Member Info for Trickymatters

Talking to yourself again Guy?

For Dave, who needs help with reading and comprehension.

'Therefore, it is highly recommended to carry out additional validation of the clinical performance of tests for COVID-19 by comparison with a reference method in a sufficiently large number of target population subjects before
introducing the devices into the clinical routine. Scientific peer-reviewed results for the clinical validation of commercial COVID-19 tests are highly recommended before they can be safely and reliably used for medical or public health decision making. Validation refers to confirmation that the test achieves the performance levels specified by the manufacturer.
Such studies are being done by competent authorities and reference laboratories in Member States. There are obvious benefits of sharing the results of those validations and organising centralised validation studies to make the most efficient use of resources. Fast-track clinical validation studies of rapid diagnostic tests for COVID-19 by hospital laboratories are ongoing in several EU Member States. Cooperation would also be beneficial at international level where the same tests are used in different jurisdictions. Both the WHO and FIND are
currently working on validation studies of different devices.
Scarcity of reference methods and materials poses difficulties for these validation studies, and also for the evaluation of device performance by manufacturers. The Commission’s Joint Research Centre has recently developed a positive control material for RT-PCR tests which is available to laboratories in Europe. Seroconversion panels and positive sample panels are examples of further materials that are needed. Another issue currently is the lack of publicly
available comparator data, which makes it difficult to compare the performance of devices.
External quality assessment schemes could be one way to generate such data. The ECDC and the WHO are already in process of organising an external quality
assessment scheme for RT-PCR tests.

6. Actions undertaken by Commission so far
The Commission has already taken the following steps as regards market access and performance of devices:
? Facilitating continuous exchange of information between competent authorities for invitro diagnostics in the framework of the dedicated subgroup of the Medical Device Coordination Group. This includes regulatory exchanges on device conformity, availability and reliability, maintaining an inventory of devices and sharing information on national actions, covering also national derogations issued by Member States and justifications for them.

16 Note: The WHO’s emergency use assessment and listing programme (see
https://www.who.int/diagnostics_laboratory/EUL/en/) has received 30 applications and finalised'

I'm not trading insults with you Dave. You're too thick for words.

Guy, Dave, Dr Aim,
Have you managed to finish reading a document that is more than one page yet?
Don't bother apologising.
Everyone needs to get their head around the fact that there's no way that the EU are just going to allow a CE mark to pass for validation of tests for sale across the EU. A CE mark is a quality control certificate. Many professional firms are set up to provide a CE mark. The latest on this is that Macron is now calling for a standard approach for approved tests to fit in with the covid certification scheme. Hasn't happened yet. But it will because they want the latter to be in place by July 1st.
I am buying tomorrow.
GLA.

Who are you calling a clown Guy Incognito and Dave McPrat?
https://ec.europa.eu/info/sites/default/files/testing_kits_communication.pdf
CE mark is merely the first stage. I must admit I have wondered why people have kept saying it has EU approval. It needs WHO, ECDC or member approvals including independent validation studies. Anyone can get a CE mark from a willing partner organisation. There are a number of FIND studies going on to validate various tests right now so who knows. But that won't cut it I'm sorry to say.
Back to school Guy and Dave.

Rb08, is it on the EU list of approved suppliers for covid certification? Don't think it is. Be very happy to be wrong.

We haven't got full EU approval Guy. Don't lie. Plenty of investors will call you out. It's only 1 EU country who have approved. We will get there.

Reported it in real time on the ODX board. Restrictions confirmed to July 19th and some until August. All subject to review. Public asked to get their vaccinations and continue taking regular lfts and a PCR if you test positive. The virus will continue to mutate and challenge us. The virus is a global pandemic and it won't go until the world is safe. But we are working to make things as close to normal as possible.
Testing will be here for a few years imho from that vignette.

From Nicola Sturgeon regarding going forward. Still encouraging working from home. New variants will continue to pose challenges to our progress. It will not be completely over until it is over world over. From 19th July life should feel much more normal. Key asks: vaccination for all; secondly please test yourself regularly with lfts and a PCR if you test positive... TV have taken her off now.

Hold or Buy. Sturgeon says the link between cases and deaths and hospitalisations is now much weaker. They are also putting back restrictions to mid July. Aim is now to suppress virus to a level we can live with. Expect to remove legal restrictions on social distance. Might get on my pc now in case she mentions tests. Laters.

Not much logic in that statement there Gloria.

Nobody knows except GDR. But you are right for once in your life Guy, they did say the end of Q2. So next week is a real possibility. And, in terms of our experience as adults who take responsibility for some uncertainty, we know plans and reality are not always perfectly aligned, within the next few weeks is also a possibility. And tomorrow or this afternoon is a possibility. Lol.

In the House of Commons from midday. They are deferring the Events research programme report. Been watching. They are onto a bill now but you can get it on catch up parliamentary TV. Clearly good news. They got some stick from Tory backbenchers that they aren't releasing it yet. They are concerned about the Delta variant but they've said they will publish before July 19th.
Hitting confidence across all covid shares/mms taking advantage because there's very high buying. Hope it's us buying not the mms.

Guy, I haven't said that. That's what you are suggesting I have said. I will put money on £1.50 on FDA approval. It will come. Sorry I haven't got a crystal ball. It could come next week. Or tomorrow. Or the week after. Grown ups understand this.

Coldplay, what? I can't understand what you are saying? Who is printing what? What does your third sentence even mean?

My confidence is based on my research and staying on top of the news. Watching the debate right now in the HoC. They are clearly deferring the report because it is good news on the trials but they are unhappy that the Delta variant is still quite high. They will release the report before July 19th and it will be all systems go. Look at what Dr Susan Hopkins said on Marr and what Han**** is saying every day. Testing will replace isolation and PCR tests will be required for travel.
We could easily see the POC design RNS here before the end of June and FDA approval to boot for the GDR testing kit. This will be a bad dream and we'll be looking at an sp of £1.50 -2.00 as soon as those 2 bits of news drops.

The government events research programme was due to report today. They have deferred the release of the report. Hitting confidence across all covid shares. A lot of kickback in the House of Commons. Seems that the report will be positive. But now they are doing another trial.
Still appear to be determined to open up on July 19th. Travel feels ambiguous. Knocking confidence for now. It will come good. I am going to buy here today again. Was prevarication between GDR and ODX for a decent top up. Will reduce my average more here. Both will do very well.

Well done Big Jock! That will pack a punch for sure.

Hasn't digested the news that both Matt Han**** and Dr Susan Hopkins are trying to communicate with their pr this week. Others have been floating the same thing last week. Living with covid means more of us- anyone at all socially active, getting the NHS app and taking tests every day for a week if someone gets covid anywhere we are, when we're out. It means taking tests if you want a holiday. Taking tests when you go into the office or the gym...you get my drift. We are back to the counter-intuitive thing where people feel it's over. It ain't over. It's always going to be in our lives. The new normal will be regular testing.
Yet another trial is due to report on the implications of tests over isolation. They have decided already. That's the way it will play out. Not before bloody time.

JAdam, you aren't 'we'. You have told us all about 30 times that you sold up. **** off. You complete knob.