1450 – SELco^® TSH rapid

Highlights

• Quantitative determination of Thyrotropin (TSH) in human serum
• Immunoradiometric assay (IRMA) based on coated-tube technology
• Analytical sensitivity: LoD 0.036 mIU/L; LoQ 0.070 mIU/L
• No high-dose hook effect up to 8000 µIU/mL
• Calibrated against WHO 3rd IRP 81/565
• Ready-to-use coated tubes, tracers, calibrators, and control sera
• CE marked

Intended Purpose

The SELco® TSH rapid is a quantitative radioimmunoassay for the determination of thyrotropin (TSH) in human serum.The SELco® TSH rapid is intended as an aid in the diagnosis of thyroid diseases in conjunction with other clinical and laboratory findings. The assay provides accurate and reliable TSH measurements to support the assessment of thyroid function and the diagnosis and monitoring of thyroid disorders. TSH measurement supports assessment of thyroid function. Determination of thyroid autoantibodies requires separate assays and should be considered only when clinically indicated. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Thyroid-stimulating hormone (TSH), also known as thyrotropin, regulates the synthesis of thyroglobulin (Tg) and stimulates the production of the thyroid hormones thyroxine (T4) and triiodothyronine (T3). Secreted by the anterior pituitary gland, TSH stimulates the thyroid to produce and release T4 and T3. These hormones play a vital role in metabolism, growth, and energy regulation. Feedback regulation controls their levels tightly: elevated T3 or T4 suppresses TSH secretion, while low hormone levels increase TSH production. Consequently, serum TSH is a sensitive and early indicator of primary hypothyroidism, often increasing before T4 levels fall outside the reference range.

TSH measurement supports assessment of thyroid function and is a sensitive indicator of primary thyroid dysfunction. Determination of thyroid autoantibodies requires separate assays and should be considered only when clinically indicated.