CE Mark for Determine HBsAg 2 test for the detection of hepatitis B surface antigen.-Abbott
Abbott announced it has received CE Mark for the world's most sensitive rapid diagnostic test for the detection of hepatitis B surface antigen, the Determine HBsAg 2 test for use with serum, plasma or whole blood. This highly sensitive, easy-to-use, rapid lateral flow test enables identification of those with the virus and facilitates linkage to care in every healthcare setting.
In a global effort to reduce the current burden of disease, the World Health Organization (WHO) has set baseline targets to diagnose 30 percent of HBV-infected individuals by 2020 and 90 percent by 2030.5 In order to reach these targets, rapid testing is imperative. Testing and diagnosis of HBV is the gateway for access to both prevention and treatment services and is a critical component of an effective response to the hepatitis epidemic. Early identification of people with chronic HBV allows them to receive the necessary care and treatment to prevent or delay progression of liver disease. Testing also provides an opportunity for interventions that reduce transmission, through counselling on risk behaviors and provision of prevention products, such as sterile needles, and on vaccination. High sensitivity tests are important for certain populations, such as pregnant women, to reduce mother-to-child transmission, and for HIV-positive individuals, in which it may be difficult to detect HBV.1 Highly sensitivity tests such as the Determine HBsAg 2 allow people in these populations to be diagnosed quickly and accurately and linked to appropriate care.
"Because HBV is severely underdiagnosed, it is crucial to regularly screen people 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..
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