In Vitro Diagnostics (IVD)

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

GB CL PSA Product

This product is used for the quantitative determination of total prostate-specific antigen (tPSA) levels in human serum or plasma. Prostate-specific antigen (PSA) is a glycoprotein with a molecular weight of approximately 30,000-34,000 Da, structurally similar to glandular kallikrein. PSA exhibits serine protease activity.

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PRODUCT DESCRIPTION

GB CL PSA 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 total prostate-specific antigen (tPSA) in human serum and plasma.The assay is performed using the "GBC Chemiluminescence Analyzer (Non-Sterile)."

PERFORMANCE

Limit of Quantitation (LoQ): 0.029 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	50 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
4APSA02	GB CL PSA
4APSA1B	GB CL PSA-Control
4APSA2B	GB CL PSA-Calibrator