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That'll be Hand***'s sister's new company then.
Wonder where all this leaves Porton Down?...disbanded?
Presumably, the winning bidder of the Laboratory Test Validation Services tender will be doing the new evaluations.
I hope all existing LFTs will be tested for their ability to detect the Indian /delta variant.
however note also the paragraph in the government guidance
"The new legislation will help consumers who choose to use private tests by giving the clear comparable information so THEY can confidently choose a test in a RAPIDLY EXPANDING MARKET" (capitals mine)
Agreed PL.
Sleepy, reads to me that it’s for private companies using tests for track and trace, exempting quarantine etc. It’s the equivalent of the current list of PCR test providers for travel, but within guided standards so that if you’re not approved you can’t be used for any official testing purpose
and the whole thrust of the new materials is to emphasise how important the self test lft industry is going to be in the UK in years to come
The spin in the new materials is that all private covid tests will have to meet a revised set of standards "in line with those used by the government".
Which makes it even more obvious that they would exempt the general category of tests ordered (and no doubt to be ordered) by them (because the governments premise is that the private industry is full of cowboys selling tests that don't conform to the governments high standards ha ha)
and in any event the point about the proposed legislation is that it is to do with the private testing market surely.
Correct me if I am wrong but surely it has no bearing at all on who may or may not be the governments sovereign test ( or whatever the term is nowadays
I don't share the qualms of those who are reading something sinister (as opposed to stupid) into the provision exempting current Government tests from the new qualification standards.
Innova imo are gone. I would be surprised if their web site or their you tube vids return. If the government were still holding a candle for them they could have extended the EUA for more than 10 weeks.
The exemption clause imo would make total sense to a civil servant. It's all to do with (in a general sense ) preserving continuity. Also perhaps to preserve Government blushes if they have to actively ban one of their tests (as opposed to just not continuing with it)
The new provisions however are for the purpose of widening the pool of tests to encourage good ones into the fold.
We may even find that Al has been consulted in framing them?
Might yet be, given their desired criteria. Picture the scene at airports.. shoes off, belt off, laptop in separate tray, wipe your backside. Maybe that’s where the sniffer dogs get involved
Personally I was hoping the Chinese anal swab was going to make a comeback as the best test , simply for the amusement factor of watching people fiddling around with their trousers whilst waiting to get into a sporting event or on an airplane .
What's the chances that, come Autumn the MHRA will just change the instructions for use of the NHS test to spitting directly on the LFT, wait ten minutes with 99.9% sensitivity assured?
@Icecool. Where are you seeing this 'Step 4:' stuff etc?
Do you have a document link?
Cheers
Few documents updated on website think below is interesting, with AVCT two studies assume it’s enough for essential.
Step 4: product performance
Minimum evidence to support performance claim
Desirable
150 clinical ‘positive’; 250 clinical ‘negative’ as determined by a comparator laboratory RT-PCR
Essential
100 clinical ‘positive’ and 150 clinical ‘negative’ as determined by a comparator laboratory RT-PCR
The comparator method must meet the ‘desirable’ requirement of the MHRA laboratory based TPP for extracted nucleic acid techniques.
Clinical diagnosis or contrived samples are not acceptable comparator methods.
The performance results raw data (CT values or equivalent) is required in the supplementary evidence submitted via the portal to evidence that the dynamic range of the assay has been evaluated.
Actually, the most sensible approach here is to contact our local MP's and ask them to table an amendment. This is proposed govt legislation, so amendments can be made in Parliament. I suggest the best target for an amendment would be the removal (or modification) of the following clause, on the basis of non-level playing field, or such like. I'm going to put something together over the weekend. Democracy begins at home, and all that.
"Tests currently supplied to the NHS under DHSC procurement will be exempted in recognition of prior equivalent assessment."
Yes, Will, I said that without a tremendous amount of conviction :-)
But, if there was ever a case that the Good Law Project should take up, this is it.
I mean, they take up the ABDX case, involving a few million quid expenditure.
We're talking a few billion in this case.
[Sample type - Desired - Method not requiring a swab (e.g. saliva, sputum, stool, breath sample)]
Can you imagine AS reading this, having changed direction 8 months ago, presumably at the governments behest.
He'll be going mental! Probably turn up at Downing Street one day with a sawn off shotgun tucked under his lab coat.
Yes, fukc this govt, let's get 'em out in Europe and totally embarrass this bunch of lying shysters.
It's just more hurdles that they can fail tests on as an excuse.
The last paragraph says it all.....
They will continue using Innova.
It's becoming clearer now the frustration big Al and the team have been facing dealing with this government and their hidden Agenda,they have done well to keep there composure and professionalism.
The whole situation stinks to high heaven.
"Innova back door by government"
[Tests currently supplied to the NHS under DHSC procurement will be exempted in recognition of prior equivalent assessment.]
There has to be grounds for legal challenge here.
There has been no equivalent assessment.
Innova has not been validated against AN sampling method.
Innova IFU states the test is suitable for symptomatic only.
The 'real world' sensitivity is very poor.
This is absolutely appalling. We need to organise a class action here urgently.
Innova back door by government
Last paragraph Notes to editors.
Producers of tests currently on the market will need to apply for validation by 1st September 2021 and have passed successfully by 31 October 2021 in order to continue selling tests past 31 October 2021. Tests currently supplied to the NHS under DHSC procurement will be exempted in recognition of prior equivalent assessment.
*if the govt aren’t using it
Yeah, I think that explains the extension to end of August, the next day they drop the EUA and let them sell under this legislation even though they’ve never established the performance of the test that’s in NHS boxes. Putting it all together it’s looking like innova until end of August and then a free market when the strongest should survive. If they’re still using frozen pigs then it’s time for the best of British to rule the waves around the world and forget the U.K.
Not sure what the govt equipment is for at this point, if the govt are using it, all good as we can take the top end of the range for private sales instead of the govt. All the above also explains the ongoing delays and frustration at the slow, ongoing dialogue. They’re constantly shifting the goal posts, this is just the latest. None of it makes any sense though. PresAl in the MHRA RNS suggested we’d support the U.K. and they’ve tested for the SA variant via PD so do they recognise the excellent performance or not.
Innova will also be ruled out by the new Target Profile they have published. Very easy for us to be sceptical as we have seen it all with Innova (sadly), but they won't go >97% for a green light test (desired). Will take some serious forgery for that to happen. Again I won't say it's impossible.
https://www.gov.uk/government/news/government-sets-out-laws-to-validate-accuracy-of-private-covid-19-tests
A little birdy told me AVCT go at 98%... P.S. the sensitivity level they desire is 99.9%. :-)