Technology ID
TAB-2659
Real-time RT-PCR Assay For Detection and Quantification of Hepatitis D Virus Infection
E-Numbers
E-510-2013-0
E-510-2013-1
E-510-2013-2
Lead Inventor
Kodani, Maja (CDC)
Co-Inventors
Mixson-Hayden, Tonya (CDC)
Kamili, Saleem (CDC)
Applications
Diagnostics
Therapeutic Areas
Infectious Disease
Development Status
- Pre-clinical
- In vitro data available
Lead IC
CDC
ICs
CDC
CDC scientists have developed a one-step TaqMan quantitative/real-time reverse transcription-polymerase chain reaction (qRT-PCR) assay for detecting hepatitis D virus (HDV) RNA. Additionally, a quantifiable synthetic RNA control to determine viral load has been created.
HDV is an operatively defective virus that requires hepatitis B virus (HBV) surface antigen (HBsAg) for its assembly. Compared to individuals infected with HBV alone, individuals infected with both HDV and HBV viruses present with more severe hepatitis, progress to liver disease more quickly, and have a higher mortality rate. Currently, there are no regulated tests available for detection and quantification of HDV RNA. This assay directly addresses this unmet need and has been validated with clinical samples of HDV genotypes 1 and 3. It has the potential to detect all eight HDV genotypes.
HDV is an operatively defective virus that requires hepatitis B virus (HBV) surface antigen (HBsAg) for its assembly. Compared to individuals infected with HBV alone, individuals infected with both HDV and HBV viruses present with more severe hepatitis, progress to liver disease more quickly, and have a higher mortality rate. Currently, there are no regulated tests available for detection and quantification of HDV RNA. This assay directly addresses this unmet need and has been validated with clinical samples of HDV genotypes 1 and 3. It has the potential to detect all eight HDV genotypes.
Commercial Applications
- Development of a commercial nucleic acid assay for diagnosis of current hepatitis D virus (HDV) infection
- Public health and vaccination programs
- Testing of individuals infected with hepatitis B and/or liver disease
Competitive Advantages
- Rapid, accurate, inexpensive and stable
- Unique RNA transcript for this assay can be successfully used as a quantitative standard
- Current anti-HDV antibody assay identifies individuals exposed to HDV, but cannot identify current infection
- Easily adapted for inclusion in a hepatitis testing kit, especially when paired with a hepatitis B diagnostic
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