Intended Use
Celiac iCLIA is a chemiluminescent microparticle immunoassay designed for in vitro qualitative detection of anti tTG IgA antibodies in Human Serum or Plasma. The assay is intended to be used as an aid in the recognition and diagnosis of Celiac disease. This kit is only operational in connection with J. Mitra CLIA Analyzer.
Salient Features
- Based on Indirect chemiluminescent microparticle immunoassay
- Acridinium Ester (AE) based kit for more accurate results
- Test result at 30 minutes
- Sensitivity: 100 %
- Specificity: 100%
- 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
Celiac iClia is chemiluminescent immunoassay based on the “Indirect” principle. The magnetic microparticles are coated with immunodominant epitopes of Recombinant Activated tissue transglutaminase (tTG). The samples /Controls/Calibrator are added in the assay cup containing coated microparticles. Anti-transglutaminase antibodies, if present in the specimen, will bind to the specific tTG antigen absorbed onto the surface of the microparticles. Unbound antibodies are then washed off with wash buffer followed by addition of AE conjugate (Anti-human IgA Antibody linked to acridinium ester) to assay cup. This conjugate will bind to tTG antigen-antibody complex present. The amount of bound AE conjugate is proportional to the concentration of Celiac IgA Antibodies present in the sample. Finally, pre-trigger and trigger solutions containing hydrogen peroxide and sodium hydroxide solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative Light units (RLUs). There is a direct relationship between the number of Celiac Antibodies (tTG IgA) present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the Calibrator.
