Immunoassay for the qualitative determination of IgM antibodies to 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 core antigen (HBcAg) cannot be detected in the serum, but antibodies against it appear soon after the hepatitis B surface antigen (HBsAg) appears in the serum, and can be detected throughout the course of HBV infection.2,3
Anti‑HBc IgM antibodies usually persist for up to 6 months, being then replaced by anti‑HBc IgG antibodies, which may persist for life.3,4 Anti-HBc IgM titers may increase to detectable levels during exacerbations of chronic hepatitis B.5,6 Tests for detecting anti‑HBc IgM antibodies are used, in conjunction with HBsAg determinations, to identify acute hepatitis B.