In Vitro Diagnostics (IVD)

ELISA Immunoassay Chemiluminescence Immunoassay Molecular Diagnostics Point of Care Testing Cell Diagnostics

GB CL TSH Product

Human thyroid-stimulating hormone (TSH), also known as thyrotropin, is a glycoprotein synthesized by basophilic cells (thyrotropes) in the anterior pituitary. It is clinically utilized for diagnosing thyroid disorders and helps distinguish between primary (congenital), secondary (pituitary), or tertiary hypothyroidism.

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PRODUCT DESCRIPTION

GB CL TSH Product is intended for in vitro diagnostic (IVD) use. It utilizes the principle of chemiluminescent microparticle immunoassay (CMIA) and a quantitative sandwich assay to measure the concentration of thyroid-stimulating hormone (TSH) in human serum and plasma.The assay is performed using the "GBC Chemiluminescence Analyzer (Non-Sterile)."

PERFORMANCE

Limit of Quantitation (LoQ): 0.015 μIU/mL
Precision	Variability	Coefficient of variation, CV (%)
Repeatability	within run	<10%
Reproducibility	between-run/between-day	<10%
	between-sites/between-operators	<10%
	between-lots	<10%

SPECIFICATION

Principle	Sandwich-type chemiluminescent immunoassay
Assay format	Quantification
Rreaction time	20 minutes
Sample type	Serum/Plasma
Sample volume	80 μL
Detection unit	Relative light unit (RLU)
Storage	2-8°C. Avoid exposure to direct sunlight. Do not freeze.
Certification	RUO

ORDERING INFORMATION

Catalogue No.	Product
4ATSH02	GB CL TSH
4ATSH1B	GB CL TSH-Control
4ATSH2B	GB CL TSH-Calibrator