A home finger-prick test for COVID-19 has been developed which could be offered to millions of people if checks show that it is effective. The test detects antibodies to the SARS-CoV-2 virus and a positive result would indicate prior exposure to the virus and immunity.
We are all navigating unchartered waters as business and society faces up to the impact of COVID-19. We very much hope you and your loved ones remain in good health.
Please be assured that Fieldfisher is continuing to work with clients to navigate COVID-19 related issues and on business as usual needs. Do get in touch with us if you would like to chat anything through.
The UK government have reportedly purchased 3.5 million of the tests and Professor Sharon Peacock, of the National Infection Service at Public Health England, told MPs this week that the kits, which are currently undergoing laboratory tests, should be ready for use in a matter of days. However, the UK government's Chief Medical Officer told a Downing Street press conference on Wednesday that full testing would need to be carried out on the tests first. Understandably, false positives could lead to dangerous outcomes.
Those who have been tested could be allowed back to work if they have had the virus and developed immunity, allowing the UK to gradually ease out of the lockdown.
Modelling by Oxford's Evolutionary Ecology of Infectious Disease Group recently suggested that the virus may already have infected half the UK population. The research presents a significantly different view to the modelling performed at Imperial College that has influenced recent Government policy. If these results are confirmed, they imply that fewer than 1 in 1,000 of those infected require hospital treatment, with the vast majority developing mild symptoms or none at all. Professor Sunetra Gupta, who led the study, says that large scale antibody testing will allow researchers to assess what stage of the epidemic we are currently in. If the Oxford results are confirmed, the current restrictions could be removed sooner than ministers had anticipated.
At present, NHS staff are not being tested for the virus and are being sent home to self-isolate for seven days if they develop a continuous cough or a fever of >37.8, and 14 days if a household member shows symptoms. However, failing to test healthcare workers could mean that these isolation policies are unnecessarily leading to a diminished work force, with NHS staff being required to stay at home without confirmation that they have in fact been infected. NHS chiefs have said they want to start testing frontline staff within days.
The MHRA and Public Health England (PHE) have recently clarified that the diagnostic kits would fall under the in vitro diagnostic (IVD) directive. Although diagnostic tests are not subject to the same stringent safety testing requirements as therapeutics or vaccines, the guidelines make it clear that any test for COVID-19 that will be put to use in the UK must undergo a review by PHE first.
Manufacturers can apply to fast-track approval for an IVD test by submitting their proposal to PHE. If PHE considers the test suitable for use in the UK and it is not already CE marked, manufacturers can then apply to the MHRA for approval to supply a device that does not comply with the regulations, allowing for a much shorter timeline from laboratory testing to market. Manufacturers will be expected to supply evidence that the device performs as intended, i.e. confirmation of PHE approval.
Special thanks to Emily Lockey, trainee solicitor for this article.
We are all navigating unchartered waters as business and society faces up to the impact of COVID-19. We very much hope you and your loved ones remain in good health.
Please be assured that Fieldfisher is continuing to work with clients to navigate COVID-19 related issues and on business as usual needs. Do get in touch with us if you would like to chat anything through.
The UK government have reportedly purchased 3.5 million of the tests and Professor Sharon Peacock, of the National Infection Service at Public Health England, told MPs this week that the kits, which are currently undergoing laboratory tests, should be ready for use in a matter of days. However, the UK government's Chief Medical Officer told a Downing Street press conference on Wednesday that full testing would need to be carried out on the tests first. Understandably, false positives could lead to dangerous outcomes.
Those who have been tested could be allowed back to work if they have had the virus and developed immunity, allowing the UK to gradually ease out of the lockdown.
Modelling by Oxford's Evolutionary Ecology of Infectious Disease Group recently suggested that the virus may already have infected half the UK population. The research presents a significantly different view to the modelling performed at Imperial College that has influenced recent Government policy. If these results are confirmed, they imply that fewer than 1 in 1,000 of those infected require hospital treatment, with the vast majority developing mild symptoms or none at all. Professor Sunetra Gupta, who led the study, says that large scale antibody testing will allow researchers to assess what stage of the epidemic we are currently in. If the Oxford results are confirmed, the current restrictions could be removed sooner than ministers had anticipated.
At present, NHS staff are not being tested for the virus and are being sent home to self-isolate for seven days if they develop a continuous cough or a fever of >37.8, and 14 days if a household member shows symptoms. However, failing to test healthcare workers could mean that these isolation policies are unnecessarily leading to a diminished work force, with NHS staff being required to stay at home without confirmation that they have in fact been infected. NHS chiefs have said they want to start testing frontline staff within days.
The MHRA and Public Health England (PHE) have recently clarified that the diagnostic kits would fall under the in vitro diagnostic (IVD) directive. Although diagnostic tests are not subject to the same stringent safety testing requirements as therapeutics or vaccines, the guidelines make it clear that any test for COVID-19 that will be put to use in the UK must undergo a review by PHE first.
Manufacturers can apply to fast-track approval for an IVD test by submitting their proposal to PHE. If PHE considers the test suitable for use in the UK and it is not already CE marked, manufacturers can then apply to the MHRA for approval to supply a device that does not comply with the regulations, allowing for a much shorter timeline from laboratory testing to market. Manufacturers will be expected to supply evidence that the device performs as intended, i.e. confirmation of PHE approval.
Special thanks to Emily Lockey, trainee solicitor for this article.