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Elecsys® Anti-HAV IgM

Immunoassay for the qualitative determination of IgM-antibodies to HAV

Elecsys® Anti-HAV IgM

Immunoassay for the qualitative determination of IgM-antibodies to 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 

An acute hepatitis A infection can be assumed if anti-HAV IgM antibodies are detected.6 Anti-HAV IgM antibodies can be detected in the serum within 2 weeks after the initial HAV infection and usually disappear 3 to 4 months later, although anti-HAV IgM can also be detected in some patients for a longer period of time.7,8 Anti-HAV IgM antibodies develop only very rarely after vaccination.9 Assays to detect anti-HAV IgM antibodies are used in the differential diagnosis of acute hepatitis to determine a hepatitis A infection.

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Elecsys® Anti-HAV IgM

Elecsys® Anti-HAV IgM

  • Systems

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

  • Testing Time

    18 minutes

  • Test principle

    μ-capture assay

  • Calibration

    2-point

  • Interpretation

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

  • Traceability

    Roche reference standard

  • Sample material

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

    cobas e 801 module: Serum collected using standard sampling tubes or tubes containing separating gel. Li-heparin, Na-heparin, K2-EDTA, K3-EDTA and Na-citrate plasma.

  • Sample volume

    10 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    6 μL cobas e 801 module

  • Onboard stability

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

  • Intermediate precision in positive samples

    cobas e 411 analyzer: CV 2.7 – 5.4 %
    cobas e 601 / cobas e 602 modules: CV 2.6 – 7.9 %
    cobas e 801 module: CV 2.0 – 5.3 %

  • Clinical sensitivity

    100 % (n = 211)

  • Clinical specificity

    100 % (n = 1,312)

References

 

  1. Lemon, S.M., Ott, J.J., Van Damme, P.V., Shouval, D. (2017). 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-EUEEA-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. Lemon, S.M., Brown, C.D., Brooks, D.S., Simms, T.E., Bancroft, W.H. (1980). Specific immunoglobulin M response to hepatitis A virus determined by solidphase radioimmunoassay. Infect Immun 28, 927-936.
  7. Cuthbert, J.A. (2001). Hepatitis A: Old and New. Clin. Microbiol. Rev. 14(1), 38-58.
  8. Stapleton, J.T. (1995). Host immune response to hepatitis A virus. J Infect Dis 171, 9-14.
  9. Sjogren, M.H., Hoke, C.H., Binn, L.N., Eckels, K.H., Dubois, D.R., Lyde, L. et al. (1991). Immunogenicity of an inactivated hepatitis A vaccine. Ann Intern Med 114, 470-1.