Abbott announced that the FDA has approved its RealTime HBV assay for measuring the amount of hepatitis B virus (HBV) in human plasma or serum from individuals chronically infected with HBV. The Abbott RealTime HBV assay, based on real-time polymerase chain reaction (PCR) technology, detects and measures all known HBV genotypes (A-H) by targeting an essential, highly conserved segment of the HBV genome. This automated HBV viral load test is capable of quantitating a broad range of virus levels in patient’s blood, ranging from very low levels of 10 IU/mL to very high levels of 1 billion IU/mL.

The Abbott RealTime HBV assay is intended to be used as an aid in the management of patients with chronic HBV infection undergoing antiviral therapy by measuring HBV DNA levels at baseline and during treatment to assess response to treatment.

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