3002 – Medizym^® anti-TPO

Highlights

• Use of recombinant human thyroid peroxidase (TPO)
• Ready-to-use (exception: wash buffer) and barcoded reagents
• Quality assured handling in routine laboratories
• Incubation at room temperature
• Quantitative determination of IgG antibodies against human TPO
• Calibrated with the international standard preparation NIBSC code 66/387
• Results expressed in IU/mL
• Excellent diagnostic sensitivity and specificity
• High precision within the measurement range
• CE marked
• Automatable

Intended Use

The Medizym^® anti-TPO is a quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of IgG antibodies against thyroid peroxidase (TPO) in human serum. The Medizym^® anti-TPO is intended as an aid in the diagnosis of autoimmune diseases of thyroid gland in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

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 often than men. Researchers have not yet clarified the exact causes of disease onset, but they consider genetic factors, stress, environmental influences, viral infections, and excessive iodine intake as potential contributors.

The symptoms of Hashimoto’s thyroiditis are diverse. At the onset of the disease, patients may experience hyperthyroidism, which can cause nervousness, sweating, overactivity, increased appetite, weight loss, tachycardia, cardiac arrhythmias, and arterial hypertension for a certain period. 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.

Clinicians usually diagnose Hashimoto’s thyroiditis based on clinical symptoms and confirm it by measuring antibodies against thyroid peroxidase (TPO) and thyroglobulin (Tg). To further assess thyroid function, they measure thyroid hormones TSH (thyroid-stimulating hormone), T3 (triiodothyronine), and T4 (thyroxine). Physicians may also perform a sonography, analyze thyroid tissue from a biopsy, or create a scintigram using radioactively labeled iodine.