Hepatitis E (HEV)

Immunocompetent patient presenting with recent or current acute hepatitis

Diagnostic HEV markers and disease stages

ALT normal
anti-HEV IgM -
anti-HEV IgG -
HEV RNA (+)
Symptoms -

(…) = potentially present

ALT (elevated)
anti-HEV IgM (+)
anti-HEV IgG (+)
HEV RNA +
Symptoms (+)

(…) = potentially present

ALT elevated
anti-HEV IgM +
anti-HEV IgG +, rising
HEV RNA (+)
Symptoms +

(…) = potentially present

ALT normal
anti-HEV IgM (+)
anti-HEV IgG +
HEV RNA -
Symptoms -

(…) = potentially present

Adapted from:

  1. Aggarwal R and Goel A. Natural History, Clinical Manifestations, and Pathogenesis of Hepatitis E Virus Genotype 1 and 2 Infections. Cold Spring Harb Perspect Med. 2019;9(7):a032136.
  2. Webb GW and Dalton HR. Hepatitis E: an underestimated emerging threat. Ther Adv Infect Dis. 2019;6:1-18.
  3. Lhomme S, et al. Screening, diagnosis and risks associated with Hepatitis E virus infection. Exp Rev Anti-inf Ther. 2019;17:403-418.
  4. Kamar, N., Izopet, J., Pavio, N. et al. Hepatitis E virus infection. Nat Rev Dis Primers. 2017;3, 17086.
Product Description Tests Product page
Elecsys® Anti-HEV IgM a) Electrochemiluminescence immunoassay (ECLIA) for the qualitative detection of IgM antibodies to the hepatitis E virus (HEV) in human serum and plasma 100
Elecsys® Anti-HEV IgM b) 300
Elecsys® Anti-HEV IgG a) Electrochemiluminescence immunoassay (ECLIA) for the quantitative determination of IgG antibodies to the hepatitis E virus (HEV) in human serum and plasma 100
Elecsys® Anti-HEV IgG b) 300
cobas® HEV c) Qualitative in vitro nucleic acid amplification test for the direct detection of HEV RNA (genotypes 1-4) in human plasma 96

a) for use on the cobas® e 411 analyzer and the cobas® e 601 / 602 modules;
b) for use on the cobas® e 402 and cobas® e 801 analytical units
c) intended for use to screen donor samples for HEV RNA in plasma samples from individual human donors, including donors of whole blood, blood components (red cells, platelets, and plasma), and other living donors; not intended for use as an aid in diagnosis for HEV; for use on the cobas® 6800/8800 Systems

Adapted from:

  1. Kar, P, Karna R. A Review of the Diagnosis and Management of Hepatitis E. Curr Treat Options Infect Dis. 2020;12:310–320.
  2. Aslan AT, Balaban HY. Hepatitis E virus: Epidemiology, diagnosis, clinical manifestations, and treatment. World J Gastroenterol. 2020;26:5543-5560.
  3. Public Health England. Public health operational guidelines for hepatitis E. Health protection response to reports of hepatitis E infection. 2019 Guidelines. Internet [updated 2019 Sep; cited 2023 May]. ​​​​​​​Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/845090/Public_Health_Operational_Guidelines_for_Hepatitis_E-protection_response.pdf.
  4. Lhomme S, et al. Screening, diagnosis and risks associated with Hepatitis E virus infection. Exp Rev Anti-inf Ther. 2019;17:403-418.
  5. European Association for the Study of the Liver (EASL). Clinical Practice Guidelines on hepatitis E virus infection. J Hepatol 2018;68:1256-1271.
  • Step 1
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Step 1

Perform anti-HEV IgM and

anti-HEV IgG tests in parallel

anti-HEV IgM
anti-HEV IgG
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Step 2

Perform HEV RNA test

HEV RNA
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Step 3

Perform HEV RNA test

HEV RNA
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Summary

Past HEV infection

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Summary

No evidence of HEV infection

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Summary

Current acute HEV infection
Advise to maintain good personal hygiene to minimize spread of the infection. For management of infected patients (especially at-risk groups like patients with underlying chronic liver disease or pregnant women), refer to clinical practice guidelines.

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Summary

Recent acute HEV infection
For management of infected patients (especially at-risk groups like patients with underlying chronic liver disease or pregnant women), refer to clinical practice guidelines.

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Summary

Early acute HEV infection
Advise to maintain good personal hygiene to minimize spread of the infection. For management of infected patients (especially at-risk groups like patients with underlying chronic liver disease or pregnant women), refer to clinical practice guidelines.

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Summary

No acute HEV infection
Anti-HEV IgM reactivity alone is not diagnostic of acute HEV infection.

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Next Restart simulation
Step
Result
Interpretation
1

anti-HEV IgM test = ...
​​​​​​​anti-HEV IgG test = ...

waiting for input
1
anti-HEV IgM test = ...
anti-HEV IgG test = positive
waiting for input
1
anti-HEV IgM test = ...
anti-HEV IgG test = negative
waiting for input
1
anti-HEV IgM test = positive
anti-HEV IgG test = ...
waiting for input
1
anti-HEV IgM test = negative
anti-HEV IgG test = ...
waiting for input
1

anti-HEV IgM test = positive
anti-HEV IgG test = positive

Acute or recent HEV infection.
​​​​​​​Perform HEV RNA test to confirm the stage of acute HEV infection.

1
anti-HEV IgM test = positive
anti-HEV IgG test = negative
Possible acute HEV infection.
Perform HEV RNA test to confirm acute HEV infection.
1
anti-HEV IgM test = negative
anti-HEV IgG test = positive
Past HEV infection.
1
anti-HEV IgM test = negative
anti-HEV IgG test = negative
No evidence of HEV infection.
2
HEV RNA test = ...
waiting for input
2
HEV RNA test = positive
Current acute HEV infection.
2
HEV RNA test = negative
Recent acute HEV infection
2
HEV RNA test = ...
waiting for input
2
HEV RNA test = positive
Early acute HEV infection
2
HEV RNA test = negative
No acute HEV infection
End of test sequence