HBsAg iClia

Infectious Range

HBsAg iClia

Test Kit Type HBsAg CLIA Test Kit
Pack Size 50 Test pack, 100 Test pack
Sensitivity 0.050ng/ml
Specificity 100%
Shelf Life 12 months at 2-8°C

Product description

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

4^th 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
First make in India product

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. Performance Characteristics Diagnostic Sensitivity: 100 % Diagnostic Specificity: 100% Analytical Specificity: 100% Analytical Sensitivity:

The sensitivity of the kit has been determined using WHO standard (Second international standard for HBsAg subtype adw2 geno type A) and it is equal to 0.130 IU/ml.
HBsAg iClia has a sensitivity of 0.050ng/ml for all the 11 subtypes (ad & ay subtype) including mutant strains.

Precision:

The test results are repeatable with HBsAg positive samples (Weak and strong) and kit controls in within run precision testing with CV <10%.
The test results are reproducible with HBsAg positive samples (Weak and strong) and kit controls in between run precision testing with CV <15%.
The test results are reproducible with HBsAg positive samples (Weak and strong) and kit controls in between instrument precision testing with CV <15%.