Intended Use
HCV iClia is a Chemiluminescence micro particle immunoassay designed for in vitro qualitative Detection of Antibodies to Hepatitis C virus (CORE, NS3, NS4 and NS5 antigens) in Human Serum/ 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
- 3rd Generation Assay
- Based on Indirect chemiluminescent immunoassay
- Unique combination of HCV antigens – Core, NS3, NS4 & NS5
- Acridinium Ester (AE) based kit for more accurate results
- Test results at 35 minutes
- Sensitivity: 100 %
- Specificity: 100%
- 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
Principle
HCV iClia is chemiluminescence micro particle immunoassay based on the “Indirect immunoassay” principle. The magnetic microparticles are coated with HCV antigens (CORE, NS3, NS4 and NS5). The samples are added in assay cup followed by addition of AE conjugate (anti-human IgG linked to acridinium ester). Antibodies to HCV, if present, bind to the immobilized HCV antigens on the microparticles during incubation. Unbound conjugate is then washed off with wash buffer. The amount of bound AE conjugate is proportional to the concentration of HCV antibodies present in the sample. Finally pretrigger 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 HCV antibodies present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the cut-off value.