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HCV Testing

The Bloodborne Viruses Laboratory performs HCV antibody and RNA testing to identify HCV infection, quantify HCV viral load, and determine genotype/subtype. These tests are only performed under certain circumstances, such as HCV public health investigations, difficult to characterize specimens, or to confirm HCV infection.  Our lab follows the updated CDC recommendations. Contact the laboratory to request approval to submit specimens for HCV testing.

After receiving approval to submit specimens, follow the collection and shipping guidelines for the test requested, complete the DOH-49 test requisition form in full and choose the appropriate test from the HCV testing menu:

  • HCV Antibody testing with reflex to HCV RNA testing
  • HCV RNA testing only
  • HCV viral load
  • HCV genotyping

HCV Tests Available

HCV Antibody test: The Abbott ARCHITECT Anti-HCV assay is used for the detection of antibodies to the hepatitis C virus (HCV). The ARCHITECT Anti-HCV assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to hepatitis C virus (anti-HCV) in human adult serum and plasma.  A reactive result may indicate past exposure, current infection or a false positive test.  An HCV RNA test must be performed to determine a current active infection. 

HCV RNA tests for detection and/or viral load: A laboratory-developed Real-Time PCR assay is used to detect and quantify HCV RNA isolated from human plasma. The assay detects a conserved region of the HCV 5’ untranslated region. Assay steps include viral RNA extraction, reverse transcription, and detection by real-time PCR. Results may be reported as qualitative or quantitative depending on the test requested. This assay has been approved for clinical use by the Clinical Laboratory Evaluation Program.  It has a limit of detection of 5 IU/ml and lower limit of quantification of 26 IU/ml. 

HCV Genotyping: The HCV genotyping assay is used to determine the genotype and subtype of HCV isolated from patient plasma by direct sequencing of the 5’ untranslated region and the NS5b region of the HCV genome.  This assay involves viral RNA extraction, reverse transcription, PCR amplification and sequencing. Genotype and subtype are determined by comparing the resulting sequences to HCV 5’UTR and NS5b sequences from reference strains.  Sequence from the NS5b region provides additional information that may be used for epidemiologic investigations and infection control purposes.