UK antibody testing to be rolled out this week – Med-Tech Innovation | Latest news for the medical device industry

Antibody tests will be available to NHS and care staff, eligible patients and care residents in England to see if they have had Coronavirus as part of a new national antibody testing programme announced by health and social care secretary Matt Hancock.

Tests will be prioritised for NHS and care staff, and clinicians will be able to request them for patients in both hospital and social care settings if they deem it appropriate.

The new antibody testing programme, which will start this week, is supplied by Roche and Abbott.

Geoff Twist, managing director of Roche Diagnostics UK & Ireland, said: “Reliable and accurate antibody testing is the crucial next step in understanding the spread of this virus, and will provide greater confidence and reassurance as we move into the next phase of our collective response to this pandemic.

“We are very proud of the contribution our high-quality antibody test will make to this next phase and we are working with the UK government, and others, to roll out hundreds of thousands of our tests per week to the NHS as quickly as possible.”

Under the programme, laboratory-based antibody tests will be used to tell whether someone has already had the virus, to provide accurate data about the antibodies they have developed in response. The information will help clinicians and scientists to better understand the prevalence of the virus in different regions across the country.

Secretary of state for health and social care Matt Hancock said: “This is an important milestone and it represents further progress in our national testing programme. Knowing you have these antibodies will help us to understand in the future if you are at lower risk of catching coronavirus, dying from coronavirus and of transmitting coronavirus.

“History has shown that understanding an enemy is fundamental to defeating it. In this latest fight, our ingenuity and our brilliant scientists and our scientific curiosity is what will keep us one step ahead of this virus. We all have something to bring though in this fight – one action every one of us can take is to follow the rules on hygiene and social distancing. Not just for you, but for your loved ones and for your community. So please, stay alert, control the virus and save lives.”

Ten million tests so far have been secured and will be rolled out over the coming months, with further agreements being negotiated with suppliers to supply laboratory-based antibody tests.

A positive test result for antibodies, whichever test is used, does not currently mean that the person being tested is immune to COVID-19. There is also no firm evidence that the presence of antibodies means someone cannot be re-infected with the virus or will not pass it on to someone else.

A Public Health England (PHE) study called SIREN is already underway to help answer these questions and establish whether antibodies indicate immunity to COVID-19. A sample of 10,000 healthcare workers is being tested to examine any potential immunity to the virus.

Professor John Newton, national coordinator of the UK COVID-19 testing programme, said: “Our understanding of this virus will only continue to grow as new scientific evidence and studies emerge. This new national testing programme is a very important part of that work.

“COVID-19 is a new disease, and our understanding of the body’s immune response to the virus that causes it is limited. Progress is being made every day, but we do not yet know how long immunity lasts, nor whether having antibodies means a person cannot transmit the virus to others. It is vital that everyone continues to follow social distancing measures, playing their part to halt the spread of infection.”

SIREN study lead, Dr Susan Hopkins, added: “The results of this PHE study will be an important piece of the puzzle. We know people who have had COVID-19 produce antibodies in response but what we don’t know is whether this means they have immunity against future infection and how long that protection may last. Improving our understanding will be critical to future decisions about how best to control the spread of Coronavirus.”

Antibody tests require blood samples, which will be collected by trained staff and analysed by existing pathology labs across England. Data on the number of positive and negative cases will be reported to PHE.

Health and social care staff will be asked by their employer whether they want to have an antibody test. For NHS staff, the NHS in England has set up a network of regional CEOs to oversee this work. The NHS will use existing phlebotomy services and will set up more to ensure all staff can be tested.

Patients who are already having blood taken as part of other tests will be asked whether they would like an antibody test.

Research is underway to understand more about the prevalence of the virus among the UK population through a combination of blood and swab testing in addition to PHE’s immunity study. This is one of a range of surveillance studies under Pillar 4 of the Testing Strategy, including studies by the ONS, Imperial College and IPSOS MORI, and Biobank.

Only lab-based antibody tests with CE marks that have been evaluated by Public Health England (PHE) and shown to provide reliable results will be used in the programme.