09:29pm Sunday 13 October 2019

EU gives green light for while-you-wait Hepatitis B test

Hepatitis B virus (HBV) is highly infectious – 100 times more infectious than HIV – and is endemic in many parts of the world. In the UK, one in 1000 people is infected and in China and Africa, as many as one in six people carries the virus.

The virus is spread through contact, including sexual contact, with infected blood or other body fluids. Although the infection rarely kills, it can cause serious health problems and places a tremendous strain on healthcare resources.

The new Hepatitis B Rapid Test, developed with a Strategic Translation Award from the Wellcome Trust, uses a dipstick technology to deliver an accurate diagnosis on-site within half an hour and can be used with minimal training. Current methods of diagnosis require sending patient samples away to laboratories for analysis by skilled technicians using expensive machinery, taking days or even weeks to obtain the results.

Professor Baruch S Blumberg, who was awarded the Nobel Prize in Physiology Medicine for the discovery of the Hepatitis B virus and the invention of the HBV vaccine, said: “Approval of the new Hepatitis B Rapid Test is positive news for the estimated 400 million HBV carriers worldwide. Studies have shown that anti-viral treatment can significantly decrease the risk of death from diseases linked to HBV infection, but most of the HBV carriers and patients in the world remain unidentified.”


“Being able to identify carriers, initiate immediate treatment of appropriate candidates, and vaccinate family members and close contacts, has the potential to greatly accelerate the programme to control HBV infection and spread.”


“HBV infection and the diseases related to it are solvable problems. The Hepatitis B Rapid Test developed by Diagnostics for the Real World can make a significant contribution to the solution.”

Dr Helen Lee from Diagnostics for the Real World, who led the development of the test, said: “Our test is simple, quick, inexpensive and can survive very hot conditions for many months – all vital factors when you are working in poorer parts of the world.”

The new test is expected to make a vital impact in helping to curb the spread of disease. The fast turnaround means that doctors will be able to screen pregnant mothers and take steps to prevent them from passing the virus to their unborn baby. And the ability to screen donors before they give blood will help to cut transmission through infected transfusions.

Ted Bianco, Director of Technology Transfer at the Wellcome Trust, said: “We are extremely pleased that the product is able to meet the exacting standards required by the EU regulatory agencies. The news marks a significant milestone on the road to getting affordable diagnostic tools into the developing world.”

The group have already launched a rapid test for Chlamydia that is currently sold within the EU and many other countries around the world. Other tests in the pipeline include rapid tests for the detection of HIV and influenza.

Charles Gore, president of the World Hepatitis Alliance, commented: “I am happy this new test has been approved in the EU. Rapid, cheap and robust diagnostic tests are an important component in the battle to prevent and control hepatitis B. This is a battle that is only now beginning to be given the priority it needs with, for the first time, a comprehensive WHO viral hepatitis resolution on the agenda for the World Health Assembly, which coincides with World Hepatitis Day on 19 May.”

Image: Hepatitis virus. Credit: Medical Art Service, Munich/Wellcome Images


Jen Middleton
Wellcome Trust Media Office
020 7611 7262
07534 143849

Notes to editors

Dr Helen Lee is director of the Diagnostics Development Unit and Reader in Medical Biotechnology, University of Cambridge; she co-founded a spinout company, Diagnostics for the Real World, in 2002. She received the Lord Lloyd Kilgerran Award from the British Foundation for Science and Technology in 2005 and was named British Female Inventor in Industry the following year. She also received the European Women of Achievement and Asian Women of Achievement awards and chaired the Diagnostics Steering Committee of the World Health Organization for a number of years.

The Wellcome Trust is a global charity dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust’s breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests.

The World Hepatitis Alliance provides global leadership and supports action that will halt the death toll and improve the lives of people living with chronic viral hepatitis B and C. Through better awareness, prevention, care, support and access to treatment, its ultimate goal is to work with governments to eradicate these diseases from the planet.

The World Hepatitis Alliance is a Non-Governmental Organisation representing more than 280 hepatitis B and C patient groups from around the world. The World Hepatitis Alliance is governed by a representative board elected by patient groups from seven world regions: Europe, Eastern Mediterranean, Africa, North America, Latin America, Australasia and Western Pacific.

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