Immunoassay for the qualitative determination of total antibodies against hepatitis B core antigen (HBcAg)
Hepatitis B is a potentially life threatening liver infection caused by the hepatitis B virus (HBV). It is transmitted through contact with the blood or other body fluids of an infected person.1 The disease is not always self limiting: In adults approx. 5 % of acute infections will follow a chronic course of varying degrees of severity; infants will develop chronic hepatitis B in up to 95 % of the cases.1
Approximately 300 million people are estimated to be living with HBV Infection. In 2019, hepatitis B resulted in an estimated 820 000 deaths, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer).1
The hepatitis B virus (HBV) consists of an external envelope (HBsAg) and an inner core (HBcAg). The hepatitis core antigen comprises 183 – 185 amino acids.2 During an infection with HBV, antibodies to HBcAg (anti-HBc) are generally formed soon after the appearance of HBsAg, the initial antibody being mostly IgM class, which then declines in titer as levels of anti-HBc IgG start increasing.3 Anti-HBc (total) positivity persists in persons who have recovered from HBV infection and in those who progress to chronic HBV infection.4,5 Accordingly, they are an indicator of existing or past HBV infection.6 In rare cases, HBV infection can also run its course without the appearance of immunologically detectable anti-HBc (usually in immunosuppressed patients).8 Anti-HBc is not produced after vaccination.5,8
Due to the persistence of anti-HBc following HBV infection, screening for anti-HBc can be used to identify previously infected individuals.1 Determination of anti-HBc in association with other hepatitis B tests permits the diagnosis and monitoring of HBV infections.4,5 In the absence of other hepatitis B markers (HBsAg-negative persons), anti-HBc may be the only indication of an existing HBV infection.6,9
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