School leaders, MPs and scientists have demanded the government urgently explain its strategy of carrying out daily coronavirus tests on pupils despite the policy not being approved by the UK’s medicines regulator.
Headteachers said they were “alarmed” after the Guardian revealed that the Medicines and Healthcare products Regulatory Agency (MHRA) had not authorised the use of 30-minute tests to be used daily on students.
The daily testing policy is at the heart of Boris Johnson’s £100m “Operation Moonshot” strategy because it allows people who test negative to stay in school or work when they would otherwise have to self-isolate.
However, the MHRA has expressed serious concerns about using the tests in this way and told the government on Tuesday it had not authorised them for this key purpose, although it has allowed the so-called lateral flow devices to be used in other ways.
A senior MHRA official confirmed its position in an email seen by the Guardian on Friday. The official wrote on 29 December that its approval “ONLY allows for the test to be used to ‘find’ positive cases. MHRA HAVE NOT approved the test for use in a ‘test to enable’ scenario” – such as allowing those who test negative to remain in school or the workplace.
The email added: “Any other use of the kit is outside of MHRA’s remit and at the manufacturer’s own risk. We are therefore unable to comment any further on this matter.”
The MHRA made clear the Department of Health and Social Care (DHSC) and Innova, the California-based company that makes the tests, were the “legal manufacturer” of the tests so their use in “test to enable” scenarios such as to allow children to remain in school was at their own risk.
The regulator’s decision undermines a key element of the government’s strategy to bring the pandemic under control – and is bound to raise fresh questions about the tests, and the safety of the schools that have been asked to use them.
Ministers have repeatedly said the use of daily Covid-19 tests is critical to keeping children in education because it means those who test negative can remain in classrooms, instead of whole year groups having to self-isolate.
The use of the lateral flow tests, which take up to 30 minutes to produce a result, has divided experts. Some say they should be welcomed because they can quickly and cheaply identify infected people that would otherwise not have been identified. But others point to their low accuracy and say they risk doing more harm than good, especially when used in the way proposed by government, which is centred on keeping children in schools.
Paul Whiteman, the general secretary of school leaders’ union NAHT, said the government had “serious questions to answer” about its schools testing policy.
“The suggestion that the MHRA have not approved these tests to be used as an alternative to self-isolation is alarming, as that is precisely what the government are suggesting schools should do as part of their testing strategy. The government also needs to urgently explain why it took such an approach if the MHRA approval was not in place,” he said.
“Once again, the government’s confused approach has made it impossible to have confidence in their plans, and is putting school leaders and their communities in a difficult situation.”
Geoff Barton, the general secretary of the Association of School and College Leaders, said he had been pressing the government to publish the scientific basis for its use of these daily tests in schools but had not received an answer.
Barton said the government needed to clarify the situation “as a matter of urgency”.
“Our particular concern is over the government’s guidance that lateral flow tests should be used as an alternative to self-isolation for the close contacts of positive cases, and how this would be safe and effective in minimising the risk of transmission given that our understanding is that lateral flow tests produce a proportion of false negative results.”
The Labour MP Maria Eagle said she had written to the health secretary, Matt Hancock, to explain the “safety and lawfulness” of the daily testing policy, amid concerns about a sharp rise in cases at a Jaguar Land Rover site in Merseyside that has been carrying rapid testing of workers.
Prof Jon Deeks, a biostatistician of the University of Birmingham, said: “It’s clear that the regulator has agreed this is not a sage way of using these tests. We urgently need clarity from the government about what their mass-testing plans are for the future. It’s important for schools, teachers and children to know what the position is.”
The government has spent at least £1.5bn on the lateral flow devices and they have been used by universities, care homes and hospitals. Ministers announced this week they would be distributed to all 317 local authorities in England.
DHSC has been contacted for comment. In a statement on Thursday night, it said: “Lateral flow devices are a vital tool to finding more asymptomatic cases and the government’s approach to testing in schools will reduce transmission. We are testing teachers and students weekly on site to find positive cases and break the chains of transmission. In addition, as part of an ongoing evaluation, we are doing daily contact testing in schools using an assisted testing model.
“The evidence and lessons from these and other evaluations will be used to inform our review of the effect of daily contact testing on breaking chains of transmission and any future plans.”