Elecsys® HBe Ag

Immunoassay for the qualitative determination of hepatitis B e antigen (HBeAg)

Elecsys® HBe Ag

Immunoassay for the qualitative determination of hepatitis B e antigen (HBeAg)

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 90 % of the cases.1 An estimated 257 million people are living with HBV infection. In 2015, hepatitis B resulted in 887,000 deaths, mostly from complications (including cirrhosis and hepatocellular carcinoma).1

The hepatitis B e antigen (HBeAg) is a secretory protein processed from the precore protein that appears in serum as a result of HBV proliferation in acute or chronic hepatitis B. HBeAg is a marker of HBV replication and infectivity, and its presence is usually associated with higher rates of transmission.2,3

HBeAg seroconversion to anti-HBe suggests the end of active viral replication and is therefore associated with clinical resolution of self-limited hepatitis B or remission during chronic disease, marking a transition from the immune-active phase of the disease to the inactive carrier state.3-6

The HBeAg test is, therefore, meaningful in association with the anti-HBe test for monitoring the course of HBV infection and the effect of treatment for chronic hepatitis B. 3-6

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Elecsys® HBe Ag

Elecsys® HBeAg

  • Systems

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules, cobas e 801 module

  • Testing Time

    18 minutes

  • Test principle

    Sandwich assay    

  • Calibration

    2-point

  • Interpretation

     COI <1.0 = non-reactive
     COI ≥1.0 = reactive    

  • Traceability

    HBe-Reference Antigen 82 (HBeAg). 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

    35 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    21 μL cobas e 801 module

  • Onboard stability

    8 weeks for cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    16 weeks for cobas e 801 module

  • Intermediate precision in positive samples

    cobas e 411 analyzer: CV 1.7 – 4.9 %
    cobas e 601 / cobas e 602 modules CV 4.1 – 5.0 %
    cobas e 801 module CV 2.4 – 3.1 %

  • Analytical sensitivity

    ≤0.3 IU/mL    

  • Clinical specificity

    100 %

References

 

  1. WHO. Hepatitis B. Fact sheet N°204. Available at: http://www.who.int/mediacentre/factsheets/fs204/en, accessed November 2017.
  2. Kao, J.H. (2008). Diagnosis of hepatitis B virus infection through serological and virological markers. Expert Review of Gastroenterology & Hepatology 2, 553-562.
  3. Liaw, Y.F., Chu, C.M. (2009). Hepatitis B virus infection. Lancet 373, 582-592.
  4. Hoofnagle, J.H., Dusheiko, G.M., Seeff, L.B., Jones, E.A., Waggoner, J.G. and Bales, Z. B. (1981). Seroconversion from hepatitis B e antigen to antibody in chronic type B hepatitis. Ann. Intern. Med. 94, 744-748.
  5. Liaw, Y.F. (2009). HBeAg seroconversion as an important end point in the treatment of chronic hepatitis B. Hepatol Int 3, 425-433.
  6. Lampertico, P., Agarwal, K., Berg, T., Buti, M., Janssen, H.L.A., Papatheodoridis, G., Zoulim, F. and Tacke, F. (2017). EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J. Hepatol. 67, 370-398.