Intended Use
Syphilis iClia is a Chemiluminescence microparticle immunoassay designed for in vitro. Qualitative detection of antibodies to Treponema pallidum (TP) in human serum or plasma and is used as a screening test for testing of collected blood prior to transfusion. This kit is only operational with J. Mitra CLIA Analyzer.
Salient Features
- First make in India product
- Based on Direct Sandwich chemiluminescent microparticle immunoassay
- Acridinium Ester (AE) based kit for more accurate results
- Test result at 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: 50 Test pack
- Prompt service back-up
Principle
Syphilis iClia is Chemiluminescence microparticle immunoassay based on the “Direct Sandwich” principle. The magnetic microparticles are coated with Syphilis antigen with high reactivity for Syphilis. The samples are added in assay cup followed by addition of AE conjugate (Syphilis antigens linked to acridinium ester). A sandwich complex is formed wherein Syphilis antibody (from serum sample) is “trapped” or “sandwiched” between the microparticles coated antigens and antigen labelled with AE conjugate. Unbound conjugate is then washed off with wash buffer. The amount of bound AE conjugate is proportional to the concentration of Syphilis 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 Syphilis antibodies present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the cut-off value.