Hepatitis B virus infection has become a common and important public health problem worldwide. There are 350-400 million people with chronic HBV infection in the world, and 2 billion people were infected with HBV, accounting for about 6% of global population. Hepatitis B surface antigen (HBsAg) is a marker of hepatitis B virus infection. With the highest titer, HBsAg appears first in the patients with HBV, and is an important indicator for early diagnosis of hepatitis B. A positive HBsAg result indicates the presence of hepatitis B virus infection. The quantitative measurement of HBsAg is a new tool for monitoring and predicting post- treatment response to hepatitis B virus infection, thereby being of great significance both in the diagnosis of HBV infection and in the monitoring of antiviral efficacy. There is evidence that the HBsAg level combined with the HBV DNA level is helpful to identify patients without the need of treatment.

Intended Use

This product is used to quantitatively detect the hepatitis B surface antigen (HBsAg) in human serum and plasma. The assay kit is intended for in vitro diagnostic use.

Principle

This reagent is based on the double-antibody sandwich principle. Magnetic particles are coated with 4 anti-HBs murine monoclonal antibodies. The sample, reaction diluent, and magnetic microparticles are mixed for reaction, followed by washing. Then, the anti-HBs polyclonal antibody-acridinium ester-labeled complex is added so that the HBsAg in the sample and the anti-HBs antibody and anti-HBs polyclonal antibody-acridinium ester on magnetic microparticles form a complex of “magnetic microparticle anti-HBs antibody- HBsAg-antibody acridinium ester”. Then, the substances that fail to bind to magnetic microparticles are removed by washing, and pre-trigger solution and trigger solution are added to the reaction mixture. Then, the results of the chemiluminescent reaction are measured, which are expressed as relative luminous intensity (RLU). The concentration of HBsAg in the sample is positively correlated to the RLU value measured by the analyzer. The HBsAg content in the sample is calculated from the calibration curve.

Storage

The kit should be stored upright, not upside down or horizontally. Store at 2–8°C with a validity period of 12 months.

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