Real-time RT-PCR Assay For Detection and Quantification of Hepatitis D Virus Infection


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.

Potential Commercial Applications: Competitive Advantages:
  • 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
 
  • 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


Development Stage:
  • Pre-clinical
  • In vitro data available


Inventors:

Maja Kodani (CDC)  ➽ more inventions...

Tonya Mixson-Hayden (CDC)  ➽ more inventions...

Saleem Kamili (CDC)  ➽ more inventions...


Intellectual Property:
US Application No. 14/777,353
US Application No. 61/792,293
US Application No. 61/938,220
PCT Application No. PCT/US2014/029049

Publications:
Kodani M, et al. PMID 23896020

Licensing Contact:
Jeremiah Mitzelfelt,
Email: jeremiah.mitzelfelt@nih.gov
Phone: 301-443-8518

OTT Reference No: E-510-2013/0
Updated: May 22, 2014