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

The Government is making the same mistakes as it did in the first wave. Except with knowledge.

A thread.


The Government's strategy at the beginning of the pandemic was to 'cocoon' the vulnerable (e.g. those in care homes). This was a 'herd immunity' strategy. This interview is from


This strategy failed. It is impossible to 'cocoon' the vulnerable, as Covid is passed from younger people to older, more vulnerable people.

We can see this playing out through heatmaps. e.g. these heatmaps from the second


The Government then decided to change its strategy to 'preventing a second wave that overwhelms the NHS'. This was announced on 8 June in Parliament.

This is not the same as 'preventing a second wave'.

https://t.co/DPWiJbCKRm


The Academy of Medical Scientists published a report on 14 July 'Preparing for a Challenging Winter' commissioned by the Chief Scientific Adviser that set out what needed to be done in order to prevent a catastrophe over the winter
They shouldn't be.

The pattern is:
GOP in power - GOP dictates policy

Dems in power - GOP dictates policy


The Dems shouldn't legislate toward the GOP.

The GOP doesn't represent its constituents.

The GOP can push it's agenda on its own time.

If Dems push an agenda that actually helps people, it'll also actually help the GOP constituency.

The GOP won't. So give them nothing.

The Dems should ignore the GOP just like the GOP ignores the Dems.

Make them pay for every moment of obstruction.

Just a hard press on legislation that is unassailable and shine a light on the GOP.

Constant. Relentless. Unyielding.

Shut them out and shut them down.

The GOP is not a legitimate political party. It is an anti-democratic, fascist criminal syndicate with no interest whatsoever in governance.

Nobody should give them the slightest bit of credit or legitimacy ever again.

Not a fucking ounce.

Nobody should engage them in legitimate debate in Congress.

They should be pariahs and treated as unserious occupants of Congress.

Because these people were totally ok with their colleagues being killed in furtherance of the destruction of the insitution.

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