Member Info for RNmyS

seesh, not having much luck with that link huh

https://bioservuk.com/product/avacta-affidx-sars-cov-2-antigen-lateral-flow-test/

If Innova is one of the tests mentioned in the RNS picking up either 50% or 0% of the Delta cases, how can the UKGov justify the use case now regardless of what they've got in stock? At a minimum, if Innova is one of those tests, this would call into question any consideration of extending their EUA any further.

Agreed MrA, you would. Her anti LFT narrative appears quite narrowminded considering the alternatives, which she should be familiar with based on her stance on LFTs in general (and mass tagging of her articles with "#ODX, #AVCT" on Twitter/ emails from investors here). I presume, based on the citing of Deeks in her work, that she does not support the use of LFTs for asymptomatic testing.

Sonia Elijah is quite a frustrating lady, she's clearly well read on Innova but fails to explore or state the alternatives (Mologic, Avacta etc). She's seems keen to chase a scandal, however, will not give any time to, for example, the decision of Mologic to sue the government for stonewalling their validation. This confuses me as it's partly connected to the Innova scandal via PD.

Unfortunately it seems she falls into the, all LFTs are bad, camp and thus her stories and subsequent coverage are a real double edged sword.

Hughes certainly aren't fans of Innova, from their website:

"Our test is a true nostril swab test and has only ever been designed as such, other tests will try to modify their test to include the nostril swab, but have do not have the clinical evidence to support that adjustment. Innova has claimed their test can be performed on the nostril wall despite being a nasopharyngeal test and as evidenced, you get the result of 40-50% accuracy in both Birmingham and Liverpool. Healgen are another provider that are trying to claim that their test can be done in the nostril however have no clinical reports done with this swab mechanism which will incur significant inaccuracies."

https://www.hugheshealthcaretests.com/product/rapid-antigen-test-kit-individual/

@.breath, your question is moot. Which tests are available for home use? None. The likelihood is that Avacta, and Mologic, will be the first LFTs to receive their CE marking for home use and until then we're stuck with whatever the NHS is packaging via the EUA.

As a new poster I highly recommend you search before asking questions which could be perceived as deramping nonsense.

I'll take that as a yes, print only

Can anyone get hold of the full story, is it print only?

Here's a screengrab of the article: https://ibb.co/f8NsCfh

Did he not just say partially validated (I know that differs from the slide) for the Delta variant though?

Interesting study highlighting what most already know, worth a read though (Published 31st May):
https://www.journalofinfection.com/article/S0163-4453(21)00265-6/fulltext

Highlights:

"In light of our findings that more than half of individuals with positive PCR test results are unlikely to have been infectious, RT-PCR test positivity should not be taken as an accurate measure of infectious SARS-CoV-2 incidence."

"Asymptomatic individuals with positive RT-PCR test results have higher Ct values and a lower probability of being infectious than symptomatic individuals with positive results."

"Although Ct values have been shown to be inversely associated with viral load and infectivity, there is no international standardization across laboratories, rendering problematic the interpretation of RT-PCR tests when used as a tool for mass screening."

This article supports the views of Dr Smith which he made clear during the last investor presentation: https://youtu.be/QKc7VuKzP1Y?t=386 (6:35: "overview vs PCR", 9:20: "how to measure infectiousness").

Great points TEMPLAR, thanks for sharing

Thanks Mr Adventurous, a couple of silly errors from me, I'll make some adjustments to my contribution and reshare "shortly"...

I've rejigged the final part, use or discard as you wish:

In bending the rules for Innova, the Government has failed to support the UK based diagnostics industry and appears to be holding up the development and validation of UK made lateral flow antigen tests. This can be evidenced by the actions of Mologic, a Beford-based diagnostics company, who have taken steps to launch legal proceedings against the Government for "stonewalling" the validation of their test 12. Furthermore, the government is also facing legal action from the Anglo-French company Novacyt for breaching their PCR testing contract with the DHSC (source) and are also in a pay dispute with the test manufacturer Abbingdon Health (source).

This is significant as our government claimed their top priority was and is the procurement of a sovereign test and supply chain, along with the support of the UK diagnostics industry. However, they are now being publicly ousted by the very industry they claimed to be supporting while continuing to ignore British innovation.

In the UK we have accurate lateral flow antigen tests. Both Mologic Ltd, alongside Whetherby-based Avacta Life Sciences have developed highly accurate, near-perfect tests which are far superior to the current NHS boxed, FDA banned, Innova test.

Mologic = Specificity 100%, Sensitivity 96.4%10
Avacta AffiDX = Specificity 99% and Sensitivity 100% 11

While these test numbers are impressive, the validation issues at Porton Down speak for themselves. As I noted, Mologic are now seeking legal action for stonewalling and Avacta have now warned their shareholders that Porton Down's procedures may affect the company's chances of winning any UK governmental contract 13.

This certainly is a scandal involving billions of UK taxpayer pounds. I implore you to look further into this story and give it the attention it deserves.

Taking a read now, but just remember, there is a good chance these people know nothing of this situation so it's important to keep the messaging as clear and simple as possible.

gje, as per the last Investor presentation, it was noted that GAD were already producing commercial batches for multiple verification and validation studies. I'm sure if a larger study is required, AVCT will be able to provide the data at very short notice.

If Innova cut and ran, it would be an issue for the supply of the tests as Innova hold the exclusive distribution rights... That being said, as of the 14th June, we have heard from an Innova spokesperson as per the Mologic Telegraph article:

https://www.telegraph.co.uk/business/2021/06/14/covid-test-maker-mologic-set-sue-government-stonewalling/

"A spokesman for Innova said: "Innova is committed in making the most equitable test with the highest quality and none of the inspectional observations in the FDA letter concern the performance of the test. The Innova rapid antigen test has been widely used and analysed with data from the largest mass testing program out of the UK.

"There is absolutely no link between the FDA’s letter regarding the process for authorisation in the US and the Innova products in the UK. We have robust data proving the quality of the product in many other jurisdictions with the largest data set from the UK.""

As I stated in my original post on the deletion of their YouTube and status of their website, Innova are deploying crisis communication tactics, making themselves scarce online while the spotlight is one them. They're certainly not gone, for now at least.

Unless Sisu, the Innova EUA gets extended once again... "Tests currently supplied to the NHS under DHSC procurement will be exempted in recognition of prior equivalent assessment."

Gave me a chuckle there Timster