Good news: industry heavyweights are combining to bring antibody tests to British public
Britain could be about to get reliable antibody tests for coronavirus. An accurate and rapid test detecting antibodies to the new coronavirus has now been developed as the government seeks to continue to increase its testing efforts.
This development should allow antibody testing devices – known as lateral flow immunoassays (LFIAs) – to be used remotely across the country, enabling tests to be carried out not only in laboratories but also in homes and GP surgeries. It would also cut down the time required to get a result back from an antibody test from hours to just 18 minutes.
A new antibody test kit has been approved by Public health England, it was revealed today. Made by the Swiss diagnostics heavyweight, Roche, the kit has now been confirmed by Public Health England to have met its exacting accuracy standards.
The Daily Telegraph reported that the government is now in negotiations with Roche to acquire as many of the tests as possible. Geoff Twist, the managing director of Roche Diagnostics UK and Ireland, has also confirmed that he will be working with the British government and the NHS to get the test rolled out for public use as soon as possible.
The accuracy of the new antibody test was verified by PHE after Roche released results from its own validation tests last week, which showed that the company’s test kit had a specificity of greater than 99.8% and sensitivity of 100%. This comfortably met the specifications of the Medicines and Healthcare products Regulatory Agency (MHRA) that any antibody test must have 98% on both of these measures before being approved for use in community testing.
This means that the test is unlikely to provide false positives or false negatives, where the kit either fails to pick up the presence of antibodies or accidentally indicates that people have antibodies when they in fact do not.
“Thanks to the enormous efforts of our dedicated colleagues we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the COVID-19 health crisis,” said Severin Schwan, CEO Roche Group.
“I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis.”
Beyond Roche, there are also UK-based firms, such as Mologic and BioSure, which have now combined to bring game-changing antibody tests closer to the stage at which they can be approved for use by the British public.
Mologic is a world-leading developer of pregnancy tests. In 1988 it invented and launched the Clearblue pregnancy test, the world’s first commercial application of the lateral flow immunoassay technology.
The company is now teaming up with BioSure, a younger diagnostics manufacturer specialising in disruptive technology and the provision of rapid point of care testing. In 2015, BioSure designed the world’s first approved blood-based self-test for HIV.
On Monday, BioSure and Mologic announced that they had combined Mologic’s independently verified antibody test with BioSure’s design to produce a kit that could provide a test within 10 minutes.
The firms confirmed that, if final validation tests confirm the accuracy of the tests: “The BioSURE COVID-19 Antibody Self-Test will be ready for mass production at the beginning of June. It will be available to the UK and global markets but it will also be available to be directly purchased by end-consumers.”
The antibody tests have been called a “game changer” by the government’s Chief Scientific Adviser, Patrick Vallance, and by the Prime Minister, Boris Johnson. Antibody testing is widely believed to represent a key means by which Britain can begin easing the lockdown, allowing for the pandemic to be better managed and providing a reliable device with which immunity to the coronavirus can be monitored.
Since March, both the public health authorities and the government have sought to find and develop an antibody test suitable for general use across the country. But this ambition was frustrated after it was discovered that the antibody tests which the British government had purchased from a Chinese company in late March failed to meet PHE’s standards.
Over the last month, private companies have worked to rapidly improve the accuracy of antibody tests. After the disappointments of April, it looks as if effective and widespread antibody testing may finally be within reach of the health authorities and the British public.
Read more – Why developing an antibody test for coronavirus is almost as important as finding a vaccine.