Abbott announced today 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.1,2,3 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.
Hepatitis B is a serious liver infection caused by the hepatitis B virus (HBV). For some people, hepatitis B infection becomes chronic and can lead to liver failure, liver cancer or cirrhosis of the liver, a condition that permanently scars the liver.4
An estimated 257 million people worldwide were living with chronic HBV infection. While the global burden of this disease is significant, the rate of diagnosis is extremely low, at approximately 9 percent of all HBV-infected persons. Furthermore, among those diagnosed with HBV, only 8 percent actually received treatment.5
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.
“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.”
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.
“To achieve the WHO targets, 107 million HBV-infected people need to be urgently diagnosed, especially in highly endemic regions in Africa and Asia,” said Damian Halloran, vice president, Infectious Disease-Emerging Markets, Abbott. “The unparalleled sensitivity, portability and ease-of-use of the Determine HBsAg 2 provides life-changing technology that can dramatically scale up testing services so more infected people can know their status and get treatment earlier.”