How is hepatitis C (hep C) infection diagnosed?

Updated: Oct 07, 2019
  • Author: Vinod K Dhawan, MD, FACP, FRCPC, FIDSA; Chief Editor: BS Anand, MD  more...
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Hepatitis C virus (HCV) infection is diagnosed through the detection of antibodies to recombinant HCV polypeptides. However, antibody assays do not distinguish past from current HCV infection. For this reason, follow-up testing for HCV RNA is necessary to distinguish between ongoing or prior infection in persons with HCV antibodies.

Several generations of US Food and Drug Administration (FDA)-approved enzyme immunoassays (EIAs) to measure antibodies against NS4, core, NS3, and NS5 sequences are commercially available. [59] The third-generation assay is 97% sensitive. It can detect HCV antibody at an average of 8 weeks after the onset of infection. The recombinant immunoblot assay, previously used to confirm HCV infection, is not necessary owing to the improved sensitivity of the positive EIA tests with currently recommended higher cutoff values.

False-negative results for the presence of HCV antibody can occur in persons with compromised immune systems, such as those with human immunodeficiency virus (HIV) infection, renal failure, or HCV-associated essential mixed cryoglobulinemia. False-positive EIA results can also occur; the likelihood of a false-positive result is greater in persons without risk factors and in those without signs of liver disease, such as blood donors or healthcare workers.

In 2010, the FDA approved the OraQuick HCV Rapid Antibody Test, which can be used for persons at risk for hepatitis or for those with signs or symptoms of hepatitis. The test strip can be used with a sample collected from a fingerstick or venipuncture whole blood. [60]

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