HBV test - Abbott RealTime HBV Assay - P080026

This medical device was FDA approved on August 13, 2010 and is a lab kit.  It works by measuring blood levels of hepatitis B viral DNA.  The test is used (along with other lab tests and clinical information) to measure an individual (infected by the HBV - hepatitis B virus) prior to and during treatment and provides a quantitative analysis of how the patient is responding to treatment.

It is indicated to treat HBV infected adults.  There are a number of contraindications including – not to be used to screen for hepatitis B virus, not to screen blood (or blood products) for hepatitis B virus or to predict the outcome of treatment.  It is to be ordered by a physician only.