Intended Use
Lepto IgM iClia is a chemiluminescent microparticle immunoassay designed for in vitro qualitative detection of Leptospira IgM antibodies in human serum or plasma and is used as a screening test for testing of collected blood samples suspected for Leptospirosis infection. 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 within 45 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
Lepto IgM iClia is chemiluminescent immunoassay based on the “Indirect” principle. The magnetic microparticles are coated with recombinant protein representing immunodominant epitopes of Leptospira. The samples are added in the assay cup containing coated microparticles. IgM antibodies to Leptospira if present in the specimen, will bind to the specific Leptospira 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 IgM Antibody linked to acridinium ester) to assay cup. This conjugate will bind to Leptospira antigen-antibody complex present. The amount of bound AE conjugate is proportional to the concentration of Leptospira 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 Leptospira IgM Antibodies present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the Calibrator.
