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Is still on the case, this was his reply to an email sent recently;
" I am currently trying to pull together evidence to illustrate the asymmetric process at PD and provide evidence of efficacy of the excluded UK domestic tests. I have applied for a Westminster Hall debate on this issue and have secured interest from official opposition."
A positive response and you can be sure he will deliver.
The Omicron variant is the problem and it certainly will be a problem with all the LFDs on the market. How many will now evaluate their tests on this news. Roche, Abbot and the likes will almost certainly have to react, the sensitivity of their tests in America is being questioned.
This is a Antibody problem not an Affimer problem, we now know there is a problem with potentially all the LFDs being used. Yet again the all the tests given exemption from the CTDA will be used with no priority given to evaluating their sensitivity to the Omicron variant. PD has plenty of live virus samples available if they wish to evaluate all the Chinese tests, lets see their reaction.
Personally I find no evidence to blame Avct and commend their honest approach. There is a solution, you would think by the reaction of the city parasites we were dead in the water.
The manufacturing process of the LFD employs Mologic architecture, not a straight forward TT as highlighted by the timescale to complete. imo.
Mologic state " Independent verified Cov-19 Technology combines all reagents in a Unique Design and integrates reporting of results."
In the long run the quality of the test will promote future LFD targets. ABDX will react on orders for tests and Quality will win in the end .
Many if not all the LFDs on the market using mAbs do not detect infectious presence with PCR Ct values 0ver 29 -30. This is now being observed as large scale testing results are compiled. A fact the Yanks are now acknowledging, cheaper tests require more frequent application reducing the price differential. AffiDX will do what all the rest need several attempts to achieve.
We will not produce the volumes of the second best LFDs however Avct will be recognised as a leader in the Diagnostic market imo. A job well done by the Avct team. Happy Days.
Certainly fits the when comparing the Roche LFD test results with Avct and the coal has FDA EUA
https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/2228
Roche test results as listed on EU LFD Database.
Sensitivity 89.6% at Ct <30 and 93.1% at Ct <27 Specificity 99.1%
Roche a multi billion pound company, renowned for its diagnostic products beaten hands down on Sensitivity by AffiDX.
The Yanks love a gold rush and there is no doubt they will be all over this. Gold Fever, could be our next LFD target!
Poirot, nice to remove the blinkers and reveal the true value of Avct, cheers.
Some really big hitters involved in PNT now ;
https://www.globenewswire.com/news-release/2021/06/30/2256054/0/en/POINT-Biopharma-Debuts-as-Publicly-Traded-Next-Generation-Radiotherapeutics-Company.html
Well done Mr Smith, exciting times ahead.
Surescreen according to a Comparative Performance test of 6 LFDs covered by the Lancet is crap.
https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(21)00143-9/fulltext
Therefore made in China makes sense, performance results in Fig 1 illustrate just how bad a test this is.
Innova beats its S&S results by a mile and that basically says it all.
A £20 million pound contract for this is a joke, or did PD manage to bump up these results in their Phase 3 field test evaluation?
The evidence confirming Affimers bind to the virus spike is overwhelming. PD are digging themselves into an even bigger hole if they refuse to listen to reason.
https://www.gla.ac.uk/researchinstitutes/iii/cvr/aboutus/
Video confirms the part they play in virus research.
The Centre of Virus Research evaluated the Affimers submitted by Avct and concluded they were excellent binders to the spike protein of the virus. A fact from the top European Research Centre with an open mind culture.
Avct stated ; " However in its evaluation PD used artificial samples not clinical samples. The artificial samples did not reflect the spike on the virus in relation to the actual virus itself. Avct generate Affimers which bind to the REAL virus spike protein, PD do not." Simples, what else is there to say on this subject. This discrimination by PD on LFDs targeting the spike protein needs to be shouted from the roof tops until common sense prevails.
Unbelievable how they can justify their stance on a flawed testing procedure, criminal in fact.
Ninkynonk are you a fellow Fifer, Neale Hanvey is my MP and will respond to constituents on his favourite subject. I have sent him the official EU document listed in their data base naming the LFD a HUA test.
https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/2426
The DHSC / PD has known since June this year ( date of receiving CE mark for PU ) their validation system for LFDs was flawed. Now 6 months later we await their second attempt in declaring the LFD is gold standard. They are completely incompetent or something is about to blow.
Keep up the good work and supply Mr Hanvey with the facts.
Results third rate according to the EU validation list;
https://ec.europa.eu/health/sites/default/files/preparedness_response/docs/covid-19_rat_common-list_en.pdf
page 37 , Roche clinical evaluation Sensitivity 89.6% & 93% at Ct < 30 /27 respectively.
Independent evaluation varies, one set quoted 81.2% at Ct <33 & 91.7% at Ct < 25.
Where this 95% Sensitivity comes from, who knows.
The FDA are happy , we are much better than this. I hope Mr Danaher is paying attention.
Just collected my HUA test from the chemist, FlowFlex.
Has EU HUA but not passed PD phase 3, we love Chinese tests evaluation process.
https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/outcome-of-the-evaluation-of-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens-lateral-flow-devices
How did they manage to get in on the act ????
https://www.bmj.com/content/372/bmj.n287/rr
Can fail according to this bmj article.
https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/covid-19-test-approval-step-2-process-for-desktop-review
gje306 the process above was updated in December the same date for the Evaluation process.
The Desk Top Review gives an ; OVERVIEW OF THE PROCESS.
" The DT review is a systematic assessment of the evidence submitted by a supplier against a minimum required data set. The purpose of this step is to prevent tests that are below the expected standards from progressing to a Technical Validation in a Laboratory."
The guidelines for the DT review is clearly defined above, a short list of the best LFDs will be selected using this protocol.
Next step Phase 2 and 3 of the Laboratory testing, then the Field Trials. That is my interpretation of the process ?
15th Dec ; "We are progressing with our application to the CTDA in order to put the AffiDx product on the market in the UK".
https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/protocol-for-evaluation-of-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens-lateral-flow-devices
AIM ; Current sample resources only allow a limited number of devices for full evaluation.
PROTOCOL ; Products on the basis of test results are considered to have a better chance of making the required standard to progress to large scale field testing.
PHASE 1 ; Desk Top Review, to identify tests which may perform with sufficient Sensitivity and very high Specificity.
PHASE 2 ; Futility Test.
PHASE 3 ; Supply 4000 tests, and carry out test on 1000 true negatives / 200 true positives.
Next stage of the process ; UKHSA / PSNC the Pharmacy negotiator will provide Pharmacies with 15 packages each containing a LFD/ PCR test spread over 3000 outlets. Purpose to initiate Mass Evaluation exercise (45,000 LFDS being evaluated ) over a 3-4 week period starting in December.
Conclusion ; imo the RNS statement declaring the process of CTDA is still on going suggests we are out there taking part in this mass evaluation process. Estimated completion date 3 -4 weeks.
Metatron are you implying I am dreaming all this up, try checking post on 13th Sept MY LOCAL MP NEALE HANVEY.
Always DYOR before making what now appears to be a very silly comment. Love it when it comes good, just like investing in a winner.
Neale Hanvey, my local MP who true his word raised the question on British LFDs not being used and the quality tests being ignored.
In Sept I raised this issue with him and several other points, the PD fiasco and how Avacta / Mologic were force to take their test to Spain for validation.
He replied days later, " I have reflected on your email and will look to put down some Parliamentary Questions to highlight the points you made."
Watched the video and his question was not answered, these clowns have no idea what is going on.
I will contact him again, this time asking why the Evaluation of LFD Tests / Desk Top Review is taking so long and if he is aware the most accurate LFD in this process is being ignored.
Here's why : https://eur-lex.europa.eu/eli/reg/2017/746/oj
War and Peace EU Regulations, only six Notified Bodies doing the work and not part of the EU clowns closed shop.
In the throws of a pandemic and in the interest of Public Health it takes around six months to complete a paper exercise.
If you are in the EU 3 months ( TV SUD - FlowFlex ) Germany.
FlowFlex were granted EUA in the EU whilst HUA was being sought, no such preferential treatment for a better test.
https://reliefweb.int/report/world/act-accelerator-strategic-plan-budget-october-2021-september-2022
Interesting read, for those who think the boat has sailed.
Para 3.2 Diagnostics.
Over the next 12 months the ACT Diagnostic pillar will support procurement of 988 million tests to advance testing rates in Low Income Countries / MICs.
Avct doing their part with GAD in manufacturing millions of LFDs for this market, great PR for the LFD.
Eventually a LFD with 100% S&S at < Ct 28 has to be recognised for what it is, the gold standard LFD.
NB ; LICs / MICs daily testing to be increased to 100 out of 100,000 of the population = 988 million tests
HICs 750 out of 100,000 is the ratio of daily testing, 7.5 times more, got a calculator. Quality sells in High Income Countries.
.
Ebbsandsflows, just had this sent to me.
Wetherby twinned with the UISTS, message sent by Big Hamish who lives in the Outer Hebrides. He wants to know the connection, after considerable thought came up with ITS US. Now believe that if you will, I never ever tell porkies, promise.
https://www.kethema.it/wp-content/uploads/2021/08/Dichiarazione-Conformita%CC%80-Flowflex-Self-Testing.pdf
An official copy, to be used as a reference only. No fakes allowed.