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Ndn: From the 22 Apr Presentation Q&A
"Practically, the lateral flow test performance would be evaluated with the new Affimer reagent to ensure that analytical performance in the laboratory was not affected. We anticipate that this would take a few weeks following the generation of the new Affimer reagent. The new test would then need to be evaluated in the clinic to confirm the clinical sensitivity and specificity which again would take a few weeks. Since this would be a new test from a legal perspective a new self-declaration of conformity would need to be made to affix the CE mark to the product. Our experience of new variants thus far suggests that we will not need to do this very often if at all."
If we are the gov test then any new virant analysis would be fast tracked by the gov. Im sure we would be given priority over samples/resources. Right now, we just need to get the confirmation based on everything as is.
"We will continue to monitor the performance of the Affimer reagents with future dominant variants as they become available to us. Since the Affimer reagents we use in Avacta’s range of SARS-CoV-2 tests do not bind in the region of the spike protein where the dominant mutations appear, we do not anticipate that the performance of the tests will be affected."
I read this as meaning that variants may not be an issue. Getting samples to test should become easier as the Indian variant spreads.
Onwards Avacta.
If they were to change the structure of the affimer they would have to go through safety and effectiveness testing and clinical trials once again which wouldnt be favourable right now. By far the best option is to ensure that the mutation hasn't altered the binding site of the affimer on the S protein although it may take some time to get access to samples.
And I think AS has already stated ce and cv would not be required
Co, if avct is integrated into the DHSC then the process from identification to tweaking will be rapid.
It won’t be that fast though in practice. Access to the variants or samples of their respective spike proteins to work with in the lab can take many weeks after the DNA has been sequenced and mutations identified. Look how long it has taken to confirm AffiDx works with the SA variant since we have known about it. And then if we do have to change the test, sure the architecture won’t need to be altered, but CV and CE marking would need to be rerun for the updated design. Of course, the same restrictions apply to all antigen test makers, and others don’t have the benefits of working with Affimers once they do get their hands on the virus variants.
Obviously better all round if the sensitivity holds up to the different strains as expected.
I hope the tender included a question enquiring how the bidder could ensure that their LFT could detect future variants inclusive of timeline to adapt. Responses would be interesting.
Ndn, it is likely that AFFIDX will detect as the spike protein is not mutating in the area the Affimer detects however even if it could not detect Avacta will just brew an exact match in as little as 4 weeks (gerry b from Deepverge stated that Avacta could change the brew in as little as a week)
I just read that comment on the BBC
This variant is now set to be the dominant variant in the UK as is thought to be significantly more transmissible.
Avacta will definitely be testing Affidx detects it.
With (currently) such low prevelance of the Indian variant it is worrying that already
Five people who have had a single jab have been hospitalised with the Indian variant in Bolton, and one who had received both.
This variant is now set to be the dominant variant in the UK as is thought to be significantly more transmissible.
Who can the government rely on to rapidly scale LFTs for the detection of such variants?