Hepatitis C (HCV)

Suspected acute HCV infection

Diagnostic HCV markers and disease stages

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

(…) = potentially present

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

* If the clinical signs and symptoms are compatible with an acute hepatitis (ALT level >10 times the upper limit of normal and/or jaundice), in the absence of a history of chronic liver disease or other causes of acute hepatitis, and/or if a likely recent source of transmission is identifiable.1

** 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
  • Step 1
  • Step 2
Step 1

Perform anti-HCV test and
HCV RNA or HCV core antigen test

anti-HCV
HCV RNA or HCV core antigen
  • Step 1
  • Step 2

Summary

Current (active) HCV infection
Provide person tested with appropriate counseling and link person tested to medical care and treatment.

  • Step 1
  • Step 2

Summary

Current (active) HCV infection
Provide person tested with appropriate counseling and link person tested to medical care and treatment.

  • Step 1
  • Step 2

Summary

No indication of current (active) HCV infection
HCV RNA-negative or HCV core antigen-negative individuals should be retested for HCV RNA or HCV core antigen 12 and 24 weeks after a negative result to confirm definitive clearance.

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.

  • Step 1
  • Step 2

Summary

No current HCV infection
No laboratory evidence of current HCV infection, although a previous exposure cannot be completely excluded. Additional HCV testing is typically unnecessary. Testing can be repeated when there is a high index of suspicion for recent infection or in patients with ongoing HCV infection risk.

Back
Next Restart simulation
Step
Result
Interpretation
1
anti-HCV test = ...
RNA / core antigen test = ...
waiting for input
1
anti-HCV test = negative
HCV RNA or core antigen test = positive

Current (active) HCV infection.

1
anti-HCV test = positive
HCV RNA or core antigen test = positive

Current (active) HCV infection.

1
anti-HCV test = positive
HCV RNA or core antigen test = negative

No indication of current (active) HCV infection.

1
anti-HCV test = negative
HCV RNA or core antigen test = negative

No current HCV infection.

End of test sequence