MicroELISA

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EIAgen HBsAg Kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of HBsAg in human serum or plasma (EDTA, sodium citrate or heparin). It is intended for screening of blood donors and for diagnosing of patients related to infection with hepatitis B virus.
For “in vitro” diagnostic use only.

Hepatitis B virus (HBV) is an enveloped, double-stranded DNA virus belonging to the Hepadnaviridae family and is recognized as the major cause of blood transmitted hepatitis together with hepatitis C virus (HCV). Infection with HBV induces a spectrum of clinical manifestations ranging from mild, inapparent disease to fulminant hepatitis, severe chronic liver diseases, which in some cases can lead to cirrhosis and carcinoma of the liver.
Classification of a hepatitis B infection requires the identification of several serological markers expressed during three phases (incubation, acute and convalescent) of the infection. Now several diagnostic test are used for screening, clinical diagnosis and management of the disease. Hepatitis B surface antigen or HBsAg, previously described as Australia antigen, is the most important protein of the envelope of Hepatitis B Virus. The surface antigen contains the determinant “a”, common to all known viral subtypes and immunologically distinguished in two distinct subgroups (ay and ad). HBV has 10 major serotypes and four HBsAg subtypes have been recognized (adw, ady, ayw, and ayr). HBsAg can be detected 2 to 4 weeks before the ALT levels become abnormal and 3 to 5 weeks before symptoms develop.
The serological detection of HBsAg is a powerful method for the diagnosis and prevention of HBV infection and ELISA has become an extensively used analytical system for screening of blood donors and clinical diagnosis of HBV in infected individuals.

For detection of HBsAg, EIAgen HBsAg Kit uses antibody “sandwich” ELISA method in which, polystyrene microwell strips are pre-coated with monoclonal antibodies specific to HBsAg. Patient’s serum or plasma sample is added to the microwells. During incubation, the specific immunocomplex formed in case of presence of HBsAg in the sample, is captured on the solid phase.
Then the second antibody conjugated the enzyme horseradish peroxidase (the HRP-Conjugate) directed against a different epitope of HBsAg is added into the wells. During the second incubation step, these HRP-conjugated antibodies will be bound to any anti-HBs-HBsAg complexes previously formed during the first incubation, and the unbound HRP-conjugate is then removed by washing. Chromogen solutions containing tetramethyl-benzidine (TMB) and urea peroxide are added to the wells. In presence of the antibody-antigen-antibody(HRP) “sandwich” immunocomplex, the colorless Chromogens are hydrolyzed by the bound HRP-conjugate to a blue-colored product. The blue color turns yellow after stopping the reaction with sulfuric acid.
The amount of color intensity can be measured and it is proportional to the amount of antigen captured in the
wells, and to its amount in the sample respectively. Wells containing samples negative for HBsAg remain colorless.

The kit contains reagents for 480 tests (code 071015).