In Vitro Diagnostics (IVD)

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

GB CL CEA Product

Carcinoembryonic antigen (CEA) is a glycoprotein involved in cell adhesion. After birth, CEA synthesis is suppressed, resulting in extremely low levels in the blood of healthy adults. However, CEA is abundantly produced in human colon adenocarcinoma and has been clinically correlated with other cancers.

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PRODUCT DESCRIPTION

GB CL CEA 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 carcinoembryonic antigen (CEA) in human serum and plasma.The assay is performed using the "GBC Chemiluminescence Analyzer (Non-Sterile)."

PERFORMANCE

Limit of Quantitation (LoQ): 0.32 ng/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	10 minutes
Sample type	Serum/Plasma
Sample volume	30 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
4ACEA02	GB CL CEA
4ACEA1B	GB CL CEA-Control
4ACEA2B	GB CL CEA-Calibrator