Uncut sheet for Thyroid Stimulating Hormone TSH Test

The Thyroid Stimulating Hormone (TSH) Rapid Test  (Uncut Sheet  for manufacturing use) is a fluorescence immunochromatographic assay intended for the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum, plasma, or whole blood specimens.

This test is intended for in vitro diagnostic professional use and serves as an aid in the evaluation of thyroid function, including the screening and diagnosis of thyroid disorders, and the monitoring of patients on thyroid replacement therapy

TSH is a glycoprotein hormone synthesized and secreted by the anterior pituitary gland. It regulates the production and secretion of thyroid hormones (T3 and T4) through a negative feedback mechanism. TSH measurement is established as the first-line test for initial evaluation of the hypothalamic-pituitary-thyroid axis function . The normal reference range for TSH in adults is approximately 0.3–4.2 µIU/mL, with age-specific variations

The device provides quantitative screening results. The test results are intended for clinical reference only. Definitive diagnosis should be based on a comprehensive assessment of clinical presentation, laboratory findings, and other diagnostic information. Results should be interpreted in conjunction with other thyroid function markers (e.g., free T4, free T3) when necessary. Positive/abnormal results (elevated or suppressed TSH) do not by themselves constitute a diagnosis of a specific thyroid disorder and require further clinical evaluation

This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.