Technology Bundle ID: TAB-2659

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

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Licensing Contact:
Primary Inventors: 
Maja Kodani (CDC)
Co-Inventors: 
Saleem Kamili (CDC), Tonya Mixson-Hayden (CDC)
Therapeutic Area: 
Infectious Disease
Application: 
Diagnostics
Development Status: 
  • Pre-clinical
  • In vitro data available
Institute or Center: 
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.

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
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

Patents

PCT Application PCT/US2014/029049
Filed on 2014-03-14
US Application 14/777,353
Filed on 2015-09-15
US Application 61/792,293
Filed on 2013-03-15
US Application 61/938,220
Filed on 2014-02-11

Publications

Kodani M, et al.
PMID 23896020

Updated

Oct 18, 2013

Data Source: 
tts