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@magsy :)
clearly lmao
I am a genius
if a somewhat bumbling one :)
Clearly grims comment triggered all of this!
Good to see some progress.
@saint-tropez don't miss this one of mine...
DHSC updated again, now to "D: Ready to share / D3: Catalogue of Resources" and Tom's comment:
"Thanks for this David, the reviewers have looked over this earlier. They found this product promising and are keen for labs to be able to review this and consider its use. I will move the idea into our "catalogue of resources" page and we will share the link to this page via a bulletin to go out this Monday."
Very promising progress. But I still think GDR's focus is on India :-)
Ah right - Many Thanks for the clarification Technick,
I am a retired Aerospace Engineer/Manager, and our 'Gold Standard' was the 'Best Kit', manufactured to tight design tolerances, and used to check Production units against.
Wouldn’t hold your breath
No update tomorrow and I will be extremely disappointed.....
Hi BigAl, it was the first test to market so I suspect is the one people benchmark against, a gold standard is not necessarily the best one, its the one that's in place...
Hi Technick,
Many thanks for this information.
So is the 'Primer Design Test' considered to be the Gold Standard Test throughout UK and EU ?
Hi BigAl, it would have been a test organised by Genedrive, most likely in combination with an appropriate research organisation like one of the tropical disease centres. They would have run a study comparing Genedrive against another test, likely the Primer Design test. The data shows that Genedrive identified all the positive samples correctly, sensitivity, and also gave positive results for 1 or 2 samples that the other test had determined as negative, hence specificity was not 100%. This could be because the combative test was not as sensitive as Genedrive - I say that because the Genedrive test picks up 2 targets and the Novacyt test for example only picks up 1 so the Genedrive test is less likely to call false positives.
Hi Technick,
Someone asked this question on the BB, yesterday, but I did not see a reply-
When GDR was credited with the CE-IVD Mark, how would the Sensitivity 100%; Specificity 98.2 % have been assessed ? Was it a self certified Test by GDR ?
CE Marking is required for all in vitro diagnostic (IVD) devices sold in Europe. CE Marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC) and that the device may be legally commercialized in the EU.
There are four classes of IVDs:
General IVD (Self-Certified)
Self-Testing IVD
List B IVD (Annex II)
List A IVD (Annex II)
Under the IVDR, there will be four risk-based classes — A, B, C, and D. Most self-testing IVDs will fall under Class C, and many IVDs currently classified as self-certified will be classified as higher risk.
It’s good to see the board having a new ‘carcass’ to get stuck into.....might stop the pack turning on each other & bring some harmony back to the savannah ;9)
#PeacePlantsPatience
Every clinical site that is now evaluating the Genedrive beads will be validating performance and Genedrive will use these validations to support its sales pitch I am sure. It won’t reduce the requirement for a country to test the performance, but it will add credibility and justification for a country to evaluate them for their use.
The benefits of the test are not only performance and storage, the massive one for me is the ability to use conventional PCR machines in combination with real-time qPCR machines to ramp up throughput efficiencies and cut costs in terms of capital equipment. There are approx 100x more standard PCR machines out there compared to real-time qPCR machines and they are 10x less costly. Hence a lab that can set up multiple standard PCR machines to feed a single real-time machine and save a lot of money and set up more facilities and increase throughput. For Asia and Africa this could be a really important USP in my view and really sets the Genedrive test apart from all of the others.
For their qPCR beads it’s a wave through process though PHE will want to verify performance. For the LAMP test it’s a new IVD submission. I’m not sure LAMP gives any advantage over Genedrives qPCR beads to be honest, I don’t get the USP for that other than funding opportunities.
@saint-tropez I posted about the crowdicity link regarding the DHSC submission at 11:17am yesterday, you had all day to top up... ;-)
And another
https://testingmethods.crowdicity.com/post/3167180
Thanks for sharing, this is getting interesting indeed.
https://testingmethods.crowdicity.com/post/3237330
Not sure if this has been posted .....
High Throughput SARS-CoV-2 PCR beads - Faster end to end testing, no reagent prep, high throughput stability
by
David Budd
David Budd
| 2 months ago | in Increasing end to end efficiency and speed of testing
C: Further assessment
Additional information
We have developed and manufactured a proprietary 1-step 96 well SARS-CoV-2 test. The Genedrive 96 SARS-CoV-2 test is presented as a fully complete, lyophilised PCR bead, arrayed across the wells of 96 well plate (high and low profile for various RT-PCR platforms), room temperature stable and suitable for high throughput workflows. There is no reagent preparation in the laboratory - saving all the reagent preparation time and personnel. This is a proprietary UK developed and manufactured product.
The test targets the E and N genes, has an internal RNA target assay control and an endogenous human RNA control in each of the 96 reactions. The product does not require refrigeration for storage.
Key efficiency improvements are:
1. There is no reagent preparation by the technicians in the lab, significantly saving time and labour, and reducing chances of test preparation error or variance.
2. The test available as an endpoint-PCR so it could be performed on a standard thermocycler, with just the last 10 minute reading phase done on an RT-PCR platform. This drastically reduces the need for RT-PCR equipment, and you can increase laboratory throughput with standard, comparatively less expensive PCR machines.
3. The test is UK manufactured and already established in facilities at high scale, starting at 10000 test beads per hour. Because a production batch of beads comes from a single preparation of liquid reagent, the tests are identical in concentration and composition of active ingredients across a 10000-100000+ test batch. There is no test variation, loss of stability, or variation from one testing site to another.
4. The beads are room temperature stable, supporting the longer term exposure required in high throughput workflows.
https://genedrive.com/assays/in-development-genedrive-96-sars-cov-2.php
Have you validated this method, if so, how and what were the results of the validation?
CE marking targeted w/c 18 May for full data set, but development performance sensitivity is at 5-10 copies of target per reaction. Further data with be available at the time of CE marking. We can share preliminary data with DHSC but we are not yet able to publish more details in this forum,
How quickly could this be deployed and what are the dependencies?
Targeting CE marked w/c 18 May, and available for manufacture and distribution thereafter. Potential volume dependencies on supply chain. Attached a photo showing the bead production in process.
What is the likely production volume??
Manufacturing capacity to several million t
very interesting.
lets see what tomorrow holds
maybe bench and punter get married
:)
no offense to either of them intended.
or anyone else.
the text of this message is not intended to ramp or deramp the share price or in fact have any other effect other than maybe make someone smile slightly
god I need more coffee
@ Grim YAY!!!! I can sleep now.
@ Safy, apprecaited.
Grim,
Today has been an eventful day.
First Madhav phones Dr Kanav directly and now this, and me and Phil (think it’s Phil) got replies from Walbrook.
Keep up the good work.
don't give up
ST
Relax mate, honestly. We are not laughing at the fact we think it’s fake. Calm down, read Grims reply to me. He totally understood it. He’s chuckling to himself too.
The laugh is that grim had the balls to do what he did, and he kept his name as GrimShady on his profile. Kudos where it’s due.
Great detective work Grim.
So, Grim is Mike Potten? If not, I give up.
It doesn’t mean anything other than dialogue between Tom and DB is ongoing, and that DB has provided some information to Tom.
Tom doesn’t give any specifics or indications about what DB has provided. So for me it’s just a follow up Thanks for now. It’s BAU for both Tom and DB.
It would be stupid if DB didn’t supply the information they requested all those weeks ago.
There are no indications of sales. Tom must have this type of conversation with lots of companies everyday.
Unless I’ve missed something and someone can highlight where they discuss sales?
Hype,
So the original conversation is for all to see right. It not new news. It’s actually over a month old.
However Grim asked for an update to that conversation. Click on the grey reply box. And Tom has replied to him thanking him, probably without realising Grim isn’t DB.
That’s how I see it.
@ST - yes, I've been reviewing his Twitter. I still can't see the posts in Twitter where he's corresponding with DB, only the chat on testingmethods.com which I pointed to at 23:00 this evening. Getting late, I know, brain defunct.