Schools demand No 10 explain unauthorised use of rapid Covid tests

School leaders have demanded urgent clarity about the government’s flagship mass-testing strategy for schools after the UK’s medicines regulator said daily coronavirus testing should not be used as an alternative to self-isolation.

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 lateral flow tests to allow students to remain in classrooms instead of sending whole “bubbles” home.

The daily testing policy is at the heart of Boris Johnson’s £100bn “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.

The Department of Health and Social Care (DHSC) claimed on Friday that the primary purpose of using rapid testing in schools was to find positive cases and that this did not require the MHRA’s approval, but that it was providing regulatory oversight.

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. Gavin Williamson, the education secretary, said last month: “Testing on this scale brings real benefits to education, it means more children, teachers and staff can stay in their classes in schools and colleges without the need to self-isolate.”

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Geoff Barton, the general secretary of the Association of School and College Leaders, said: “School leaders and staff are utterly tired of this endless confusion over lateral flow tests, alongside much else that has been landed on their plates during this crisis.

“All they want is clarity about what is the right thing to do, and the reassurance that there is a sound scientific basis for what is proposed. What is obvious is that there are severe misgivings in many quarters about the use of lateral flow tests as an alternative to self-isolation for close contacts of positive cases. We call on the government to provide a clear and unequivocal statement on this matter.”

The MHRA said on Friday that anyone who had been in close contact with a positive case who tests negative with a self-administered test should still self-isolate – undermining the core strategy to keep children in schools – but later said this did not apply to schools. The regulator said it was not required to authorise the daily tests used in schools because they were supervised by a trained person, usually a teacher.

There was confusion and anger among headteachers, including those in secondary schools where daily testing was introduced last week.

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.

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.

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 out 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 safe 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.

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.”

A Department for Education spokesman said: “Daily testing of close contacts as a replacement for self-isolation is only possible on test sites in secondary schools and colleges, where a trained member of staff oversees the testing. The MHRA themselves have made clear that they do not need to authorise this programme.

“We continue to evaluate this programme to make sure it is delivering on its aim of keeping students in education while reducing transmission across the community.”