News Immunoassay

New Recombinant Hepatitis B Surface Antigen AY subtype for immunoassay development and manufacturing

Securing your supply chain

September 15, 2025

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Hepatitis B is a major global public health issue, marked by inflammation of the liver due to infection with the Hepatitis B virus (HBV). Disease can manifest as both acute and chronic hepatitis, and chronic infection can lead to serious complications, including cirrhosis and liver cancer[1].

According to the latest data from the World Health Organization (WHO), an estimated 254 million people are living with chronic Hepatitis B infection worldwide as of 2022. Each year, there are approximately 1.2 million new infections globally. In 2022, HBV infection led to about 1.1 million deaths, primarily from complications such as cirrhosis and hepatocellular carcinoma[1]-[2].

Diagnosis of Hepatitis B involves serological testing for various markers. The anti-Hepatitis B Surface Antigen (anti-HBs) test specifically detects antibodies against the Hepatitis B surface antigen in blood samples. A positive anti-HBs result confirms that an individual is immune to Hepatitis B: this immunity could be due to prior vaccination or from having recovered from an earlier infection.

Anti-HBs testing is routinely recommended as part of diagnostic panels to:

  • Confirm immunity—either from vaccination or previous infection.
  • Distinguish between susceptible, immune, and infected states when interpreted alongside other tests (such as HBsAg and anti-HBc).
  • Guide booster vaccination decisions when antibody levels are low.


How Werfen can support you 

We can help to secure the supply chain of your anti-HBs immunoassay with our recombinant Hepatitis B Surface Antigen ay subtype. 

Biomaterial

PN

Product Description

Antigen

3000-7069

Recombinant HBsAg ay

Contact us for further information on product availability and development stage

Using the newly engineered recombinant HBsAg ay, our R&D team developed a CLIA prototype for qualitative anti-HBs detection in human serum and conducted a head-to-head comparison with native HBsAg ay in the same assay format to evaluate performance. Read the full technical note here.


[1] Hepatitis B Fact Sheet. World Health Organization. July 2025. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b Accessed July 2025

[2] Hepatitis B Key Figures. World Health Organization. https://www.who.int/data/gho/data/themes/chronic-viral-hepatitis Accessed July 2025


 

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