Abbott's new Determine™ HBsAg2 is a life-changing tool for detecting hepatitis B.

Filling a Big Need Among Smallest of Us

Feb 19 2019

Imagine having the most common serious liver infection in the world and not knowing it. That's the reality for most people infected with the hepatitis B virus (HBV).

Transmitted through blood and bodily fluids, HBV is preventable and treatable. But its symptoms are often silent, so many people don't know they're infected. Left untreated, though, HBV can lead to cirrhosis (scarring of the liver), liver cancer, or liver failure.

According to the World Health Organization (WHO), an estimated 257 million people are living with the disease – a number significantly higher than those living with HIV. To reduce the current burden of HBV, the WHO has set forth goals to diagnose 30 percent of infected individuals worldwide by 2020 and 90 percent by 2030.1 Rapid testing is critical to achieving these goals – and this is where Abbott can help.

Rapid diagnosis is critical to early intervention

One of the main reasons for the global burden of hepatitis is the extremely low rate of diagnosis. Only 9 percent of HBV-infected people are diagnosed, out of which only a fraction receives treatment.1 At Abbott, we recognize that rapid diagnostics are critical to eliminating HBV, which is why we continue to develop life-changing technologies that can be used in a variety of settings to detect infections earlier.

Our latest solution, the Determine™ HBsAg 2, is the world's most sensitive rapid diagnostic test for the detection of hepatitis B surface antigen (HBsAg) for use with serum, plasma or whole blood. In just 15 minutes, this highly sensitive, easy-to-use rapid test provides accurate diagnosis and can be the first step in treating someone with HBV.

The Determine HBsAg 2 test is especially critical in certain populations, including pregnant women, to reduce mother-to-child transmission of HBV, and HIV-positive individuals, in whom it may be difficult to detect the virus.

The new test is also part Abbott’s broader portfolio of life-changing technologies for hepatitis, which extends testing from the core laboratory to the point of care for people living in remote and underserved communities.

"Because HBV is a severely underdiagnosed disease, it is crucial to regularly screen populations and efficiently link those who test positive to specialist care and where indicated, antiviral medication," said Patrick Kennedy, M.D., Reader and Consultant Hepatologist at Barts and The London School of Medicine and Dentistry. "Early diagnosis may support timely viral suppression, which reduces the risk for HBV-related complications. The highly portable Determine HBsAg 2 test will help increase access to accurate testing for people living in remote areas who are at-risk for HBV."

Early identification of people with chronic HBV allows them to receive necessary care. Testing also provides an opportunity to link people with interventions that reduce transmission, through counselling on risk behaviors and provision of prevention products such as sterile needles and vaccination.

The Determine HBsAg 2 test is now commercially available in Europe, Africa, Asia Pacific and Latin America. It has already received CE Mark and data has been submitted for WHO prequalification.


1. WHO Global Hepatitis Report 2017



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