, environmental influences, viral infections, and excessive iodine intake as potential contributors.

The symptoms of Hashimoto’s thyroiditis are diverse. Due to a possible hyperthyroidism at the beginning of the disease, nervousness, sweating, overactivity, increased appetite, weight loss, tachycardia and cardiac arrhythmias as well as arterial hypertension can be observed for a certain time. In the long term, however, the symptoms of an underactive thyroid gland predominate with fatigue, exhaustion, difficulty concentrating, depression, intolerance to cold, weight gain despite loss of appetite, constipation, menstrual disorders and bradycardia.

Diagnosis

Clinicians usually make the diagnosis based on clinical symptoms and confirm it through laboratory diagnostics by determining antibodies against thyroid peroxidase (TPO) and thyroglobulin (Tg). To further assess thyroid function, they measure the activity of the thyroid hormones TSH (thyroid-stimulating hormone), T3 (triiodothyronine), and T4 (thyroxine). In addition, physicians may perform sonography, analyze thyroid tissue obtained by biopsy using histology, or create a scintigram after administering radioactively labeled iodine preparations.

Product Specifications

Title SELco® anti-Tg human
Product code 2085
Indication Thyroid diseases
Description Radioimmunoassay for the quantitative determination of antibodies against Thyroglobulin (Tg) in human serum
Format Coated tube technology
Total incubation time 120 min.
Sample volume 100 µL
No. of determinations 100 (92 x 1) + 6 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.