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Elecsys® Anti-HBc II

Immunoassay for the qualitative determination of total antibodies against hepatitis B core antigen (HBcAg)

cobas e pack

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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Elecsys® Anti-HBc II

Elecsys® Anti-HBc II

  • Systems

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules,
    cobas e 801 analytical unit, cobas e 402 analytical unit

  • Testing Time

    27 minutes

  • Test principle

    2-step competitive assay with pretreatment

     

  • Calibration

    2-point

  • Interpretation

    COI >1.0 = non-reactive
    COI ≤1.0 = reactive

  • Traceability

    Anti-HBc reference material WHO standard (NIBSC code 95/522)

  • Sample material

    Serum collected using standard sampling tubes or tubes containing separating gel. Li‑heparin, Na‑heparin, K2‑EDTA, K3‑EDTA, ACD, CPD, CP2D, CPDA and Na‑citrate plasma. Plasma tubes containing separating gel.

  • Sample volume

    40 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    24 μL cobas e 801 analytical unit, cobas e 402 analytical unit

  • Intermediate precision in positive samples

    cobas e 411 analyzer:  CV 3.6 - 4.4 %
    cobas e 601 / cobas e 602 modules: CV 4.0 - 4.8 %
    cobas e 801 analytical unit, cobas e 402 analytical unit: CV 2.2 - 3.1 %

  • Clinical sensitivity

    100 % (n = 793 samples from HBV infected patients in different stages of the disease)

  • Analytical sensitivity

    ≤0.8 WHO IU/mL

  • Clinical specificity

    100 % (n = 997; diagnostic routine / hospitalized patients)
    99.93 % (n = 8,163; blood donors – serum)
    99.88 % (n = 9,162; blood donors – plasma)
    99.31 % (n = 779; dialysis patients)
    100 % (n = 1,000; pregnant women)

References

  1. WHO. Hepatitis B Fact sheet. Latest update: 2 June 2022. Available at: https://www.who.int/en/news-room/fact-sheets/detail/hepatitis-b, accessed January 2023.
  2. Seeger, C., Zoulim, F., Mason, W.S. (2007). Hepadnaviruses. In: Field’s Virology, Knipe DM, Howley RM (eds), 5th edition, Lippincott Williams and Wilkins, Philadelphia, USA. Chapter 76, 2977-3029.
  3. Liang, T.J. (2009). Hepatitis B: the virus and disease. Hepatology 49(5 Suppl), 13-21.
  4. Krajden, M., McNabb, G., Petric, M. (2005). The laboratory diagnosis of hepatitis B virus. Can J Infect Dis Med Microbiol. 16(2), 65-72.
  5. Centers for Disease Control and Prevention (CDC). Interpretation of Hepatitis B Serologic Test Results. Available at: https://www.cdc.gov/hepatitis/hbv/pdfs/serologicchartv8.pdf, accessed January 2023.
  6. Liaw, Y.F., Chu, C.M. (2009). Hepatitis B virus infection. Lancet 373, 582-592.
  7. lgouhari, H.M., Abu-Rajab, Tamini, T.I., Carey, W. (2008). Hepatitis B virus infection: understanding its epidemiology, course, and diagnosis. Cleve Clin J Med. 75, 881-889.
  8. Caspari, G., Gerlick, W.H. (2007). The serologic markers of hepatitis B virus infection – proper selection and standardized interpretation. Clin Lab. 53, 335-343.
  9. Pondé, R.A., Cardoso, D.D., Ferro, M.O. (2010). The underlying mechanisms for the ‘anti-HBc alone’ serological profile. Arch Virol. 155, 149-158.
  10. Elecsys® Anti-HBc II Package Inserts Material numbers 09014918190 09109463190 09014926190