Description
Product Specifications
COA
IFU
Instrument
Description
Carbohydrate Antigen 19-9 (CA19-9) also known as sialyl-LewisA, is a tetrasaccharide which is usually attached to O-glycans on the surface of cells. It synthesized and secreted by normal human pancreatic cells, biliary ductular cells, gastric epithelial cells, colon epithelial cells, endometrial cells and salivary gland epithelial cells. Elevated CA19-9 levels usually associated with colorectal carcinoma (30%), pancreatic tumors (80%), hepatobiliary tumors (67%), stomach cancers (40 to 50%), hepatocellular carcinoma (30 to 50%), breast cancer (15%). In addition, it has been reported that elevated CA 19-9 levels can be found in other non-malignant conditions such as pulmonary and thyroidal diseases, diabetes mellitus, and gynecologic disease. CA 19-9 is an important indicator for diagnosis and response to treatment and the surveillance of pancreatic or hepatobiliary cancers.
Product Specifications
Intended Use
Carbohydrate Antigen 19-9 Assay Kit is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative
determination of Carbohydrate Antigen 19-9 (CA19-9) in human serum and plasma. The assay kit is intended for in vitro
diagnostic use.
Principle
The Carbohydrate Antigen 19-9 assay is a quantitative sandwich immunoassay to determine the presence of CA19-9 in human serum
and plasma using CMIA technology with flexible assay protocols.
- Sample, paramagnetic anti-CA19-9 coated microparticles and a conjugate containing acridinium-labeled anti-CA19-9 are mixed, CA19-9 present in the sample binds to anti-CA19-9 coated microparticles and acridinium-labeled anti-CA19-9, forming an antigen antibody complex
- After further incubation and washing, Pre-Trigger and Trigger Solutions are added to the reaction mixture.
- The resulting chemiluminescent reaction is measured as relative light units (RLUs). There is a relationship between the amount of CA19-9 in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the previously established calibration curve.
Storage
The kit should be stored upright, not upside down or horizontally. Store at 2–8°C with a validity period of 12 months.
COA
IFU
Instrument