Hepatitis B dipstick test approved

A ’dipstick’ test that detects Hepatitis B within 30 minutes – and could be used in some of the world’s poorest countries – has been given the green light for use in the EU.

Developed by Cambridge University researcher Dr Helen Lee, the inexpensive test delivers accurate while-you-wait results and allows doctors to take immediate action – circumventing the need to send samples away for laboratory analysis.

With around 400 million people worldwide estimated to carry the disease, the Hepatitis B Rapid Test could revolutionise detection of the condition in poorer countries.

Dr Helen Lee from Diagnostics for the Real World (DRW), 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.’

Dr Lee, who works at the university’s Diagnostics Development Unit, set up DRW in 2002. The group has 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.

Hepatitis B virus (HBV) is highly infectious and is endemic in many parts of the world. In the UK alone, one in 1,000 people are infected and in China and Africa as many as one in six people carry the virus. Spread through contact with infected blood or other body fluids, including sexual contact, infection rarely kills but can cause serious health problems and places enormous strain on healthcare resources.

Compared with existing diagnostics, which involve sending patient samples away to laboratories for analysis by skilled technicians using expensive machinery, the new Hepatitis B Rapid Test, developed with funding from the Wellcome Trust, uses dipstick technology to deliver an accurate diagnosis on-site within half an hour and can be used with minimal training.

According to Prof Baruch S Blumberg, who was awarded the Nobel Prize for Medicine in 1976 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.’