Intended Use
CEA iClia Kit is intended for the in vitro quantitative measurement of carcinoembryonic antigen (CEA) in human serum/plasma as an aid in clinical observation, prognostic and recurrence monitoring of malignant tumor. This kit is only operational with J. Mitra CLIA Analyzer.
Salient Features
- Based on Sandwich chemiluminescent microparticle immunoassay
- Acridinium Ester (AE) based kit for more accurate results
- Test result at 30 minutes
- Analytical sensitivity : 0.002 ng/ml
- Linearity : 0.002 ng/ml to 100 ng/ml
- Long shelf life: 12 months at 2-8oC
- Onboard stability of reagents: 30 days at 2-8oC
- Convenient pack size: 50 Test Pack
- Prompt service back-up
Principle
CEA iCLIA kit is a chemiluminescent based on “Sandwich principle”. The magnetic microparticles are coated with anti-CEA IgG antibodies. The samples are added in the assay cup containing assay buffer and anti-CEA IgG antibodies coated microspheres followed by addition of AE conjugate (anti-CEA IgG labeled acridinium ester conjugate) to assay cup. A sandwich complex is formed wherein CEA (from serum/plasma sample) is “trapped” or “sandwiched” between the microspheres coated antibody and antibody labelled with AE conjugate. Unbound conjugate is then washed off with the wash buffer. The amount of bound AE conjugate is proportional to the concentration of CEA present in the sample. Finally pre-trigger and trigger solution containing hydrogen peroxide and sodium hydroxide solution is added to reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). There is a direct relationship between the amount of CEA present in the sample and RLUs detected by the optical system. Results are calculated automatically based on the established calibration curve.