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Elecsys® Anti-HBc IgM

Immunoassay for the qualitative determination of IgM antibodies to hepatitis B core antigen (HBcAg)

cobas e pack

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.

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Elecsys Anti-HBc IgM

Elecsys® Anti-HBc IgM

  • Systems

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

     

  • Testing Time

    18 minutes

  • Test principle

    μ-capture assay

     

  • Calibration

    2-point

  • Interpretation

    COI <1.0 = non-reactive
    COI ≥1.0 = reactive
    1.0 COI ≈ 100 PEI-U/mL

  • Traceability

    HBc-Reference Material 84 (anti-HBc IgM). Paul-Ehrlich-Institute, Langen (Germany)

  • 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 can be used.

  • Sample volume

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

     

     

     

  • Intermediate precision in positive samples

    cobas e 411 analyzer: CV 1.8 – 3.6 %
    cobas e 601 / cobas e 602 modules CV 3.3 – 4.1 %
    cobas e 801 analytical unit, cobas e 402 analytical unit CV 3.2 – 3.4 %

  • Analytical sensitivity

    ≤3.0 PEI-U/mL

  • Clinical specificity

    100 % (n = 1,003 blood donors)
    100 % (n = 242 diagnostic samples without evidence of HBV)

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. Liaw, Y.F., Chu, C.M. (2009). Hepatitis B virus infection. Lancet 373, 582-592.
  3. Elgouhari, HM., Abu-Rajab Tamini, TI., Carey, W. Hepatitis B virus infection: understanding its epidemiology, course, and diagnosis. Cleve Clin J Med 75, 881-889.
  4. Caspari, G., Gerlick, WH. (2007). The serologic markers of hepatitis B virus infection – proper selection and standardized interpretation. Clin Lab 53, 335-343.
  5. Maruyama, T., Schodel, F., Iino, S., Koike, K., Yasuda, K., Peterson, D. and Milich, D. R. (1994). Distinguishing between acute and symptomatic chronic hepatitis B virus infection. Gastroenterology 106, 1006-1015.
  6. Kao, JH. (2008). Diagnosis of hepatitis B virus infection through serological and virological markers. Expert Review of Gastroenterology & Hepatology 2, 553-562.
  7. Elecsys® Anti-HBc IgM Package Inserts, Material numbers 07026811190 and 11820567122