1450 – SELco® TSH rapid

Medipan GmbH, in partnership with GA Generic Assays GmbH, offers advanced diagnostic solutions for thyroid diseases worldwide. Our innovative test kits and automated systems, spanning ELISA to lateral flow assays, empower healthcare professionals with accurate and efficient diagnostic tools. With a global presence in over 70 countries, we are committed to improving the detection and management of thyroid disorders for better patient outcomes.

Intended Purpose

The SELco® TSH rapid is a quantitative immunoassay 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 immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

The biosynthesis of Tg is regulated by thyroid-stimulating hormone (TSH), also known as thyrotropin, a pituitary hormone that stimulates the thyroid gland to produce thyroid hormones thyroxine (T4), and then triiodothyronine (T3). T4 and T3 regulate the secretion of TSH by a negative feedback mechanism; T3 or T4 elevation suppresses TSH in the serum, whereas their fall increase the level of TSH in serum, an early and specific indicator of primary hypothyroidism.

The presence of autoantibodies to thyroid antigens is an indication of autoimmune thyroiditis. These autoantibodies target the thyroid glands and its hormone products T3, T4 and TSH leading to hormonal dysfunction. Detection of such autoantibodies in an indication of chronic autoimmune thyroiditis, hence a marker for the differential diagnosis of hypothyroidism and the subclinical or latent type.

Product Specifications

Title SELco® TSH rapid
Product code 1450
Indication Thyroid diseases
Description Radioimmunoassay for the quantitative determination of Thyrotropin (TSH) in human serum
Format Coated tube technology
Total incubation time 30 minutes
Sample volume 100 µL
No. of determinations 100 (91 x 1) + 7 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.