Recombinant Hepatitis B Core Antigen for immunoassay development and manufacturing

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 cancer¹.

According to the latest data from the World Health Organization 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 Core Antigen (anti-HBc) test detects antibodies directed against the hepatitis B core antigen in blood samples. A positive total anti-HBc result indicates past or present exposure to the HBV, unlike anti-HBs, it does not appear following vaccination and therefore always reflects natural infection. 

• Uncovering past or present infection: Total anti-HBc positivity can reveal chronic or previously resolved infection even in cases where HBsAg has already cleared from circulation.
• Staging the disease: When interpreted alongside HBsAg and anti-HBs, IgM anti-HBc helps clinicians reliably differentiate acute from chronic hepatitis B, directly informing treatment decisions.
• Enabling universal screening: The CDC's 2023 updated recommendations include total anti-HBc as part of the recommended triple-marker panel (HBsAg, anti-HBs, and total anti-HBc) for all adults aged 18 and older, at least once in their lifetime³ .

How Werfen can support you 

We can help secure the supply chain of your Anti-HBc immunoassay with our recombinant Hepatitis B Core Antigen (HBcAg)

Contact us for further information on product availability and development stage

Check our technical note (on our Recombinant HBc Antigen when used in a chemiluminescence prototype for the qualitative detection of antibodies to Hepatitis B Virus Core antigen.

1. Hepatitis B Fact Sheet. World Health Organization. July 2025. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b Accessed May 2026

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

3. Clinical Testing and Diagnosis for Hepatitis B. U.S Centers for Disease Control and Prevention. Jan 2025. https://www.cdc.gov/hepatitis-b/hcp/diagnosis-testing/?CDC_AAref_Val=https://www.cdc.gov/hepatitis/hbv/testingchronic.htm Accessed May 2026