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.

2/8
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.

3/8
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.”

4/8
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.”

5/8
This indicates that MHRA experts have reviewed the evidence, and decided, like many others (WHO, CMO, SAGE, Royal College of Pathologists and summarised here https://t.co/nJP8YxE3pD) that the inaccuracy in the test is too high for it to be approved as a “rule out” test.

6/8
However, @DHSCgov continues to use the test in “test to enable” scenarios – visiting in care homes, students safely travelling to and from University, school pupils remaining in class after being in exposed to a close contact, lorry drivers returning to France.

7/8
Any situation where people act because they have a negative result is a "test-to-enable" situation.

Given @MHRAgovuk has explicitly stated the test is not approved for this, the Government must now take notice (and not by tortous act/not act logic). Our health is at risk.

8/8
@threadreaderapp unroll

More from Government

Canada is failing to act on Climate Change. @wef @WorldBank @IMFNews @IPCC_CH @UNDPGAIN @AntiCorruptIntl @Pontifex @JustinWelby @OCCRP @StopCorpAbuse @TaxJusticeNet @FairTaxCanada @ecojustice_ca @WCELaw @CanEnvLawAssn @envirodefence @IBA_Canada #cdnpoli


Covid recovery money is going to the oligarchy.

Ottawa and the provinces have put very little on the table to help clean-tech companies directly during Covid 19 while targeting fossil-fuel producers with more than $16 billion in aid.

Coast to coast people have demanded treaties be honored. We demanded climate action, divestment and land back but Canada is not listening. This video shows 10 years of rallies in Waterloo Ontario. City & regional council declared a climate emergency. 🚨

The Bank of China (BOC), SNC-Lavalin and WE Charity were recipients of taxpayer-funded the Covid 19 Canadian Emergency Wage Subsidy (CEWS)
Caveat: This article is sourced from @Daily_Express !!!

"End of Sturgeon?"

Frankly, an appropriate response from @NicolaSturgeon might be to quote the infamous Mark Twain response to an erroneous 'obituary' known to all...

"The reports of my demise are greatly exaggerated."

https://t.co/Ce1xVVISR2

More accurately, the media have quoted:

"Ms Sturgeon said she had a “real job to do” and was focused on guiding Scotland through the Covid-19 pandemic."

It's very reassuring to hear that @scotgov and @ScotGovFM have prioritised safeguarding lives and Scotland, above all else.

"I’ll leave others to play games or politics. I have got a real job to do and people can decide themselves whether I am doing it well or not, but I am absolutely 100 per cent focused on leading this country through a pandemic."

💯% 😀👍

Making her priorities crystal clear!

“That’s what I’ve done since this time last year and it’s what I’m going to continue to do for absolutely as long as necessary.”

And again, making it absolutely crystal clear!

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