MHRA approval not needed for key part of schools testing plan, government says

The government has told schools regulatory approval is not needed for a key part of their testing plan aimed at keeping students in classrooms.

Under a new scheme, close contacts of a positive coronavirus case can continue going into school and avoid self-isolating, if they choose to take a daily rapid coronavirus test and get a negative result.

The Guardian reported earlier this week the Medicines and Healthcare Products Regulatory Agency (MHRA) had not given approval for this plan – which experts have warned could keep infected people in school amid concerns over device accuracy.

In an email sent to education providers, seen by The Independent, the Department for Education (DfE) sought to reassure them. 

“The MHRA has been clear that we do not need MHRA regulatory approval to carry out daily testing, as long as people are assisted when processing the tests,” a Department for Health and Social Care (DHSC) spokesperson comment circulated in the email said. 

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“Daily testing taking place in secondary schools is assisted testing, and therefore does not require MHRA approval.”

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Assisted Covid-19 testing is when someone swabs themselves under the supervision of a trained operator – who then processes the result. 

This model – also used across universities and in the Liverpool pilot – is sufficiently close to the manufacturer’s instructrutions and therefore MHRA authorisation is not needed, the DHSC said.

An MHRA spokesperson confirmed to The Independent its approval was not needed for the planned use of rapid tests in schools.

Scientists warned earlier this week serial testing of close contacts could increase cases in schools as “the possibility that some close contacts who are infected will test negative and will spread the virus is not negligible”.

“Scientists have particular concerns that negative Innova (lateral flow tests) results are too inaccurate to rule out Covid,” experts wrote in a British Medical Journai article earlier this week.

These rapid coronavirus tests failed to identify up to 50 per cent of positive infections when deployed in Liverpool’s mass testing pilot last year, according to the government’s own analysis published in early December.

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Researchers also estimated around 60 coronavirus cases were missed from University of Birmingham students who got tested before returning home for Christmas with LFDs, while only two infections were picked up. 

In November, the government said extensive clinical evaluation from Public Health England (PHE) and the University of Oxford show lateral flow tests were accurate and sensitive enough to be used in the community, including for asymptomatic people.

“Lateral flow devices (LFDs) are a vital tool to finding more asymptomatic cases and the government’s approach to testing in schools will reduce transmission,” the DHSC spokesperson comment in the email to education providers said.

An MHRA spokesperson said: “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. ”

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