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

Description:

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.