| Test Name and Number | Recommended Use | Limitations | Follow Up |
|---|
| Hepatitis C Virus Antibody 0020099 Method: Chemiluminescent Immunoassay
|
Screen individuals at risk for HCV infection
| |
For high positive results, collect a new specimen and order quantitative hepatitis C viral load.
Order genotyping once diagnosis is established.
|
| Hepatitis C Virus Antibody (RIBA), Supplemental 0020104 Method: Recombinant Immunoblot Assay
|
Use for patients with low-positive anti-HCV screening results
| HCV RIBA is excessively ordered Do not use to confirm high positive anti-HCV screening results
|
|
| Hepatitis C Virus Antibody with Reflex to Supplemental RIBA 0020700 Method: Chemiluminescent Assay/Recombinant Immunoblot Assay
|
Screen individuals at risk for HCV infection; includes automatic RIBA for low-positive screens
| |
|
| Hepatitis C Virus RNA Quantitative, Real-Time PCR 0098268 Method: Real-Time Polymerase Chain Reaction
|
Diagnose HCV infection in anti-HCV positive patients
Provide a baseline for monitoring treatment efficacy
Determine length of treatment
Guide therapy by early identification of patients who are unlikely to have a sustained therapeutic response (Failure to lower HCV quantitative levels during the first 12 weeks of therapy strongly predicts that a sustained therapeutic response will not be achieved)
Assess mother-to-child transmission of HCV in newborns of HCV-positive mothers
| A negative result does not rule out the presence of PCR inhibitors in the patient sample nor HCV RNA concentrations below the level of detection by the assay (75 IU/mL). False-positive results may occur. |
For lower levels of HCV viremia, order HCV RNA qualitative testing
|
| Hepatitis C Virus RNA Qualitative PCR 0098264 Method: Polymerase Chain Reaction
|
Most physicians prefer the quantitative test (0098268) for monitoring early treatment
Monitor ongoing viral response to therapy when quantitative test is negative
Assess end of treatment response
Assess mother-to-child transmission of HCV in newborns of HCV-positive mothers
| A negative result does not rule out the presence of PCR inhibitors in the patient sample nor HCV RNA concentrations below the level of detection by the assay (50 IU/mL). False-positive results may occur. | |
| Hepatitis C Virus RNA Quantitative bDNA 0098757 Method: Branched Chain DNA
|
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 a sustained therapeutic response (Failure to lower HCV quantitative levels during the first 12 weeks of therapy strongly predicts that a sustained therapeutic response will not be achieved)
| Low (< 6000 IU/mL) false-positive results can occur A negative result does not rule out HCV RNA concentrations below the level of detection by the assay (615 HCV IU/mL) Caution should be taken in the interpretation of any single viral load determination |
For lower levels of HCV viremia, order HCV RNA qualitative PCR
|
| Hepatitis C Virus Genotyping by PCR & Sequencing 0055593 Method: Polymerase Chain Reaction/Nucleic Acid Sequencing
|
Identify genotypes to determine therapeutic regimens
Identify source of infection, particularly for geographically distinct subtypes
| Very low viral loads (< 1,000 IU/mL) may not amplify by PCR and, therefore, cannot be typed |
|
| Hepatitis C Virus RNA Quantitative by Real-Time PCR with Reflex to Genotype 0055604 Method: Real-Time Polymerase Chain Reaction/Sequencing
|
Diagnose HCV infection in anti-HCV positive patients
Provide baseline viral load for monitoring treatment efficacy
Determine length of treatment
Determine genotype if infected
| |
|
| Hepatitis C Virus RNA Quantitative bDNA with Reflex to Genotype 0051306 Method: Branched Chain DNA/Sequencing
|
Diagnose HCV infection in anti-HCV positive patients
Provide a baseline viral load for monitoring treatment efficacy
Determine length of treatment
Determine genotype if infected
| |
|
| Hepatitis C Virus RNA Quantitative with Reflex to Qualitative PCR 0056114 Method: Polymerase Chain Reaction
|
Monitor on-going treatment
Reflexes to more sensitive test, as needed
| |
|
| Hepatitis C Virus RNA Quantitative bDNA with Reflex to Qualitative PCR 0051307 Method: Branched Chain DNA/Polymerase Chain Reaction
|
Monitor on-going treatment
Reflexes to more sensitive test, as needed
| |
|
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The Physician's Guide to Laboratory Test Selection and Interpretation
