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Templar, when I initially saw that, I was under the impression that it was fake. Turned out to be true.
"And yes, we can confirm delivery of new UK Government-loaned equipment.
These are, after all, *very* busy times as we prepare our Alva HQ for the production of a government-selected lateral flow test."
"It's legit,I'm the haulier. I have just delivered a wrapping machine for covid flow tests to #ODX on one of my trucks."
Copy of Delivery Receipt
"a wrapping machine for covid flow tests".
That would be interesting.
Epping, you are either very immature or part of the trolling deramper gang. You ALWAYS respond and keep the trolling going. Why do you do that? Just leave it will you, on all threads.
Back on topic...
The ODX tweet was in response to this on 26 July:
What was delivered was described as "a wrapping machine for covid flow tests".
If this was indeed what was delivered then I'd posit that this machine is for a separate line; with many of the LFTs having been manufactured (what else could they have been doing all this time ffs!) and now the printing now sorted and done (wouldn't that be great!), the LFTs and all the other bits and bobs can be loaded into their separate silos and merged by this wrapping machine. ...Wonder if they've got a spare boxer as well?
"Porton Down is not there, but also I don't see any exemptions within the process for tests that have previously been passed by PD, meaning that ALL tests will now be required to meet the desired/acceptable criteria."
Thanks Mr A.
Epping mate, how are you doing? How are the calluses on your knuckles?
just caught your classic “nobody listens to you” after reading my post lmfao
You’re brilliant comedic value!
I would suggest the reason PD requirements have been dropped is they are legally untenable.
Mologic were taking them to court and Govt presumably accepts they would win
Dunno if BG et al has said they’re dropping it or ploughing on
How many times…
As many have said already, this is great news for Avacta, but only of they get those clinical validation numbers up to the minimum required. If they don't, they don't qualify and will be rejected.
Investor Meeting recording now available:
Still in talks with UK Government:
AS - "we are still in the process and discussions with DHSC and Porton down and I will update the market as soon as material news develops"
He also says “other capacity not just relying on government equipment”, going on with the UK government." which clearly confirms that they are ALREADY using UK governnent equipment.
No further Porton Down Testing...
No third party Validation laboratory ...
No frozen samples ...
Avacta just need to obtain a few more Clinical Test results (which they are already working on) and they can apply with the existing Clinical Test Data obtained in Spain
Private Testing Desktop Review (stage 2) Operating Process for SARS-CoV-2 Tests
Published 28th July 2021
This guidance outlines how the government will undertake the desktop review of COVID-19 viral detection tests submitted for assessment.
Overview of the Process
This review is a systematic assessment of the evidence submitted by a supplier against a minimum required data set.
If so surely this is massive good news for Avacta
Can someone confirm please?
The new validation process looks like a paper exercise where clinical test data is reviewed by DHSA?
- So no further testing by DHSA - just validation of provided Clinical Test Data?
- So much quicker and no use of "Frozen" samples?
Either way, we ARE heading to £2+ again in the coming weeks.
Should be a good day tomorrow ahead of Bioserve (Calibre) Affidx sales starting on Monday.
Let's hope AVCT RNS the start of sales on Monday.
Although I wouldn't be at all surprised if its ignored as per previous non existent PR.
The most important part by far is:
"DHSC will prioritise certain applications where necessary, for example if it’s in the interests of public health."
So I fully expect AVCT to receive immediate/priority approval, especially as the ODX tweet from 3 days ago said they "confirm delivery of new UK Government-loaned equipment.These are, after all, *very* busy times as we prepare our Alva HQ for the production of a government-selected lateral flow test."
I am confident the government will choose the AVCT test. Its the most accurate test and Al has repeatedly said he is still talks with the Government and we know that an ODX scientist confirmed in January that he was working on AVCT test.
Combined with the official AVCT distributor Affidx sales start date being this Monday, 02 Aug, and the start of AVA6000 Cancer first dosing due in "late July" we are in for an exciting couple of weeks and £2+ again.
22 Jul 21
Received email from Bioserve (Calibre),official AVCT distributor, that they begin AVCT Affidx sales on 02 Aug 21.
Omega (ODX) twitter
26 Jul 21
"And yes, we can confirm delivery of new UK Government-loaned equipment.These are, after all, *very* busy times as we prepare our Alva HQ for the production of a government-selected lateral flow test."
28 JUL 21
"DHSC aim to have the results of the review within 20 working days, but this may take longer if there’s a high volume of applications. DHSC will prioritise certain applications where necessary, for example if it’s in the interests of public health."
My holiday - booked back in January! - starts with a flight out in September to Spain (which, as far as I can make out only require double jabs) and return in October and I've been praying for Avacta's AN LFT to be accepted as proof of Covid-free for that return.
In my view, this has been redesigned based in complaints from Avacta and to support Avacta.
As we know, Avacta have been carrying out more studies - to meet the >=100 and >=150 tests level and also to, hopefully, increase the specificity figure following the single miss in the Spanish study - and, we believe, have been carrying out self-test studies through Medusa. One would like to think that these studies have gone very well, the data has been shown to PHE/DHSC together with the corresponding Ct values, and that this has influenced the drawing up of the new, much tighter and more tightly defined criteria.
(Apologies to Ophidian for the misspelling - going from memory)
Icecool, hitting the highest level is categorised as clinical - so I’m very hopeful that this is at last formal acknowledgment that the best quality LFD can be used as a PCR replacement. Airports seem like the obvious candidate so fingers crossed
Ignore the below, the classification for the viral loads are fine!! Read it incorrectly apologies.
I’m a little annoyed that the range for high viral load is <25 instead of <20 but if no exemptions are in place and everyone is on an even playing field this should be good for Avacta. I’m now hoping they switch from PCR to LFT for travel!! With this new framework but that would be sensible and I don’t trust the government so we will just need to wait.
Didn't want this to get lost at the bottom of a thread that NDN and it's respondants have been all over. If any of the trolls post here, maybe just ignore them and not respond, eh?
re the 'Guidance: COVID-19 test approval: how to apply' document ( https://www.gov.uk/guidance/covid-19-test-approval-how-to-apply, Published 28 July 2021) that Ophidean posted today...
Porton Down is not there, but also I don't see any exemptions within the process for tests that have previously been passed by PD, meaning that ALL tests will now be required to meet the desired/acceptable criteria. If so, then this is VERY positive news for Avacta! Also good news is that Ct value ranges covering high, medium and low amounts of virus are defined and will need to be included in clinical validation studies.
The 'Guidance: COVID-19 Test Approval' links to these two [Word] documents:
1. Test performance guidance: 'Private Testing Desktop Review (stage 2) Operating Process for SARS-CoV-2 Tests' ( https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1005924/Test_performance_guidance.odt, Published 28th July 2021)
All very interesting. Plus it has a link to 'Guidance: Target Product Profile: Laboratory-Based SARS-CoV-2 Viral Detection tests' (https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/target-product-profile-laboratory-based-sars-cov-2-viral-detection-tests, Updated 17 June 2021) which states:
"The comparison should consider the effect of treatment or storage on virus material prior to use and the impact this may have had on the ability of that assay to detect inactivated virus/degraded RNA. Sample must be processed in accordance with the instructions for use." - essentially saying that manufacturers IFU should be used, not the PD spiked frozen saliva samples method.
2. Technologies Validation Group guidance: 'Technologies Validation Group Guidance for the use of tests to detect COVID-19' ( https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1005922/TVG_test_threshold_guidance.odt, Published 28th July 2021)
All very interesting. Plus it includes this passage:
"Cycle Threshold (Ct)
During the test validation process, the diagnostic sensitivity is carefully assessed by ensuring there is fair representation of samples with high, medium and low amounts of virus in these. Selection of samples for this exercise is based on their real-time, reverse transcriptase PCR result known as a Ct (Cycle Threshold) value, where samples with Ct<25 are considered to have a high amount of virus, those with Ct>25<30 are considered to have a medium amount of virus, and those with Ct>30 are considered to have a low amount of virus." - meaning that the sensitivity data will now be tied to defined Ct values."