1450 – SELco^® TSH rapid

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. Furthermore, the assay provides accurate and reliable TSH measurements, enabling clinicians to detect both hypo- and hyperthyroidism at an early stage. It supports evaluation of the functional integrity of the hypothalamic-pituitary-thyroid axis and aids in monitoring therapy in thyroid disorder patients. Additionally, the assay can help identify autoimmune thyroiditis through the detection of relevant autoantibodies, contributing to differential diagnosis and long-term patient management. This information facilitates timely clinical decisions, guiding treatment selection and follow-up strategies. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

The biosynthesis of thyroglobulin (Tg) and the production of the thyroid hormones thyroxine (T4) and triiodothyronine (T3) are regulated by thyroid-stimulating hormone (TSH), also known as thyrotropin. 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.

Autoimmune thyroiditis involves autoantibodies that target thyroid antigens such as thyroid peroxidase, thyroglobulin, and the TSH receptor. These autoantibodies can impair thyroid hormone production and contribute to progressive gland dysfunction. Their detection provides strong evidence for chronic autoimmune thyroid disease and therefore serves as a valuable marker in the differential diagnosis of hypothyroidism, including subclinical or latent forms. Identifying these autoimmune mechanisms enables clinicians to establish appropriate long-term management and monitoring strategies.