Date of prep: December 2020
Prescribing information and
adverse events reporting
For healthcare professionals only
Professor John Newton, the national coordinator of the UK coronavirus testing programme, has warned against the purchase of unapproved antibody testing kits.
Professor John Newton has warned that unapproved tests could be misleading, by providing inaccurate or inconsistent results, potentially putting those tested and those around them at risk.
The government has said that it is currently working with several companies who are offering these tests and are evaluating their effectiveness. However, so far, the antibody tests that have gone through the validation process have not proven accurate enough to be rolled out for public use, which is why the government has said that it is backing industry efforts to develop a homegrown test.
Professor John Newton, the National Coordinator of the UK Coronavirus Testing Programme, said:
“The government, supported by world-leading experts and regulators, is continuing to work hard to rapidly deliver a reliable and accurate back-to-work antibody testing kit, to counter the spread of the virus and enable people to return to work safely. We are breaking new ground with this work every day and I am confident this major research effort will make a breakthrough. Until then, please don’t buy or take any unproven tests. They may not be reliable for your intended use; they may give a false reading and put you, your family or others at risk.
“Testing is an important part of our war against coronavirus. At the moment we have swab testing that can tell you if you currently have coronavirus – for these tests a swab sample is taken and analysed in a lab. These tests are available to people in clinical need and we are also providing them to more and more key frontline workers such as NHS staff and care workers, so that they can stop self-isolating and return to work if the test comes back negative.
“There is another kind of test, an antibody test, which is a blood test designed to tell whether people have already had the virus and are now immune. We know they work best around a month after someone has had the virus. These could maybe be done at home with a finger prick, and deliver results in as little as 20 minutes. Such a test could, if developed in such a way that they could be reliably used at home and be sufficiently accurate, be a game-changer.
“Right now, however, these antibody tests are brand new and still in development. No country in the world has yet found an antibody test reliable enough to work as a back-to-work diagnostic, but the UK is leading the way in this emerging area of science and technology, and companies and scientists are doing everything they can to improve the accuracy of the tests on the market. As soon as we have found a test that works for this purpose, we will be in a position to roll them out across the country as a back-to-work test.
“In the meantime, I advise organisations, both in the public and private sector, against the use of antibody tests that have not been verified in a laboratory setting: and none have. The results of an inaccurate test are potentially misleading and can put people at risk of contracting the disease and transmitting it to others. The Chief Medical Officer has also said he strongly discourages the use of unvalidated tests and that, for now, the social distancing guidelines continue apply to everyone.”
This circular is being shared under the Open Government Copyright licence.
Pharmacy in Practice is a UK pharmacy publication with its roots in Scotland.