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"In the last RNS that's what he was trying to tell us discreetly, that we are ready and our product is ready
"Within the presentation the Company provides indicative guidance on timelines for product evaluations, product supply, potential timing for first commercial sales and targeted production volumes."
But he can only officially announce it on Monday, but as last time the other company have already leaked out the information, b y starting to sell it already
Happy days"
Let's put this canard to bed (to mix my metaphors)...
- The test that is currently on sale is the Visitect (Mologic) Triple Antibody (IgG, IgA, IgM) test - not the UK-RTC test.
- The Visitect Triple Antibody test is a CE marked professional use only POC test. All the proceeds from this (bar a small license fee) go to ODX.
- The UK-RTC test has been CE marked for professional POC use and is currently being offered for pre-ordering (via CIGA on behalf of the consortium). When sales are made (which are dependent indirectly on any government order) ODX, as a member of the consortium, will get a share of the proceeds - not the whole lot.
- We are awaiting MHRA approval for the UK-RTC test for self-use, which is tied in with the government confirming any order. When any government order is placed ODX, as a member of the consortium, will get a share of the proceeds - not the whole lot.
In the last RNS that's what he was trying to tell us discreetly, that we are ready and our product is ready
"Within the presentation the Company provides indicative guidance on timelines for product evaluations, product supply, potential timing for first commercial sales and targeted production volumes."
But he can only officially announce it on Monday, but as last time the other company have already leaked out the information, b y starting to sell it already
Happy days
"It is marked for professional use / non public use which is why is can only bought in the packs. This is a way around the rules."
It's not "a way round the rules". It *is* the rules - that's how the CE marking of medical devices works.
Get ready to fasten your seat belts, we are about to take off :)
We will open higher than 100p imho
Been up since 4 am wales time , am I that excited for news here ?
Been up since 4am but I am 2 hours ahead as I am in Altinkum/Turkey
Good news coming our way
Not the only one!!!
I can't believe I'm the only one that's so excited that I can't sleep.
It is marked for professional use / non public use which is why is can only bought in the packs. This is a way around the rules. So it can be used but not readily accessible by the public as lots of insurances and public liability needs to kick in.
Looks like we could be on for multiple amounts of good news tomorrow; approval, Avacta link, Antibody test pricing (£475 for 25) etc. I can’t help thinking it would be better to release each of these as separate rns’s over a few days if this is possible, as opposed to putting it all into one mega RNS. I reckon sp would be higher if news is drip fed over a few RNs to build momentum. Either way I’m sure we’ll past £1 in a weeks time
Not sure MHRA has approved test. It is CE marked for professional use. I could be wrong.
The abc test has already received MHRA approval we are only waiting for approval for self testing which is purely down to ease of use and the public being able to use the test by them selves. MHRA have fully approved the tests performance and is already approved for professional use so no worries there
199 out of 203 is 98.03%. Therefore 4 false negatives out of 203. This is as per the AbC-19 White Paper. Fingers crossed for MHRA approval!
So in this study they must have missed 4 cases only out of 203 , but if it was 4 out of 199 then it woudl have been below 98%.
Au , exactly
Validation results
In an evaluation of three validation batches, the test showed a sensitivity of 98.03% (95% confidence interval 95.03% to 99.46%) and specificity of 99.56% (95% confidence interval 98.40% to 99.95%).
These figures have been calculated following analysis of a total of 450 samples taken from individuals pre-September 2019 (negatives) and 203 patients who had symptoms of COVID19 or tested positive for COVID-19 PCR. and tested positive by a commercially available Antibody ELISA test (EuroImmunTM).
The test is already validated. MHRA was surely to ensure the device can be used by the public in the home environment?
Maths isn't my strong point but if the sample size is larger, wouldn't that effect % (eg 1 in 10, 9 in 100, 80 in 1000)?
https://www.sharebuyers.co.uk/shares/results-are-in-uk-rtcs-covid-19-test-shows-mhra-beating-specificity-and-140-day-antibody-detection/
“ Ulster university independent review showing 97.7% sensitivity & 100% specificity”
Results taken from here
Clinical sensitivity
Greater than 98% (with 95% confidence intervals of 96-100%) on specimens collected 20 days or more after the appearance of first symptoms.
Unsure how to read that.. Taken from MHRA requirements..?
Sensitivity is in the white paper isn’t it? Abi’s own validation.
Just because one study just drops below 98% does not matter as at least one study is > 98%.
In the same trial omega test beat Abott and Roche in different aspects of the test . So dont worry about the 97.7%
i checked a few weeks ago with Colin and asked him if any more sensitivity testing was needed and he said they had achieved the 98% and did not need any further sensitivity testing.
I thought that the sensitivity figure from the trial was 98.03%. Where has this 97.7% come from? Sounds like a problem if correct...
I thought we had already met the standards required & it was usability for home use that was the hurdle for MHRA approval.