New diagnostic device detects hepatitis B in 15 minutes

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The highly sensitive Determine HBsAg rapid test will be rolled out to African countries this year.
The highly sensitive Determine HBsAg rapid test will be rolled out to African countries this year.

Global healthcare firm Abbott has developed a device that conducts a rapid diagnostic test for the detection of hepatitis B.

The newly introduced device, Determine HBsAg 2, tests the patient's serum, plasma or whole blood, where it identifies hepatitis B surface antigen, a surface particle from the hepatitis B virus that is found circulating in the blood serum of infected individuals.

The highly sensitive rapid test will be rolled out globally, including in African countries, to enable identification of those with the virus and facilitate linkage to care in every healthcare setting.

Hepatitis B is a 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.

"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, anti-viral medication," says Patrick Kennedy, MD, 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."

If a patient has been recently infected with hepatitis B, it may take up to nine weeks before the virus can be detected in their blood.

The Determine HBsAg 2, which is used at a healthcare facility, is dipped into the serum, plasma or whole blood sample and is able to detect the B surface antigen in 15 minutes, while the patient is still present.

This allows for prompt treatment decisions by the healthcare practitioner, notes Abbott.

Hepatitis screening methods usually involve three stages of testing for blood samples, known as the serologic panel. This set of tests can accurately diagnose current and past hepatitis B.

Patents using the Determine HBsAg device would still be required to go through additional testing.

An estimated 257 million people worldwide were living with chronic HBV infection in 2018, according to the World Health Organisation (WHO). While the global burden of this disease is significant, the rate of diagnosis is extremely low, at approximately 9% of all HBV-infected persons.

In a global effort to reduce the current burden of disease, the WHO has set targets to diagnose 30% of HBV-infected individuals by 2020 and 90% by 2030.

"To achieve the WHO targets, 107 million HBV-infected people need to be urgently diagnosed, especially in highly endemic regions in Africa and Asia," says Damian Halloran, VP of infectious disease, emerging markets at 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."

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