Headteachers have warned that the government’s mass Covid testing programme has been thrown into chaos after a medical regulator cast doubt over the plan to keep close contacts of the people with the virus in schools.

The Department for Education (DfE) has told schools that rapid lateral flow tests can be used to keep close contacts of confirmed Covid cases in school, if they test negative, rather than asking them to self-isolate.

However a statement from the Medicine Healthcare products Regulatory Agency (MHRA) says it recommends that close contacts of known Covid cases continue to self-isolate.

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The DfE has asked schools to give daily serial tests to close contacts of Covid cases for seven days and to keep them in school if the results are negative. 

Scientists and public health directors have already warned against using the rapid Covid tests in this way because of concerns that it will provide false negatives, results resulting in people with the virus staying in school.

The regulator put out a statement today which said that this Innova test can be used under trained supervision in a school setting and that this does not need MHRA approval.

However, the MHRA also said that it has not approved the use of the test as self-test device for “serial testing” of school pupils who have been exposed to a confirmed positive Covid case “that would enable them to attend school as normal”. 

It adds: “The MHRA continues to advise that close contacts of positive cases identified using the self-test device continue to self-isolate in line with current guidelines. Discussions with Test and Trace regarding any future exceptional-use cases are ongoing.”

It is unclear if this statement applies to the DfE’s plan, which is to carry out serial testing of Covid contacts in secondary school, under supervision, daily for seven days.

It follows a report last night that the MHRA has told the government it had not authorised the daily use of the 30-minute tests in schools because of concerns that they give people false reassurance if they test negative. 

However the DfE has said that the MHRA has made clear that they do not need to authorise the programme.

Tes has asked for clarification from the MHRA on this matter.

The questions come amid major concerns from public health teams about the way the government plans to use lateral flow tests.

Tes revealed earlier today that local public health directors have been advising schools in some areas of the country that they should not use the rapid lateral flow tests to keep close Covid contacts in school because this could result in undetected cases remaining in contact with other people.

In a document sent to schools and seen by Tes, the DfE has said the MHRA has granted an exceptional use authorisation for self-use of lateral flow tests to be used to help find asymptomatic cases.

It adds: “Schools and colleges are using an ‘assisted testing’ model, where the individual being tested swabs themselves under supervision of a trained operator.”

But the DfE document does not say whether or not the MHRA has approved the use of these tests on close contacts on confirmed Covid cases.

School leaders unions have called on the government to provide clarity on “another chaotic situation”.

Paul Whiteman, general secretary of school leaders’ union NAHT, said: “This is another extremely confusing situation for schools and parents alike. The government may feel that it has been clear about the use of lateral flow testing in schools, but there is enough of a difference between what they have said so far and what the MHRA has said to create another chaotic situation. 

“Both parties must urgently correct this, otherwise the government’s mass-testing plans will be in tatters and schools will, yet again, be left to pick up the pieces.

“NAHT reiterates its call for the government to share the evidence upon which it is basing its decisions and to be completely transparent about its plans. They have routinely failed to do this, and, in doing so, they have harmed schools’ efforts to provide the highest quality of education for the young people in their care.”

Geoff Barton, 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 full MHRA statement says: “The Innova test can be used under trained supervision in a school setting, which means that the test is being used within the manufacturer’s intended purpose. We have provided NHS Test and Trace with some considerations that they need to take account of when deploying tests in this way - including undertaking a risk assessment - but it is not subject to our approval. 

“In December, MHRA provided Test and Trace with an exceptional use authorisation. This permits NHS Test and Trace to deploy the repurposed Innova Covid-19 as a self-test device throughout the UK - as a test to detect infection in asymptomatic individuals, this is known as Test to Find.

“Individuals with a positive test would then be asked by NHS Test and Trace to isolate and to confirm the result with a PCR (polymerase chain reaction) Covid-19 test. 

“The MHRA has not issued an exceptional use authorisation for that self-test device for ‘serial testing’ for school pupils who have been exposed to a confirmed positive Covid case that would enable them to attend school as normal.

“The MHRA continues to advise that close contacts of positive cases identified using the self-test device continue to self-isolate in line with current guidelines. Discussions with Test and Trace regarding any future exceptional use cases are ongoing.”

The DfE’s plan for Covid testing in schools currently has three elements to it. 

• Initial testing of vulnerable pupils and children of critical workers who are on school and college sites (two tests, three to five days apart).
• Weekly testing of staff who are on school and college sites.
• Daily testing of close contacts of positive cases in school and college as an alternative to self-isolation.

The DfE has sent kits out to secondary schools and colleges, and is set to to roll the programme out in primary schools from next week as well.

A government spokesperson said: “Testing is a vital part of our plan to suppress this virus. Along with vaccines, social-distancing measures and new treatments, testing must be consistently and properly used so we can detect cases and break the chains of transmission.

“Schools benefit from extensive and varied testing programmes, including regular testing using the rapid lateral flow test, which has been approved for use in a range of settings, and is already proving beneficial in finding people with coronavirus before they develop symptoms.

“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.”