MHRA exceptional authorisation of Innova for asymptomatic individuals was issued on 22nd Dec.

This is a LIMITED approval, and the details of how and why it is LIMITED are important. It does not cover all current uses of INNOVA by

Details here have been provided by the @MHRAgovuk by email. If any fact is incorrect here @DHSCgovuk @MHRAgovuk please let me know and I will change – it is a bit complicated and rather unusual.

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First, approved test is called the “NHS Test and Trace COVID-19 Self-Test kit” - the LFT test in it is the INNOVA test.

Second, the test manufacturer is stated as “Department of Health and Social Care”, and not Innova.

This determines who has the duty of care and safety.

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MHRA confirmed details of the limited approval by email (their emphasis):

“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.”

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MHRA continue:

“as stated on our webpage, people should not act on a negative result and should continue to follow their local guidelines.”

“Any other use of the kit is outside of MHRA’s remit and at the manufacturer’s own risk.”

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