Qiagen hepatitis B test to be licensed by Health Canada

Qiagen has announced that its hepatitis B virus (HBV) assay kit complies with Health Canada’s medical device requirements.

Now available to doctors in Canada to help them determine the success of a treatment, the artus HBV LC PCR Kit monitors the viral load of HBV-infected patients.

Ready-to-use, the molecular diagnostic detection kit for the quantitation of hepatitis B viral DNA from plasma is intended to help monitor ongoing drug therapy treatments for people chronically infected with the disease.

"The artus HBV kit will play an important role in assisting healthcare workers in monitoring hepatitis B patients’ viral load," confirmed Doug White, senior vice-president of sales and marketing for the US.

"This is extremely important for the implementation and administration of successful therapy," he added.

Utilising polymerase chain reaction (PCR) amplification technology, the kit is configured for the widely available LightCycler instrument.

Qiagen sells a number of products approved or cleared for in-vitro diagnostic use in the US, including the only FDA-approved test for the human Papillomavirus, which plays a key role in cervical cancer screening and prevention.