Hepatitis B (HBV)

Suspected chronic HBV infection

2017 EASL nomenclature Previous naming convention
Phase 1 HBeAg positive chronic HBV infection non-inflammatory or
immune-tolerant phase
Phase 2 HBeAg positive chronic hepatitis B non-inflammatory or
immune-reactive phase
Phase 3 HBeAg negative chronic HBV infection inactive carrier phase
Phase 4 HBeAg negative chronic hepatitis B reactivation or
immune escape phase
Phase 5 Occult HBV infection (OBI)
Phase 1 Phase 2 Phase 3 Phase 4 Phase 5
ALT Normal Elevated Normal Fluctuating Normal
HBsAg High High Low Intermediate Undetectable
HBeAg Detectable (Detectable) Undetectable (Detectable) Undetectable
anti-HBe Undetectable (Detectable) Detectable (Detectable) (Detectable)
HBV DNA* High Fluctuating Low Fluctuating Low or undetectable
(...) = potentially present / * in serum/plasma

Adapted from:

  1. Fourati S and Pawlotsky JM. Recent advances in understanding and diagnosing hepatitis B virus infection. F1000Res. 2016;5:F1000 Faculty Rev-2243.
  2. Mauss S, Berg T, Rockstroh J, Sarrazin C, and Wedemeyer H. Hepatology - A clinical textbook (10th ed.). Medizin Fokus Verlag;2020. [Internet; cited 2023 Nov 14]. Available from: https://www.hepatologytextbook.com/.
  3. Liaw YF, Chu CM. Hepatitis B virus infection. Lancet. 2009;373:582-592.
  4. Davison SA and Strasser SI. Ordering and interpreting hepatitis B serology. BMJ. 2014;348: g2522.
  5. Shiffman ML. Management of Acute Hepatitis B. Clin Liv Dis. 2010;14:75-91.
  6. ARUP Consult. Hepatitis B Virus Testing. [Internet; updated 2020 Feb; cited 2023 Nov 14]. Available from: https://arupconsult.com/sites/default/files/Hepatitis%20B%20Virus%20Testing%20algorithm.pdf.
Product Description Tests Product page
Elecsys® Anti-HBc IgM a) Electrochemiluminescence immunoassay (ECLIA) for the qualitative detection of IgM class antibodies to the hepatitis B core antigen (HBcAg) in human serum and plasma 100
Elecsys® Anti-HBc IgM b) 300
Elecsys® Anti-HBc II a) Electrochemiluminescence immunoassay (ECLIA) for the qualitative detection of IgM and IgG class antibodies to the hepatitis B core antigen (HBcAg) in human serum and plasma 100
Elecsys® Anti-HBc II b) 300
Elecsys® Anti-HBe a) Electrochemiluminescence immunoassay (ECLIA) for the qualitative detection of total antibodies to the hepatitis B e antigen (HBeAg) in human serum and plasma 100
Elecsys® Anti-HBe b) 300
Elecsys® HBeAg a) Electrochemiluminescence immunoassay (ECLIA) for the qualitative detection of the hepatitis B e antigen (HBeAg) in human serum and plasma 100
Elecsys® HBeAg b) 300
Elecsys® HBeAg quant a) Immunoassay for the in vitro qualitative and quantitative determination of hepatitis B e antigen (HBeAg) in human serum and plasma. 100
Elecsys® HBeAg quant b) 300
Elecsys® Anti-HBs II a) Electrochemiluminescence immunoassay (ECLIA) for the quantitative determination of antibodies to the hepatitis B surface antigen (HBsAg) in human serum and plasma 100
Elecsys® Anti-HBs II b) 300
Elecsys® HBsAg Confirmatory Test a) b) Electrochemiluminescence immunoassay (ECLIA) for the qualitative detection of the hepatitis B surface antigen (HBsAg) in human serum and plasma
Elecsys® HBsAg II Auto Confirm b) Electrochemiluminescence immunoassay (ECLIA) for the confirmation of presence of the hepatitis B surface antigen (HBsAg) in human serum and plasma 100
Elecsys® HBsAg II quant II a) Electrochemiluminescence immunoassay (ECLIA) for the quantitative determination of the hepatitis B surface antigen (HBsAg) in human serum and plasma 100
Elecsys® HBsAg II quant II b) 100
cobas® HBV c) Nucleic acid amplification test for the quantitative measurement of HBV DNA in human EDTA plasma 120
cobas® HBV d) 96
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® 4800 System
d) for use on the cobas® 6800/8800 Systems

Adapted from:

  1. Elgouhari HM, et al. Hepatitis B virus infection: understanding its epidemiology, course, and diagnosis. Cleve Clin J Med 2008;75:881-889
  2. Fourati S and Pawlotsky JM. Recent advances in understanding and diagnosing hepatitis B virus infection. F1000Res 2016;5:F1000 Faculty Rev-2243.
  3. Lok AS, et al. Hepatitis B cure: From discovery to regulatory approval. J Hepatol 2017;67:847-861.
  4. European Association for the Study of the Liver (EASL). Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017;67:370-398.
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Step 1

Perform repeat HBsAg tests within 6 weeks

HBsAg test
  • Step 1
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Step 2

Perform HBsAg confirmatory test

HBsAg confirmatory test
  • Step 1
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  • Step 4
Step 3

Perform anti-HBc and anti-HBc IgM tests

anti-HBc test
anti-HBc IgM test
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  • Step 4

Summary

No chronic HBV infection
In rare cases, the absence of HBsAg could be related to the sensitivity of the test used for detection, either in therms of analytical sensitivity or variant detection.

Consider testing for anti-HBs and anti-HBc to determine immunity to HBV in case of anti-HBc-only reactive, consider/monitor potential risk of reactivation (e.g. in case of immunosuppression).

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Summary

Non-specific HBsAg reactivity
Consider testing other markers (anti-HBs, anti-HBc IgM, anti-HBc, HBeAg, anti-HBe, HBV DNA)

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Summary

Uncertain status, further testing required
Perform quantitative HBsAg, HBeAg (quant), anti-HBe, and HBV DNA test to clarify phase of infection and whether to treat.

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Summary

Early infection
Perform quantitative HBsAg, HBeAg (quant), anti-HBe, and HBV DNA test to clarify phase of infection and whether to treat.

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Summary

Non-recent infection
Perform quantitative HBsAg, HBeAg (quant), anti-HBe, and HBV DNA test to clarify phase of infection and whether to treat.

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Summary

Recent infection of exacerbation of chronic disease
Perform quantitative HBsAg, HBeAg (quant), anti-HBe, and HBV DNA test to clarify phase of infection and whether to treat.

Back
Next Restart simulation
Step
Result
Interpretation
1
HBsAg test = ...
waiting for input
1
HBsAg test = negative (repeatedly non-reactive)
No chronic HBV infection.
1
HBsAg test = positive (repeatedly reactive)

Presumed ongoing infection.

2
HBsAg confirmatory test = ...
waiting for input
2
HBsAg confirmatory test = negative

Non-specific HBsAg reactivity.

2
HBsAg confirmatory test = positive
Infection with HBV confirmed.

Perform anti-HBc and anti-HBc IgM tests.
3
anti-HBc test = ...
anti-HBc IgM test = ...
waiting for input
3
anti-HBc test = negative
anti-HBc IgM test = negative
Uncertain status, further testing required.
3
anti-HBc test = negative
anti-HBc IgM test = positive

Presumed early infection.

3
anti-HBc test = positive
anti-HBc IgM test = negative

Presumed non-recent infection.

3
anti-HBc test = positive
anti-HBc IgM test = positive
Recent infection or exacerbation of chronic disease.
End of test sequence