Antibody test may be approved within days
NHS could begin roll-out of quick, accurate blood check devised by Roche from middle of the month
A Swiss antibody test said to take 18 minutes and have an accuracy rate of 99.8 per cent could be rolled out by the NHS from the middle of May if backed by Public Health England. The test, devised by Roche, has been given US approval and is being assessed by UK scientists who will publish their evaluation by the end of the week. The test for Covid-19 immunity could be produced in the tens of millions and will soon be available in the US and much of Europe, said Roche.
A FIRST coronavirus antibody test could be approved by Public Health England (PHE) within days, with hundreds of thousands available each week if officials give the green light.
Government scientists are currently evaluating the accuracy of a test, made by Roche, which was cleared for use by the US Food and Drug Administration (FDA) on Saturday. They are expected to report their findings by the end of the week, the Swiss manufacturer said last night.
Designed to detect whether a person has previously contracted Covid-19, and therefore likely to be immune from further infection, the technology is considered vital to lifting lockdown.
It could enable family members with a positive result to interact with vulnerable older relatives. Some experts suggest it could be allied to an immunity passporting system.
The Roche test is one of a handful from reputable producers that have secured a European Union CE marking – denoting conformity with health and safety standards – in recent days.
These include Abbott Laboratories, an American producer that has also secured emergency FDA approval, and Quotient, a UK firm, which says it could process 36,000 tests a day. Together, they raise the prospect of widespread access to antibody testing this month.
Prof John Newton, the national testing coordinator, told the BBC: “There has been a lot of work in antibody testing. We are optimistic that we will have a good antibody test when we need it.”
The new 18-minute test, which requires a blood sample to be processed in a laboratory, has an accuracy of 99.8 per cent, says the Basel-based drug-maker. It has already started shipments and says that tens of millions of the antibody tests will soon be available in the US and much of Europe.
Roche says it is already in dialogue with the NHS and could begin a phased roll-out from the middle of this month.
It follows criticism of the Government after it emerged that early promises of quick access to “game changing” antibody finger-prick home testing kits by both politicians and health officials were wildly optimistic.
Some of the candidate tests turned out to have a false-negative rate of up to 75 per cent, once they were examined by PHE. Meanwhile, some European governments were forced to send back millions of testing kits they had ordered from Chinese suppliers that turned out not to work.
Geoff Twist, managing director of
Roche Diagnostics UK & Ireland, said: “Reliable antibody testing is the crucial next step to provide much-needed reassurance to our valued key workers, enabling them to continue providing their vital support.
“It is critical that industry collaborates with the NHS to help alleviate pressures and provide a solution, and we are extremely proud to be able to deliver our high quality antibody test, which will lead to greater confidence as we move into the next phase.”
Siemens Healthineers, a German diagnostics and medical imaging firm, also announced on April 23 that it is producing an antibody blood test.
The tests will be available to large laboratories by late May, the company said, adding that it will be able to provide more than 25 million tests per month from June, thanks to an upgrade to its manufacturing site in Massachusetts. Another antibody test being pioneered by Oxford University could be available by the end of this month, according to Prof Newton.
One of the five testing strategy pillars announced by Matt Hancock, the Health Secretary, widespread access to antibody tests could also ease the dire situation in care homes.
Yesterday, a poll of more than 22,000 health and care workers by the Royal College of Nursing (RCN) – conducted before Mr Hancock announced he had met his target to test 100,000 people a day – suggested that three quarters have not been offered any form of test.
Dame Donna Kinnair, the RCN chief executive, said: “It is concerning to see that some nursing staff, particularly those outside the NHS, are still having issues accessing Covid-19 testing.”