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HEPALISA

 

INTENDED USE

HEPALISA 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

  • Detects all the known 11-subtypes of HBV
  • Antigen Sensitivity-0.1ng/ml.
  • Two step Immunoassay.
  • Short protocol: Based on single washing step.
  • Assay Procedure: 90 mins.
  • Shelf life-15 months at 2-8°C.
  • Convenient pack size :96 tests
  • Break-away wells for minimal wastage
  • Easy interpretation of result
  • Sensitivity & Specificity 100% by WHO.
HEPALISA is a solid phase enzyme linked immunosorbent assay based on the Direct Sandwich Elisa 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 HBsAg in 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
PRODUCT NAME PACK SIZE CATALOG NO.
HEPALISA 96 Tests IR020096

EVALUATIONS
  • WHO EVALUATION:The kit has been evaluated by WHO Collaborating Centers by using a panel of 276 sera consisting of samples from Latin America, Asia, European, African origin , Various sero-conversion panels from BBI , world wide performance panel and one HBsAg low titer performance panel. The Evaluation indicates the following sensitivity and specificity: Sensitivity- 100 % & Specificity-100 %
  • BANGALORE MEDICAL COLLEGE :The overall Sensitivity & Specificity was found to be 100%
  • The kit has also been evaluated from National Institute of Virology-Pune & National Institute of Cholera & Enteric diseases and the overall Sensitivity & Specificity was found to be 100 % .
  • Approved by Drug Controller General of India( DCGI) for the usage in Blood Banks.

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