The pharmaceutical giant Roche has devised a new coronavirus antibody test, which it is aiming to launch in the UK next month.
Antibody testing, which has already been utilised in Germany, South Korea and Finland, is seen as a way for countries to exit lockdown by showing who has already had Covid-19 and could therefore have a degree of immunity.
Roche, which has its headquarters in Switzerland, says it will be able to produce its tests in the order of the high tens of millions by June and will then scale up production “as fast as possible”.
Geoff Twist, managing director of Roche Diagnostics UK and Ireland, said: “Roche Diagnostics has been working around the clock to develop a high-quality antibody test. We are now collaborating with public health bodies to validate the new antibody test and our aim is to commence a phased rollout across the UK from mid-May.
“More than ever it is critical that industry works collaboratively with the NHS to help alleviate pressures and provide solutions – and once again this has enabled us to move extremely quickly.”
The UK government has previously cited antibody tests as a possible route to relaxing restrictions on movement and social distancing but has yet to identify any that are sufficiently accurate. It ordered 3.5m last month but they proved to be unusable because they were unreliable.
Experts at Oxford University leading the UK’s testing effort say the best ones spotted immune cells only 70% of the time, whereas accuracy would have to be nearer 95% for them to pass muster.
Last month, Prof Sharon Peacock, director of infections at Public Health England, told MPs that millions of home-testing kits would be available within days, only for the chief medical officer, Prof Chris Whitty, to quash the idea hours later, citing concerns about accuracy.
Announcing its plans on Friday, Roche did not specify the accuracy of its Elecsys serology test but a spokesperson said it was “comfortable with the high performance data that we are seeing and will share the specifics closer to the time of launch”.
It said it would be available to countries accepting the CE mark, which signifies that products sold in the European Economic Area meet the requisite standards, and it is also working with the US Food and Drug Administration for an emergency use authorisation.
Roche joins US-based Abbott Laboratories and Becton Dickinson and Co alongside Italy’s DiaSorin in a race to produce an antibody test for coronavirus that is sufficiently accurate. The clamour for such a test has grown despite the fact that, because it is a new virus, no one knows how long immunity will last.
If the test is sufficiently accurate, it is likely it will be rolled out to frontline healthcare workers first, to enable them to return quicker from isolation, assess their suitability for working in high-risk environments and their need for personal protective equipment, which has been in short supply. Testing could then be extended to other key workers and potentially the wider population.
Simon Clarke, associate professor in cellular microbiology at the University of Reading, said: “This is a very interesting and potentially important advance … but I think the authorities in the UK would be wise to conduct independent evaluation, given how they’ve had their fingers burned with other tests that they’ve purchased.
“Moreover, this test will require space and manpower in testing laboratories in addition to equipment already made by the manufacturer. It remains unclear how quickly laboratories that do not already have that particular instrument would be able to obtain them and at what cost.”
