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Thx to whoever found the Ulster self test report! Was that GPback? So we are being recommended as the no.1 antibody self test. 97.7% sensitivity and 100% specificity. 20 weeks detection of antibodies- much better than other tests, a big change in recognising immunity (most reports previously suggested antibodies waned after 3-4 months). So maybe it's just that the tests weren't sensitive enough to show antibodies? Just keeps exceeding expectations. Not that I can be accused of having low expectations;) but I am pretty pleased to read that. Everything getting lined up- perfect!
It is known the MHRA requires a specificity of greater than 98% for rapid antibody tests which adds weight to the likelihood of Omega Diagnostics and the UK RTC receiving the approval needed for home-use of the antibody test. However, with 97.7% sensitivity the question mark remains if it will meet the adjacent sensitivity MHRA guidelines that are also greater than 98%.
Could this be why we haven’t had MHRA update?
I thought we had already met the standards required & it was usability for home use that was the hurdle for MHRA approval.
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 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.
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%
Sensitivity is in the white paper isn’t it? Abi’s own validation.
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..?
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
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)?
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?
Au , exactly
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%.
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!
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
Not sure MHRA has approved test. It is CE marked for professional use. I could be wrong.
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
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.
I can't believe I'm the only one that's so excited that I can't sleep.
Not the only one!!!
Been up since 4am but I am 2 hours ahead as I am in Altinkum/Turkey
Good news coming our way
Been up since 4 am wales time , am I that excited for news here ?
We will open higher than 100p imho
Get ready to fasten your seat belts, we are about to take off :)
"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.