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Why, oh why, in these interviews, doesn't anybody ever say there are (or will be) better tests available soon. Don't these journalists know anything about the lateral flow test market? It's enough to drive you crackers listening to a piece like that and nobody ever mentions the alternatives...absolutely crazy.

Sorry AgentB, I too feel a little disappointed with Sonia. Our relationship was only one email old, but I felt we were really bonding. And now that spoilsport Ndn says I’m not allowed to see her anymore, something about her being an enima friend…another deeply penetrating judgement by him. Still, if I had a chance to educate her about anything, I could think of more exciting subjects than asymptomatic testing, lovely looking lady that she is :-)

Talk Radio - Discussion on Innova/FDA about to start 4:35pm

https://talkradio.co.uk/radioplayer/live/talkradio.html

My new bezza, Sonia, discussing Innova/FDA on Talk Radio today at 4:35pm

https://twitter.com/sonia_elijah/status/1403326331669127175

Just to emphasise the point, the results of PD phase 4 evaluation of Innova:

Test conducted by laboratory scientists 79.2% sensitivity
Test conducted trained healthcare-workers 73.0% sensitivity
Test conducted by self-trained members of the public 57.5% sensitivity

Bear in mind these results are based on optimal NP sampling (as per test design), so will be significantly lower when using AN sample, especially now it is being used as self-test AN sample.

Compare that to Affidx specifically designed as AN test - 100% sensitivity at ct<27.

"But the innova test was still tested in Porton down, and UK government had results. Etc"

Yes, @Scarabbeatle, and these were the PD phase 4 results:

Phase 4 evaluation
A further series of individuals were recruited from consecutive cases from COVID19 Testing centres with tests
performed by self-trained individuals and the results were compared to the Phase 3b shown above. Performance
was optimal when the LFD was used by laboratory scientists (156/197 LFDs positive [79.2%, 95% CI: 72.8-84.6%])]
versus trained healthcare-workers (92/126 LFDs positive [73.0%, 95% CI: 64.3-80.5%]) and self-trained members
of the public given a protocol (214/372 LFDs positive [57.5%, 95% CI:52.3-62.6%]; p<0.0001 chi2(2)=30.1) (Figure 3)

https://www.ox.ac.uk/sites/files/oxford/media_wysiwyg/UK%20evaluation_PHE%20Porton%20Down%20%20University%20of%20Oxford_final.pdf

In other words, very poor.

@CO.
Why would UK this, UK that, and UK the other be a massive selling point in Europe - the UK and EU are at daggers drawn right now.

He's just basically listed everything the UK govt have asked for and now he's saying "do you want it or not?"

- Excellent performance
- ease of nasal sampling
- developed in the UK, is
- based on UK technology
- manufactured in the UK

This is a definite "the balls in your court" statement from AS to UK gov.
Old Smiffy is a very clever man!

He may as well have said "...are huge selling points for customers in Europe, but not for the UK apparently." Love it!

"This excellent performance and ease of nasal sampling, coupled with the fact that the AffiDX test is has been developed in the UK, is based on UK technology and is manufactured in the UK, are huge selling points for customers in Europe."

Lovely sideswipe at the UK govt. He may as well have "...are huge selling points for customers in Europe, but not for the UK apparently." Love it!

As if anybody gives a flying fukc Bigzero.

"As part of the study the same clinical samples were tested with two leading, commercially available lateral flow antigen tests, and the data show that the AffiDx® test has superior clinical sensitivity across the range of samples and in particular at lower viral loads."

Was thinking about this last night @Timster. I was asking myself why AS chose to do this. If they haven't published the details of the 'other' tests, then why bother doing it at all? It occurred to me that AS has done this to persuade a third party (UK govt) that despite Affidx not being suitable for PD validation (frozen samples etc.), we are in fact better than other tests that have been through PD. I think this could be an AS masterstroke.

With the MHRA already having reservations about the Innova EUA, you have to think they would be extremely reluctant to renew it after this FDA decision. Their reputation is on the line with this one. Would they really want to set themselves up for a potentially major embarrassment.

I notice that Porton Down 3b study gets a mention in the FDA Innova complaint letter.

"This PPA (Positive Percentage Agreement) for the 7T Configuration devices does not appear to align with the PPA observed in the phase 3b prospective clinical study conducted in the United Kingdom. Accordingly, the clinical performance estimates reported in the labeling of the 25T Configuration and 7T Configurations devices are false or misleading as they do not accurately reflect the performance estimates observed during the clinical studies of your devices."

@Ndn. I'm sure the wider public are perfectly capable of understanding the difference between a good LFT and a poor one. In her article, Sonia Elijah is exposing the Innova test as not being fit for purpose, not LFT's in general. The clue is in the title - "The Innova tests: another Covid scandal in the making?". Sure, LFT's will take a bit of 'innocent bystander' flak, but getting this poorly performing test taken off the table has far more value to the British diagnostics cause (and Avacta's future), than any implied general LFT negativity.

Also, if she were anti-LFT in general, why would she have just re-tweeted the below post from one of her followers:

"@sonia_elijah Many congrats on your article. This is a national scandal especially since the British Avacta test, the most accurate in the world, has been cold shouldered for months."

Sounds like she's supportive of the Avacta LFT to me.

Friday FOMO on steroids tomorrow.

If you're missing our resident poet laureate, I find that fun-time-swing has a very similar style of prose.

https://twitter.com/MDaaaamon

Sonia just retweeted the Innova FDA story to:
@talkRADIO
@JuliaHB1 (Julie Hartley Brewer)
@mrmarkdolan
@GBNEWS (Andrew Neil)

This sheets hitting the fan!

Tis lady doesn't waste any time!

--------------------------------------------------------------------------------
From: SoniaElijah [mailto:SoniaElijah@protonmail.com]
Sent: 10 June 2021 21:13
To: **********
Subject: Re: The Innova tests: another Covid scandal in the making? Part 2

Thank you Martin for your email and for your kind words.

It does seem like perfect timing of my report and the FDA's recall. I will be updating part 3 to reflect this.

Best wishes,

Sonia

Sent with ProtonMail Secure Email.

Actually, Sonia is already on to it.
https://twitter.com/sonia_elijah/status/1403081764931788810