The Department for Education's plan to use rapid Covid tests to keep close contacts of confirmed cases of the virus in schools if they test negative goes against the manufacturer's own instructions, a leading headteacher has warned.
Instruction notes for the Innova Covid tests being used in secondary schools and colleges say that negative test results should "not be used as the sole basis for infection control decisions...for those who have been in contact with the virus".
The NEU teaching union's president, Robin Bevan, said these instructions directly contradict the DfE plan, which is to keep close contacts of Covid cases in secondary school if they test negative, rather than asking them to self-isolate.
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There is growing controversy over the use of these lateral-flow tests for serial testing of Covid contacts in secondary schools.
Tes revealed on Friday that public health directors in some areas of the country were advising schools not to use the tests in this way, as the DfE has instructed, but to continue sending pupils or staff home to self-isolate if they come into contact with the virus.
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There are concerns that the lateral-flow tests will give false negatives, meaning people with Covid remain in schools.
Mr Bevan told Tes that the DfE plan to use the tests to allow people who are close contacts of a Covid case to remain in school was at odds with the instructions.
The instructions for the Innova SARS-CoV-2 Antigen Rapid Qualitative Test state: "Negative results are presumptive. Negative test results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions, including infection control decisions, particularly in the presence of clinical signs and symptoms consistent with Covid-19, or in those who have been in contact with the virus.
"It is recommended that these results be confirmed by a molecular testing method, if necessary, for patient management control".
Mr Bevan, who is the headteacher of Southend High School for Boys, said: “It is a matter of very serious concern that the DfE planned – and continues to advocate – using these tests to make decisions about whether to keep people in schools and classrooms, even after they have been identified as having close contact with the virus.
"The manufacturer’s own instructions expressly rule out using the tests in this way. It’s as if they never read the ‘directions for use’.”
The Department for Education and Innova Medical Group have been approached for a comment.
Meanwhile, the Medicines and Healthcare products Regulatory Agency (MHRA) has now confirmed to Tes that the DfE's plan to use lateral-flow tests under supervision in secondary schools does not need its approval.
The confirmation follows confusion after the regulator issued a statement which said that it had not issued 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".
However, Tes understands that this statement applies to people using the kits to self-test rather than under supervision.
The DfE said on Friday that the medical regulator did not need its plans for testing in schools, and the MHRA has confirmed this.
An MHRA spokesperson said: "The Innova device can be used in schools under supervision. While MHRA provides advice to NHS Test and Trace on its use, its use is not subject to MHRA approval."
When asked by Tes if the MHRA would advise secondary schools to follow the DfE plan to use these tests to keep close contacts of Covid cases in schools rather than self-isolating, a spokesperson added: "It is the responsibility of the organisation procuring and deploying medical devices to satisfy themselves that the tests will be safe and perform as intended in the context in which they are being used."