Hepalisa Ultra

Intended Use

Hepalisa Ultra is designed for in-vitro qualitative detection of Hepatitis B Surface antigen (HBsAg) in human serum or plasma and is used as a screening test for testing of collected blood prior to transfusion.

Salient Features

• 4^th Generation HBsAg detection kit
• Based on Direct Sandwich principle
• Detects all the known 11 subtypes of HBV and also mutant strains
• Antigen sensitivity: 0.05 ng/ml
• Ready to use conjugate
• Easy Interpretation of results
• Shelf life 24 Months, Storage at 2-8°C
• Available in convenient Packsize of 96 Tests
• Specificity: Increased power of discrimination between positive & negative samples.

Principle

4^th Generation Hepalisa Ultra is a solid phase enzyme linked immunosorbent assay (Elisa) based on the “Direct sandwich” principle. The microwells are coated with Monoclonal antibodies with high reactivity for HBsAg. The samples are added in the wells followed by addition of enzyme conjugate (polyclonal antibodies linked to Horseradish Peroxidase (HRPO)). A sandwich complex is formed in the well wherein HBsAg (from serum sample) is ‘’trapped’’ or ‘’sandwiched’’ between the antibody and antibody HRPO conjugate. Unbound conjugate is then washed off with wash buffer. The amount of bound peroxidase is proportional to the concentration of HBsAg present in the sample.

Upon addition of the substrate buffer and chromogen, a blue colour develops. The intensity of developed blue colour is proportional to the concentration of the HBsAg in the sample. To limit the enzyme-substrate reaction, stop solution is added and a yellow colour develops which is finally read at 450 nm spectrophotometrically.

Ordering Information

Performance Characteristics

(i) Analytical Sensitivity : The sensitivity of the Hepalisa Ultra kit has been determined using WHO standard (Second international standard for HBsAg subype adw2 geno type A) and it is equal to 0.130 IU/ml.

4^th Generation Hepalisa Ultra has a sensitivity of 0.050ng/ml for all the 11 subtypes (ad & ay subtype) including mutant strains.

(ii) The performance of 4^th Generation Hepalisa Ultra has been evaluated in house with fresh as well as frozen samples. The testing has been done with clinical samples, samples from random blood donors, cross reacting samples; RA, CRP, ASO and patients with diseases related to HBV. The results of in-hoouse studies are as follows:

Sensitivity: 100%
Specificity: 99.92%