Elecsys® Anti-HAV

Immunoassay for the quantitative determination of total antibodies against HAV

Elecsys® Anti-HAV

Immunoassay for the quantitative determination of total antibodies against HAV

Hepatitis A virus (HAV) is one of the more common causes of acute hepatitis, infecting an estimated 1.5 million people annually.1 It is transmitted by the fecal-oral route.2 The incubation period ranges between 15 – 50 days.3 In high endemic countries HAV outbreaks generally occur in crowded institutions such as prisons or schools. In low endemic countries infected food handlers are the major source of the infection.4 

The disease has not been known to follow a chronic course, nor does the virus persist in the organism.5 Anti-HAV IgM antibodies can be detected in the serum within 2 weeks after the initial HAV infection.6 After natural infection, the patient usually acquires lifelong immunity and anti-HAV IgG antibodies can be detected, providing protection against the disease if the body is reinfected.7 

Vaccines against hepatitis A and combined vaccines against hepatitis A and B are available. After vaccination against hepatitis A, anti-HAV IgG antibodies can be detected within 2 weeks.8 In the case of complete immunization, protection usually lasts for years.9 

The Elecsys® Anti-HAV test is an immunoassay for the quantitative determination of total (IgM and IgG) antibodies to HAV in human serum and plasma. It is used as an aid to detect a past or existing HAV infection and also to monitor the immune response after vaccination.

Elecsys® Anti-HAV

Elecsys® Anti-HAV

  • Systems

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

  • Testing Time

    18 minutes

  • Test principle

    Inverted 2-step competitive assay

  • Calibration

    2-point

  • Interpretation

    <20 IU/L = non-reactive
    ≥20 IU/L = reactive

  • Traceability

    Second International Standard for Anti-Hepatitis A, Immunoglobulin, Human, NIBSC code: 97/646” of the NIBSC

  • Sample material

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules: Serum collected using standard sampling tubes or tubes containing separating gel. K3-EDTA and Na-citrate plasma.

    cobas e 801 module: Serum collected using standard sampling tubes or tubes containing separating gel.

  • Sample volume

    50 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    30 μL cobas e 801 module

  • Onboard stability

    7 days cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    16 weeks cobas e 801 module

  • Measuring range

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules: 3.0 – 60 IU/L
    cobas e 801 module: 4.0 – 60 IU/L

  • Intermediate precision in positive samples

    cobas e 411 analyzer: CV 2.8 – 4.0 %
    cobas e 601 / cobas e 602 modules: CV 1.6 – 3.0 %
    cobas e 801 module: CV 1.6 – 3.0 %

  • Relative clinical sensitivity (compared with a commercially available assay)

    100 % (n = 97 IgM, 165 IgG)

  • Clinical specificity

    98.95 % (n = 1,301) 

References

 

  1. Lemon, S.M., Ott, J.J., Van Damme, P.V. (2017). Shouval D. Type A viral hepatitis: A summary and update on the molecular virology, epidemiology, pathogenesis and prevention. J Hepatol 68(1), 167-84.
  2. Lemon, S.M. (1985). Type A viral hepatitis. New developments in an old disease. N Engl J Med 313, 1059-1067.
  3. European Centre for Disease Prevention and Control (ECDC). Hepatitis A virus in the EU/EEA, 1975–2014. ECDC technical report. Stockholm: ECDC. 2016. Available from: http://ecdc.europa.eu/en/publications/Publications/hepatitis-a-virus-EU-EEA-1975-2014.pdf
  4. Fiore, A.E. (2004). Hepatitis A transmitted by food. Clin Infect Dis 38(5), 705-15.
  5. Leman, S.M. and Binn, L.N. (1983). Serum neutralizing antibody response to hepatitis A virus. J Infect Dis 148(6), 1033-39.
  6. Cuthbert, J.A. (2001). Hepatitis A: Old and New. Clin. Microbiol. Rev. 14(1), 38-58.
  7. Hadem, J. and Manns, M.P. (2007). Immune Response to Hepatitis A and E Viruses. Role in Disease Pathogenesis and Viral Elimination. In: Gershwin ME, Manns MP, Vierling JM, SpringerLink (Online service), editors. Liver Immunology Principles and Practice. Totowa, NJ: Humana Press Inc.,163-77.
  8. Nothdurft, H.D. (2008). Hepatitis A vaccines. Expert Rev Vaccines 7(5), 535-45.
  9. Ott, J.J., Irving, G., Wiersma, S.T. (2012). Long-term protective effects of hepatitis A vaccines: A systematic review. Vaccine 31(1), 3-11.