Intended Use
Chikungunya IgM iClia is a chemiluminescent microparticle immunoassay designed for in vitro qualitative measurement of Chikungunya IgM antibodies in human serum or plasma and is used as a screening test for testing of collected blood samples suspected for Chikungunya. This kit is only operational in conjunction with J. Mitra CLIA Analyzer.
Salient Features
- Based on MAC Capture chemiluminescent microparticle immunoassay
- Acridinium Ester (AE) based kit for more accurate results
- Test result within 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 Tests
- Prompt service back-up
Principle
Chikungunya IgM iClia is chemiluminescent immunoassay based on the “MAC CAPTURE” principle. The magnetic microparticles are coated with Anti-Human IgM antibodies. The samples are added in the assay cup containing coated microparticles. Antibodies to Chikungunya IgM if present in the specimen, will bind to the Anti human IgM antibodies absorbed onto the surface of the microparticles. Unbound antibodies are then washed off with wash buffer followed by addition of chikungunya antigen and anti-chikungunya antibodies linked to Acridinium Ester to assay cup. This linked AE will bind to Chikungunya antigen. The amount of bound AE conjugate is proportion to the concentration of chikungunya IgM antibodies present in the sample. Finally pretrigger and trigger solution containing hydrogen peroxide and sodium hydroxide solution is added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative Light units (RLUs). There is a direct relationship between the amount of Chikungunya IgM Antibodies present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the Calibrator.
