Laboratory Testing for Hepatitis C

Hepatitis C: Molecular Tests

April 2008

Now commercially, molecular assays for laboratory testing of Hepatitis C come in qualitative as well as quantitative tests. Keep in mind that HCV RNA is the first viral marker that is detectable in the infected individual, usually by 2 weeks after infection.

These qualitative tests are useful for confirming the presence of acute or chronic Hepatitis C. However it is not useful for distinguishing between these two states of Hepatitis C. It is helpful for distinguishing chronic from past Hepatitis C infection, because in the latter, HCV RNA should not be present. Finally, it is useful to determine sustained virologic response which is defined as absence of Hepatitis C RNA to antiviral treatment.

The assays differ commercially in the limit of detection. Currently there are two FDA-approved assays in the United States: the COBAS AMPLICOR HCV Test Version 2 from Roche Diagnostics utilizes the RT-PCR method and it has a lower limit of detection at 50 IU/mL whereas the transcription mediated amplification method from Siemens Healthcare Diagnostics known as the VERSANT HCV RNA Qualitative Test, which has a lower limit of detection at 10 IU/mL.

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• Introduction
• Patient Case
• Hepatitis C: Diagnostic Approach
• Acute Hepatitis C with Recovery
• Acute Hepatitis C with Progression to Chronic Infection
• Hepatitis C: Serologic Assays
• HCV Antigens Used in EIAs and CIAs for Detecting HCV Total Antibodies
• Patient Case
• Laboratory Algorithm
• Comparison of PCR, TMA, and bDNA
• Hepatitis C: Molecular Assays
• Hepatitis C: Molecular Tests
• Interpretation of Laboratory Test Results for HCV Infection
• Patient Case
• Hepatitis C: Genotyping Assays
• Patient Case
• Questions?