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Hepatitis C is a virally mediated disease of the liver with a propensity to cause chronic infection leading to cirrhosis and an increased risk of hepatocellular carcinoma.
Tests generally appear in the order most useful for common clinical situations
| Test name: Hepatitis Panel, Acute with Reflex to HBsAg Confirmation |
| ARUP #: 0020457 |
| Methodology: Qualitative Chemiluminescent Immunoassay/Qualitative Enzyme Immunoassay |
| Use: Order when patient has had clinical acute hepatitis of unknown origin for less than 6 months Panel includes HAV IgM, HBV core antibody IgM, HBV surface antigen, HCV antibody Positive HAV IgM shows current or recent infection with 98% sensitivity and specificity |
| Test name: Hepatitis A Virus Antibody, IgM |
| ARUP #: 0020093 |
| Methodology: Qualitative Chemiluminescent Immunoassay |
| Use: Rule out acute HAV |
| Test name: Hepatitis B Virus Core Antibody, IgM |
| ARUP #: 0020092 |
| Methodology: Qualitative Chemiluminescent Immunoassay |
| Use: Rule out HBV |
| Test name: Hepatitis B Virus Surface Antibody |
| ARUP #: 0020090 |
| Methodology: Quantitative Chemiluminescent Immunoassay |
| Use: Determine immunity to HBV |
| Test name: Hepatitis C Virus Antibody by CIA |
| ARUP #: 2002483 |
| Methodology: Qualitative Chemiluminescent Immunoassay |
| Use: Screen individuals at risk for HCV infection |
| Follow-up: For positive results, order HCV RNA PCR (quantitative or qualitative) Order genotyping once diagnosis is established |
| Test name: Hepatitis C Virus RNA Quantitative, Real-Time PCR |
| ARUP #: 0098268 |
| Methodology: Quantitative Real-Time Polymerase Chain Reaction |
| Use: Diagnose HCV infection in anti-HCV positive patients Provide baseline for monitoring treatment efficacy Determine length of treatment Guide therapy by early identification of patients unlikely to have sustained therapeutic response (failure to lower HCV quantitative levels during the first 12 weeks of therapy strongly predicts a sustained therapeutic response will not be achieved) Assess transmission of HCV in newborns from HCV-positive mothers |
| Limitations: Quantification limit for this assay is 1.6 log IU/mL (43 IU/mL) If the assay DID NOT DETECT the virus, the result will be reported as “<1.6 log IU/mL (<43 IU/mL)”; if the assay DETECTED the presence of the virus but was not able to accurately quantify the number of copies, the test result will be reported as “Not Quantified" False positive may occur |
| Test name: Hepatitis C Virus RNA Qualitative PCR |
| ARUP #: 0098264 |
| Methodology: Qualitative Polymerase Chain Reaction |
| Use: Quantitative test generally preferred Monitor ongoing viral response to therapy when quantitative test is negative Assess transmission of HCV in newborns from HCV-positive mothers |
| Limitations: Negative result does not rule out the presence of PCR inhibitors in the patient sample or the presence of HCV RNA concentrations below the level of detection by the assay False positives may occur |
| Test name: Hepatitis C Virus RNA Quantitative bDNA |
| ARUP #: 0051811 |
| Methodology: Quantitative Branched Chain DNA |
| Use: Diagnose HCV infection in anti-HCV positive patients Provide a baseline viral load for monitoring treatment efficacy Determine length of treatment Guide therapy by early identification of patients who are unlikely to have sustained therapeutic response (failure to lower HCV quantitative levels during the first 12 weeks of therapy strongly predicts that sustained therapeutic response will not be achieved) |
| Limitations: Negative result does not rule out the presence of PCR inhibitors in the patient sample or the presence of HCV RNA concentrations below the level of detection by the assay Low-positive values may occasionally be seen in specimens from patients who are not infected |
| Test name: Hepatitis C Virus Genotyping |
| ARUP #: 0055593 |
| Methodology: Polymerase Chain Reaction/Nucleic Acid Sequencing |
| Use: Identify genotypes to determine therapeutic regimens |
| Limitations: Test may be unsuccessful if HCV RNA viral load is <log 2.8 or 600 IU/mL |
| Test name: Interleukin 28 B (IL28B)-Associated Variants, 2 SNPs |
| ARUP #: 2004680 |
| Methodology: Qualitative Polymerase Chain Reaction/Qualitative Fluorescence Monitoring |
| Use: Identify therapeutic response in genotype 1 patients |
| Limitations: SNPs other than those targeted will not be detected For HCV genotypes other than type 1, the usefulness of these SNPs for predicting response to therapy is unknown |
| Test name: Hepatitis C Virus RNA Quantitative bDNA with Reflex to Hepatitis C Virus RNA Quantitative, Real-Time PCR |
| ARUP #: 2002682 |
| Methodology: Quantitative Branched Chain DNA/Polymerase Chain Reaction |
| Comments: Use for diagnostic purposes |
| Test name: Hepatitis C Virus RNA Quantitative bDNA with Reflex to Genotype |
| ARUP #: 2002681 |
| Methodology: Quantitative Branched Chain DNA/Nucleic Acid Sequencing |
| Comments: Diagnose HCV infection in anti-HCV positive patients and determine genotype Provide baseline viral load for monitoring treatment efficacy Determine length of treatment |
| Test name: Hepatitis C Virus RNA Quantitative Real-Time PCR with Reflex to Genotype |
| ARUP #: 2002685 |
| Methodology: Quantitative Real-Time Polymerase Chain Reaction/Nucleic Acid Sequencing |
| Comments: Quantification limit for this assay is 1.6 log IU/mL (43 IU/mL) If the assay DID NOT DETECT the virus, the test result will be reported as “<1.6 log IU/mL (<43 IU/mL)”; if the assay DETECTED the presence of the virus but was not able to accurately quantify the number of copies the test result will be reported as “Not Quantified” Diagnose HCV infection in anti-HCV positive patients and determine genotype Provide baseline viral load for monitoring treatment efficacy and determine length of treatment |
| Test name: FibroSURE |
| ARUP #: 2004745 |
| Methodology: Semi-Quantitative Immunologic/Colorimetry/Kinetic/Nephelometry |
| Comments: Provide assessment of liver status following diagnosis of HCV as well as baseline determination of liver status before initiating HCV therapy Also use for post-treatment assessment of liver status six months after completion of therapy and noninvasive assessment of liver status in patients who are at increased risk of complications from a liver biopsy |