Intended Use
4th Generation HBsAg iClia is a Chemiluminescence microparticles immunoassay designed for in vitro qualitative detection of HBs (surface antigen) antigen 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
- 4th Generation HBsAg assay
- Based on Direct Sandwich Chemiluminescence Immunoassay
- Detects all the known 11 subtypes of HBV and also mutant strains
- Acridinium Ester (AE) based kit for more accurate results
- Test results at 20 minutes
- Sensitivity: 100 %
- Specificity: 100%
- Analytical Sensitivity: 0.050ng/ml
- Long Shelf life: 12 months at 2-8°C.
- Onboard stability of reagents: 30 days at 2-8°C.
- Convenient Pack Size: 50 Test pack, 100 Test pack.
- Prompt Service back-up
Principle
HBsAg iClia is chemiluminescence microparticle immunoassay based on the “Direct Sandwich” principle. The magnetic microparticles are coated with Anti-HBsAg antibodies with high reactivity for HBsAg. The samples are added in assay cup followed by addition of AE conjugate (anti-HBsAg antibodies linked to acridinium ester). A sandwich complex is formed wherein HBsAg (from serum sample) is “trapped” or “sandwiched” between the microparticles coated antibody and antibody 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 HBsAg 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 HBsAg present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the cut-off value.