Hepatitis B Virus Pre-S1 Antigen ELISA Kit

Short Description:

Hepatitis B virus (HBV) pre-S1 antigen (Pre-S1) is a component of the viral envelope large surface protein, expressed predominantly during active viral replication. It appears in the earliest phase of HBV infection, often detectable in serum shortly after HBV DNA and before or concurrently with HBsAg, making it a sensitive marker of ongoing viral replication and infectivity.

In acute hepatitis B, Pre-S1 typically becomes positive during the incubation period and early symptomatic phase. Its early clearance (negative conversion) correlates with viral clearance and a favorable prognosis, often preceding HBeAg seroconversion and resolution of infection. Persistent positivity of Pre-S1 antigen is strongly associated with progression to chronic infection, reflecting sustained viral replication.

Pre-S1 detection serves as a valuable supplementary marker to HBeAg in assessing HBV replicative activity. Unlike HBeAg, which may become negative during seroconversion to anti-HBe (even in the presence of ongoing replication due to precore/core promoter mutations), Pre-S1 remains positive in many such cases, providing additional information on viral activity. It is particularly useful in monitoring treatment response in chronic hepatitis B patients, where decline or disappearance of Pre-S1 often indicates effective suppression of viral replication. Overall, Pre-S1 antigen testing enhances the diagnostic and prognostic evaluation of HBV infection, especially when combined with other serological and molecular markers.

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Principle:

This kit employs the double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) principle for the qualitative detection of hepatitis B virus pre-S1 antigen (HBV Pre-S1 Ag) in human serum or plasma samples. The polystyrene microwell strips are pre-coated with monoclonal antibodies specific for HBV Pre-S1 antigen (capture antibodies). Upon addition of the serum or plasma specimen, any Pre-S1 antigen present in the sample binds specifically to the immobilized capture antibodies during incubation. Unbound components are subsequently removed by washing. In the next step, horseradish peroxidase (HRP)-conjugated antibodies (typically anti-HBs or anti-Pre-S1 detection antibodies) are added, which bind to different epitopes on the captured Pre-S1 antigen, forming a (capture Ab) - Pre-S1 Ag - (HRP-detection Ab) sandwich complex. Following a wash step to remove unbound HRP conjugates, a chromogenic substrate (TMB) is added to the wells. In the presence of the immunocomplex, the HRP enzyme catalyzes the substrate reaction, producing a blue color proportional to the amount of captured Pre-S1 antigen. The reaction is terminated by adding a stop solution (typically 50 μL per well), which changes the color to yellow. The absorbance (optical density) is then measured using a microplate reader at the appropriate wavelength (e.g., 450 nm, with a reference wavelength of 620-690 nm if required) to determine the presence or absence of HBV Pre-S1 antigen in the sample.

Product Features:

High sensitivity, specificity and stability

Product Specification:

Principle	Enzyme linked immunosorbent assay
Type	Double-antibody Sandwich
Certificate	NMPA
Specimen	Human serum / plasma
Specification	48T / 96T
Storage temperature	2-8℃
Shelf life	12 months