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

Updated: Jul 29, 2019
  • Author: Joel Schifter, MD; Chief Editor: Eric B Staros, MD  more...
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These tests detect antibodies to HCV (anti-HCV) and are used for screening and diagnosing HCV infection. Results are reported as anti-HCV positive or negative values. Three different assays are approved by the US Food and Drug Administration (FDA) for clinical use, Abbott HCV enzyme immunoassay (EIA) 2.0 (Abbott laboratories), ORTHO HCV version 3.0 enzyme-linked immunoassay (ELISA) (Ortho-Clinical Diagnostics) and VITROS Anti-HCV assay (Ortho-Clinical Diagnostics). These tests have very high sensitivity and specificity for HCV detection (sensitivity of greater than 99%, specificity of 99% in immunocompetent patients).

A negative test is sufficient to exclude a diagnosis of chronic HCV infection in immune-competent patients. Those on hemodialysis and patients with immune deficiencies may have false-negative results, whereas false-positives may occur in patients with autoimmune disorders. [1, 2]

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