Laboratory Testing for Hepatitis B

Molecular Testing

June 2008

For molecular testing, Hepatitis B treatment requires baseline viral load monitoring prior to starting treatment. However, the current molecular tests are not indicated or helpful for diagnostic purposes. Diagnosis is still based on serologic findings and presence of Hepatitis B surface antigens will provide a diagnosis for chronic or acute Hepatitis B.

Currently, there are various test methods, commercially as well as laboratory-developed methods for determining Hepatitis B DNA in serum and plasma. The commercially-available COBAS Amplicor HBV Monitor from Roche Diagnostics is a PCR-based assay with a range of 58-38,462 IU/mL.

The Digene Hybrid Capture II HBV DNA Test comes in two forms, standard and ultra-sensitive. The range of results is different for these two. The Digene Hybrid Capture is now part of QIAGEN Incorporated.

The Versant HBV DNA 3.0 is a branch DNA signal-amplification method from Siemens HC Diag. It has a range from 357-17.8 million IU/mL.

Finally, the TaqMan HBV assay is a real-time PCR method available in the United States as an analyte specific reagent, has the widest result range of all these tests with a lower limit of quantitative as low as 10 IU/mL.

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Jump to section:

• Introduction
• Patient Case
• Patient Case
• Acute HBV Infection with Recovery
• Progression to Chronic HBV Infection
• Serologic Markers
• Serologic Methods
• Diagnosis
• Anti-HBs - Qualitative vs Quantitative
• Anti-HBs - Qualitative vs Quantitative
• Molecular Testing
• HBV DNA Quantification Assays
• Patient Case
• Chronic Hepatitis B Therapeutic Options
• Patient Case
• Virologic Breakthrough During Rx for CHB
• HBV Genotyping and Drug Resistance Tests
• HBV Resistance Mutations
• Patient Case
• Summary
• Questions?
• Disclosure