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 192

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) for use on the cobas® 5800/6800/8800 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.

  • Step 1
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  • Step 3

Summary

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

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