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Abbott Receives CE Mark for Hepatitis B Point-of-Care Test

NEW YORK (360Dx) – Abbott said today it has received CE marking for its Determine HBsAg 2 rapid diagnostic test used to detect hepatitis B surface antigen.

The firm said that the test provides results of HBV status in 15 minutes with an analytical sensitivity of 0.1 IU/mL, enabling clinicians to make prompt treatment decisions .

Abbott said that its rapid lateral flow immunoassay is highly sensitive, easy-to-use, and facilitates "linkage to care in every healthcare setting."

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 counseling on vaccination and risk behaviors and provision of prevention products, such as sterile needles, Abbott said.

Hepatitis B, a serious liver infection caused by the hepatitis B virus, can become chronic and lead to liver failure, liver cancer, or cirrhosis, a condition that permanently scars the liver.

According to the Centers for Disease Control and Prevention, about 1.2 million people in the US and 350 million people worldwide have hepatitis B. While the global burden of this disease is significant, only approximately 9 percent of all HBV-infected persons are diagnosed, Abbott said.

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, the firm said.

The Determine HBsAg 2 is commercially available in Europe, Africa, Asia Pacific, and Latin America, and Abbott said it has submitted data for World Health Organization prequalification.