Intended Use
Dengue IgM iClia is a chemiluminescent microparticle immunoassay designed for in vitro qualitative detection of Dengue IgM antibodies in human serum or plasma and is used as a screening test for testing of collected blood samples suspected for Dengue. The kit detects all four subtypes; DEN1, DEN2, DEN3 & DEN4 of Dengue Virus. 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
- Detection of all 4 serotypes of Dengue (DEN 1 – DEN 4)
- Test result within 55 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: 100 Tests
- Prompt service back-up
Principle
Dengue IgM iClia is chemiluminescence 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 Dengue 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 AE conjugate (Dengue antigen (DEN1-4) linked to acridinium ester) to assay cup. This dengue antigen conjugate will bind to dengue specific IgM antibodies which is complexed with anti- human IgM antibodies. The amount of bound AE conjugate is proportional to the concentration of dengue IgM Antibodies present in the sample. Finally pre-trigger 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 dengue IgM Antibodies present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the Calibrator.
