Hepatitis C (HCV)

Suspected chronic HCV infection / HCV screening

Diagnostic HCV markers and disease stages

ALT elevated
anti-HCV -
HCV RNA +
Symptoms +
ALT elevated
anti-HCV (+)
HCV RNA +
Symptoms +
ALT elevated
anti-HCV +
HCV RNA +
Symptoms (+)

Adapted from:

  1. Dufour DR, et al. Diagnosis and monitoring of hepatic injury. I. Performance characteristics of laboratory tests. Clin Chem. 2001;46:2027-49.
  2. Hoofnagle JH. Course and Outcome of Hepatitis C. Hepatology. 2002;36:S21-S29.
  3. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Viral Hepatitis Serology Training, Hepatitis C. [Internet; updated 2015 Nov 25; cited 2024 Mar 4]. Available from: https://www.cdc.gov/hepatitis/resources/professionals/training/serology/training.htm.
  4. World Health Organization (WHO). Guidelines on Hepatitis B and C Testing. Fig. 1, Approximate time course for HCV virological and serological markers in chronic HCV infection. [Internet; updated 2017 Feb; cited 2024 Mar 4]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK442283/figure/annex6.fig1/.
  5. Manns MP, et al. Hepatitis C virus infection. Nat Rev Dis Prim. 2017;3:17006.
  6. Ahmad J. Hepatitis C. BMJ. 2017;358:j2861.
  7. Austria A and Wu GY. Occult Hepatitis C Virus Infection: A Review. J Clin Transl Hepatol. 2018;6:155-160.
Product Description Tests Product page
Elecsys® Anti-HCV II a) Qualitative detection of antibodies to HCV in human serum and plasma 100
Elecsys® Anti-HCV II a) 200
Elecsys® Anti-HCV II b) 300
Elecsys® HCV Duo b) Qualitative detection of HCV core antigen and antibodies to HCV in human serum and plasma 300
cobas® HCV c) Detection and quantitation of HCV RNA in human EDTA plasma or serum 192
cobas® HCV d) 120
cobas® HCV GT d) Qualitative identification of HCV genotypes 1 to 6 and genotype 1 subtypes a and b in human plasma or serum 120

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
d) for use on the cobas® 4800 System

* For persons who might have been exposed to HCV within the past 6 months, testing for HCV RNA or follow-up testing for HCV antibody is recommended.2
** Repeat HCV RNA testing 12 and 24 weeks later to confirm definitive clearance and if the person tested is suspected to have had HCV exposure within the past 6 months or has clinical evidence of HCV disease, or if there is concern regarding the handling or storage of the test sample.1,2
*** If an HCV core antigen test is used to assess viremia, antibody-positive samples that test negative for HCV core antigen should have a confirmatory HCV RNA test to exclude a false negative core antigen result.3

Adapted from:

  1. European Association for the Study of the Liver (EASL). Recommendations on treatment of hepatitis C: Final update of the series. J Hepatol. 2020;73:1170-1218.
  2. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC). Testing for HCV Infection: An Update of Guidance for Clinicians and Laboratorians. MMWR. 2013;62:362-65.
  3. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (AASLD-IDSA). Recommendations for testing, managing, and treating hepatitis C. [Internet; updated 2023 Dec, cited 2024 Mar 4]. Available from: http://www.hcvguidelines.org.
  4. Manns MP, et al. Hepatitis C virus infection. Nat Rev Dis Prim. 2017;3:1700
  5. World Health Organization (WHO). Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C virus infection. [Internet; updated 2018 Jul 1; cited 2024 Mar 4]. Available from: https://www.who.int/publications/i/item/9789241550345.
  • Step 1
  • Step 2
  • Step 3
Step 1

Perform anti-HCV test

anti-HCV
  • Step 1
  • Step 2
  • Step 3
Step 2

Perform HCV RNA or core antigen test

Perform HCV RNA or core antigen test
  • Step 1
  • Step 2

Summary

No indication of HCV infection.

However, the possibility of exposure to HCV cannot be excluded.
For persons who might have been exposed to HCV within the past 6 months, testing for HCV RNA or follow-up testing for HCV antibody is recommended. For persons who are immunocompromised, testing for HCV RNA can be considered.

  • Step 1
  • Step 2
  • Step 3

Summary

No current HCV infection, but indication of previous exposure

Repeat HCV RNA or core antigen testing 12 and 24 weeks later to confirm definitive clearance and if the person tested is suspected to have had HCV exposure within the past 6 months or has clinical evidence of HCV disease, or if there is concern regarding the handling or storage of the test sample.

  • Step 1
  • Step 2
  • Step 3

Summary

Current (active) HCV infection

Provide person tested with appropriate counseling and link person tested to care and treatment. Consider follow-up quantitative HCV RNA and HCV genotype testing, as per current HCV treatment guidelines.

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Next Restart simulation
Step
Result
Interpretation
1
anti-HCV test = ...
waiting for input
1
anti-HCV test = negative
anti-HCV negative
No HCV infection
1
anti-HCV test = positive

Presumptive HCV infection

​​​​​​​Perform HCV RNA or HCV core antigen test to confirm an active HCV infection.

2
HCV RNA test or core antigen test = ...
waiting for input
2
HCV RNA test or core antigen test = negative

No current HCV infection, but indication of previous exposure

Additional testing as appropriate.

If an HCV core antigen test is used to assess viremia, antibody-positive samples that test negative for HCV core antigen should have a confirmatory HCV RNA test to exclude a false negative core antigen result.

2
HCV RNA test or core antigen test = positive

Current (active) HCV infection

End of test sequence