This reagent is an in-vitro diagnostic quantitative assay, using chemiluminescent immunoassay (CLIA) sandwich format, for measuring human TSH in serum or plasma. It requires 80 µL sample volume and delivers results in 20 minutes. With a detection limit of 0.015 µIU/mL, it detects very low TSH concentrations. Stored at 2-8°C, avoid light exposure and freezing. Ideal for diagnosing primary, pituitary, or hypothalamic causes of thyroid dysfunction and monitoring recovery or therapy.