Test Detects Hepatitis B Mutants

An ultra-sensitive test for the detection of hepatitis B virus (HBV) mutants has been developed, providing a new diagnostic tool that will help doctors identify various medical conditions.

For example, the test could help doctors identify infant breakthrough infection from a pregnant HBV carrier patient or the post-transplantation relapse of liver transplant patients. More than 400 million people are chronic carriers of HBV, according to the World Health Organization (WHO, Geneva, Switzerland). Chronic infections can lead to hepatacellular carcinoma and liver failure. An assay that can detect very low levels of virus and mutant strains could be an important tool in the development of new therapies and the management of hepatitis patients.

The test was developed by the Bloodborne Pathogens and Hepatitis Lab of Health Canada (Ottawa), based on the Origen technology of Igen International (Gaithersburg, MD, USA). The test utilized gLCT, a DNA amplification method. The new assay's sensitivity was demonstrated by its ability to detect 10 copies of mutant DNA and the detection of low levels of mutant DNA in the presence of excess wild-type DNA.

"This new application further solidifies the applicability of Origen technology in the drug discovery and clinical markets,” stated Samuel J. Wohlstadter, chairman and CEO of Igen. Origen technology has been previously used in the direct detection of nucleic acids using other amplification methods such as polymerase chain reaction (PCR) and nucleic acid sequence based amplification (NASBA).




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Health Canada
Igen International