GENETICALLY ENGINEERED CLONE OF HEPATITIS E VIRUS (HEV) GENOME WHICH IS INFECTIOUS, ITS PRODUCTION AND USES

摘要

The present invention relates to a unique genetically engineered nucleic acid clone of hepatitis E virus (HEV) which comprises the complete structural (ORF2 and ORF3) and non-stuctural (ORF1) genes, viz. the complete coding sequence, of HEV, flanked by 5` and 3`non-coding regions along with a 3`polyadenylated tail to the 3` non-coding region, said clone being capable of infecting cultured liver cells and replicating, transcribing and assembling HEV therein. The invention also incorporates within its scope a process for synthesising such clone and the expression therefrom of viral proteins adapted for use in the detection of the presence of antibodies to HEV in biological samples. Other uses to which the clone and the expressed viral proteins can be put include a diagnostic test kit for the presence of HEV infection comprising said viral proteins, and HEV vaccine comprising non-infectious HEV particles produced from a mutation of said nucleic acid clone of hepatitis E virus and an assay system for rapid anti-HEV drug testing.