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Health Canada licenses Qiagen’s hepatitis B test

Qiagen has announced that its newly released hepatitis B virus assay kit, known as artus HBV LC PCR Kit, is in compliance with Health Canada's medical device requirements.

The kit, which monitors the viral load of infected patients, is now available to doctors in Canada to help them determine the success of a treatment.

The ready-to-use molecular diagnostic detection kit for the quantitation of hepatitis B viral (HBV) DNA from plasma helps to monitor on-going drug therapy treatments for those people chronically infected with hepatitis B. The kit utilizes the polymerase chain reaction amplification technology and is configured for the widely available LightCycler Instrument.

The kit provides all necessary reagents optimized for reliable HBV DNA detection and quantitation, including of the HBV genotypes A to G. This spectrum of genotypes is representative of strains of the virus which can be found globally, ensuring highest sensitivity in monitoring of treatments, the company said.