A new dual-targeting real-time RT-PCR assay for hepatitis D virus RNA detection.

Abstract In this study, a real-time reverse transcription–polymerase chain reaction (real time RT-PCR) assay targeting 2 genetic segments was established to detect HDV RNA. Utilizing the World Health Organization International Standard for Hepatitis D Virus RNA, the lower limit of detection was 575 IU/mL, and the linearity of quantification ranged from 575,000 IU/mL to 575 IU/mL. 384 HBsAg-positive samples collected from China were tested by this method and HDV antibody detection. Eleven samples were positive for anti-HDV IgG which may persist after HDV resolution, 6 samples were HDV RNA positive, and 5 samples were positive for anti-HDV IgM. This assay showed more sensitivity than the detection of anti-HDV IgM. These data demonstrate that the real-time RT-PCR assay for HDV RNA could be implemented in the clinical detection of HDV infection in chronic HBV-infected patients in China. Highlights • No commercially rapid etiological test for HDV infection is available in China. • Dual-targeting real-time RT-PCR assay for HDV RNA was established. • The design of 2 targets could improve the sensitivity of the real time RT-PCR detection. • It was evaluated by WHO international standard and applied in clinical samples. [ABSTRACT FROM AUTHOR]