The government told schools An important part of their testing plan, which is aimed at keeping students in classrooms, does not require government approval.
Under a new scheme, close contacts of a positive coronavirus case can still go to school and avoid self-isolation if they opt for a daily rapid coronavirus test and get a negative result.
The guard Earlier this week, the Medicines and Health Products Regulatory Authority (MHRA) reported that it had not approved that plan. Experts have warned that infected people could stay in school due to concerns about the accuracy of the devices.
In an email to education providers, seen by The independent onethe Ministry of Education (DfE) tried to calm her down.
"The MHRA is clear that we do not need official approval from the MHRA to carry out the daily tests, as long as the employees are supported in carrying out the tests," said an email from a spokesman for the Ministry of Health and Social Affairs (DHSC ).
"Daily tests that take place in secondary schools are assisted testing and therefore do not require MHRA approval."
With assisted Covid-19 tests, someone is swabbed under the supervision of a trained operator, who then processes the result.
This model – which is also used across universities and in the Liverpool pilot project – is close enough to the manufacturer's instructions that MHRA approval is not required, the DHSC said.
An MHRA spokesman confirmed this The independent one Your approval was not required for the planned use of rapid tests in schools.
Scientists warned against serial testing of close contacts earlier this week could increase cases in schools as "the possibility that some close contacts that are infected will test negative and spread the virus is not negligible".
"Scientists have particular concerns that negative Innova results (lateral flow tests) are too imprecise to rule out Covid," wrote experts in a British Medical Journai Article earlier this week.
In November, the government announced that extensive clinical evaluations from Public Health England (PHE) and Oxford University show that lateral flow tests are accurate and sensitive enough to be used in the community, including on asymptomatic people.
"Lateral Flow Devices (LFDs) are an important tool for finding more asymptomatic cases and the government's approach to testing in schools will reduce transmission," the DHSC spokesman said in the email to education providers.
An MHRA spokesperson said: “The Innova test can be performed under trained supervision in a school, which means that the test is used within the purpose intended by the manufacturer. We have provided NHS Test and Trace with a number of considerations that need to be taken into account in providing tests in this way – including performing a risk assessment – but which are not subject to our approval. ”