What are the molecular assays for diagnosing and managing hepatitis C (HCV) infection?

Updated: Jul 14, 2021
  • Author: Joel Schifter, MD; Chief Editor: Eric B Staros, MD  more...
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These tests are approved by the US Food and Drug Administration (FDA) for the detection of HCV RNA; they can be qualitative or quantitative. Qualitative tests only detect the presence of HCV RNA (specificity, approximately 98%) whereas the quantitative assays detect the viral load in IU/mL (specificity, approximately 98-99%) and provide adequate information that guides clinicians to manage and monitor treatment outcome. [1, 3]

Both types of assays in association with the clinical presentation (jaundice, ALT elevation) have been used to adequate identify acute or chronic HCV infections. After an acute HCV infection, HCV RNA could be detectable in serum within 2 weeks following exposure. On the other hand, anti-HCV could take about 8-12 weeks before results are positive. Both test results are positive in case of acute or chronic infection.

However, anti-HCV positivity with nondetectable HCV RNA could be seen in cases of acute infection during a period of viral clearance and false positives may result; this may also occur after recovery from infection or following spontaneous resolution of HCV infection. On the other hand, HCV RNA results can be positive with negative anti-HCV findings in cases of early stages of acute infection, false positive results, or chronic infection in an immunosuppressed individual. [1]

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