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.
| Test Name and Number | Recommended Use | Limitations | Follow Up |
|---|---|---|---|
| Hepatitis Panel, Acute with Reflex to HBsAg Confirmation 0020457 Method: Qualitative Chemiluminescent Immunoassay |
Order to evaluate viral etiology in patients with acute hepatitis Not recommended for screening asymptomatic patients Panel includes HAV IgM, HBV core antibody IgM, HBV surface antigen with reflex to confirmation, HCV antibody |
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| Hepatitis B Virus Surface Antigen with Reflex to Confirmation 0020089 Method: Qualitative Chemiluminescent Immunoassay |
Initial testing for suspected chronic HBV infection |
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| Hepatitis C Virus Antibody by CIA 2002483 Method: Qualitative Chemiluminescent Immunoassay |
Screen individuals at risk for HCV infection |
For positive results, order HCV RNA PCR (quantitative or qualitative) Order genotyping once diagnosis is established |
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| Hepatitis C Virus RNA Quantitative, Real-Time PCR 0098268 Method: Quantitative Real-Time Polymerase Chain Reaction |
Preferred test to confirm active HCV infection following HCV high-positive screen Establish baseline viral load prior to initiation of therapy Monitor therapy Evaluate prognosis and disease progression Assess transmission of HCV in newborns from HCV-positive mothers |
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" | |
| Hepatitis C Virus RNA Quantitative Real-Time PCR with Reflex to Genotype 2002685 Method: Quantitative Real-Time Polymerase Chain Reaction/Sequencing |
Preferred reflex test to confirm active HCV infection following HCV high-positive screen |
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| Hepatitis C Virus RNA Qualitative PCR 0098264 Method: Qualitative Polymerase Chain Reaction |
Quantitative test generally preferred Assess transmission of HCV in newborns from HCV-positive mothers |
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 | |
| Hepatitis C Virus RNA Quantitative bDNA 0051811 Method: Quantitative Branched Chain DNA |
Not recommended to confirm active HCV infection; quantitative PCR generally preferred If used, provide a baseline viral load for monitoring treatment efficacy |
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 |
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| Hepatitis C Virus Genotyping 0055593 Method: Polymerase Chain Reaction/Sequencing |
Order before initiating HCV therapy to aid in determining therapy of choice, likelihood of response, and probable therapeutic duration Do not order prior to molecular confirmation of positive HCV screen |
Test may be unsuccessful if HCV RNA viral load is <log 2.8 or 600 IU/mL |
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| Hepatitis C Virus High-Resolution Genotyping 2006898 Method: Polymerase Chain Reaction/Sequencing |
May be used for prognosis and treatment selection requiring a higher level of subtype resolution such as non 6a/b versus type 1 and type 1a versus 1b Do not order prior to molecular confirmation of positive HCV screen |
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| Interleukin 28 B (IL28B)-Associated Variants, 2 SNPs 2004680 Method: Qualitative Polymerase Chain Reaction/Qualitative Fluorescence Monitoring |
Detect genetic variants associated with interleukin 28 B (IL28B) that may aid in predicting probability of therapeutic response (IL28B) |
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 not well established |
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| Inosine Triphosphatase (ITPA) and Interleukin 28 B (IL28B)-Associated Variants, 4 SNPs 2006344 Method: Polymerase Chain Reaction/Single Nucleotide Extensions |
Detect genetic variants associated with interleukin 28 B (IL28B) and inosine triphosphatase (ITPA) that may aid in predicting probability of therapeutic response (IL28B) and dose planning (ITPA) |