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Abbott Obtains CE Mark for Hepatitis B Rapid Diagnostic Test

Abbott has secured CE mark approval for Determine HBsAg 2, which is claimed to be the world's most sensitive rapid diagnostic test to detect hepatitis B surface antigen.

Developed to be used with serum, plasma or whole blood, the rapid lateral flow test allows to identify people with the virus and facilitates linkage to care in every healthcare setting.

Determine HBsAg 2 is said to offer rapid and accurate results of individual’s HBV status with an analytical sensitivity of 0.1 IU/mL.

Determine HBsAg 2 is an in-vitro, visually read and qualitative immunoassay, which holds capacity to detect HBV within 15 minutes.

Abbott is currently marketing Determine HBsAg 2 test in Europe, Africa, Asia Pacific and Latin America. The firm also submitted test’s data for WHO prequalification.

The World Health Organization (WHO) has set baseline targets to diagnose 30% of HBV-infected individuals by 2020 and 90% by 2030, as part of its efforts to reduce the current burden of disease.

Abbott infectious disease-emerging markets vice president Damian Halloran said: “To achieve the WHO targets, 107 million HBV-infected people need to be urgently diagnosed, especially in highly endemic regions in Africa and Asia.

“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.”

Separately, Abbott has entered into a non-exclusive partnership with Novo Nordisk to provide integrated digital solution to people with diabetes using insulin.

The partnership will facilitate to integrate insulin dose data from Novo Nordisk pre-filled and durable connected pens directly into the digital health tools compatible with the FreeStyle Libre system.

The integrated digital solution will allow healthcare professionals, caregivers and people with diabetes to view glucose and insulin data together to help them make more informed treatment decisions.

Novo Nordisk commercial innovation corporate vice president Anders Dyhr Toft said: “Together with partners like Abbott, our connected pens will give healthcare professionals a better understanding of a patient′s individual diabetes management and can help people with diabetes feel more confident in their treatment.”

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