Result Precision HBsAg ELISA Reagent Test Kits
Intended use
The HBsAg assay is an enzyme-linked immunosorbent assay (ELISA) for the qualitative
determination of HBsAg virus in human serum and plasma.
| Product details |
Description |
| Material |
Serum |
| Kit Size |
96 Test/Kit |
| Valid Life |
18 months |
| Brand |
BIOVANTION |
| Storage Temperature |
2-8℃ |
| package |
carton |
| In Stock |
Yes |
| Format |
HBsAg ELISA test |
Summary
The hepatitis B surface antigen (HBsAg), a polypeptide of varying size, is a component of
the external envelope of the hepatitis B virus (HBV) particle.1,2 In addition to the intact
infectious viral particles, the blood of persons infected with HBV contains large amounts of
non-infectious particles which consist only of an outer coat containing HBsAg.3 After
infection, HBsAg is the first immunological marker detectable in serum and is usually
present weeks to months before the onset of clinical symptoms and the appearance of other
biochemical markers.4 In the case of acute HBV infection with recovery, HBsAg is
detectable in serum for up to 6 months after its appearance.4 If HBsAg persists for more
than 6 months after acute hepatitis, the presence of chronic hepatitis B (CHB) infection must
be assumed. Classifying the stage of CHB infection is essential for identifying patients who
require treatment and monitoring, as well as assessing the likelihood of responding to
treatment and risk of progression to more severe liver disease.5,6,7
Test principle
Sandwich principle.Total duration of assay: 70 minutes.
The HBsAg ELISA 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 microwell together with a second antibody conjugated the
enzyme horseradish peroxidase (the HRP-Conjugate) and directed against a different
epitope of HBsAg. During incubation, the specific immunocomplex formed in case of
presence of HBsAg in the sample, is captured on the solid phase. After washing to remove
sample serum proteins and unbound HRP-conjugate, Chromogen solutions containing
tetramethyl-benzidine (TMB) and urea peroxide are added to the wells. In presence of the
antibody-antigen-antibody (HRP) “sandwich” immuno complex, 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.
Storage and stability
• Store at 2-8℃.
• Don't freeze.
• Seal and return unused reagents to 2-8℃, under which conditions the stability will be
retained for 2 months, or until the labeled expiry date, whichever is earlier.
Specimen collection and preparation
• Human serum or plasma is recommended for this assay.
• Cap and store the samples at 18-25 ℃ for no more than 8 hours. Stable for 7 days at
2-8℃, and 1 month at -20℃. Freeze only once.
• Do not use heat-inactivated samples.
• Plasma specimens collected into EDTA, sodium citrate or heparin can be tested, but
highly lipaemic, icteric, or hemolytic specimens should not be used as they can give
false results in the assay.
• Sediments and suspended solids in samples may interfere with the test result which
should be removed by centrifugation. Ensure that complete clot formation in serum
samples has taken place prior to centrifugation.
• Avoid grossly hemolytic, lipemic or turbid samples.
Wash solution (40X dilution)
Add deionized water to the 40X concentrated Wash Solution Concentrate.
Dilute 25 mL of Wash Solution Concentrate with 975 mL of deionized water to a final volume
of 1000 mL. Stable for 2 months at room temperature.
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