Intended Use
Dengue IgG iClia is a chemiluminescent microparticle immunoassay designed for in vitro qualitative detection of Dengue IgG 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 GAC 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 IgG iClia is chemiluminescent immunoassay based on the “GAC CAPTURE” principle. The magnetic microparticles are coated with Anti-Human IgG antibodies.
The samples are added in the assay cup containing coated microparticles. Antibodies to Dengue IgG if present in the specimen, will bind to the Anti-human IgG 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 IgG antibodies which is complexed with anti- human IgG antibodies. The amount of bound AE conjugate is proportional to the concentration of dengue IgG 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 IgG Antibodies present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the Calibrator.
