Member Info for RegulatorUK

"Proper Eeyore our kev. Only ever pops up for a good moan"

He's also a complete ass...

IGMC.

What will the board Cassandras and trolls read into this?

"Orders should start to be formally announced. Maybe even on Monday during the day...we will see."

I think we might not get orders announced until after Boris has laid out the plans (subject to any tweaks following the 'Daily Wail Pearl Clutcher' tests this weekend) on Monday evening - he won't want anything stealing his thunder. I think we might see details from Tuesday morning onwards.

"IWWTBOOTOTW?
Is this good?"

IWWTBOOTOTW = I Wouldn't Want To Be Out Of This Over The Weekend.

A phrase often inappropriately posted by rainbow chasers... but possibly very appropriate for ODX (and other LFT manufacturers) at the moment.

NT to sell on H&L...

"Good Morning Regulator. :) Hope your well Sir. Interesting couple of days before weekend I feel."

Morning guv'nor! As you say, an interesting couple of days before the weekend.... this may be a case when you really can say "IWWTBOOTOTW".

We can expect select details of the government's plans to unlock to be leaked to anointed client journalists over the weekend so that the 'Daily Wail Pearl Clutcher' response can be measured and the plans tweaked before they're formally announced next week. So Monday could also be fun...

"I don't have any links, but just saw on Sky News that some Asda stores are being supplied with LFTs.
Local authorities were not informed, which was the actual story."

Did it say whether it was antigen or antibody LFTs? No need for the local authority to know about antibody LFTs but good reasons for them to know about antigen LFT use (as they're the notifiable body for positive antigen tests).

Link's not working....

Give us a clue what was being said.

"Good Read. Thanks
Note that deeks was a reference lol"

It's the fact that Mina et al point out that Deeks et al misinterpreted data that raises a smile in particular from me.

What’s really nice about it is that it’s international scientists backing LFT use. Another two fingers up to Deeks et al.

“ Korda - look at the dates ffs man. What do they tell you? Or are you too busy looking at headlines only?”

Yep.... and the same link was posted on here yesterday.

You'll have to excuse me... other half has a late clinic today so I've got to walk the dog.

See y'all tomorrow!

"Isn't it more of a problem of vaccine supply though? Better a few larger centres than numerous smaller ones. Easier logistics etc."

Not really. There are established distribution networks in place anyway (it's how the 'flu vaccine is distributed every year).

A lot of this came down to the vaccine roll-out happening a bit too early (for political reasons), which has led to vaccine shortages and a mish-mash of vaccine delivery (I was supposed to have the Pfizer vaccine and had been sent the forms in advance to complete but when I turned up they'd had AZ delivered - which meant a whole different set of forms had to be completed). If they'd taken a bit longer to put the process in place things would have gone a lot more smoothly...

"My wife has to take a photo of it and upload to a site as well."

That'll be your third party validation.

One requirement of the updated TPP/design requirements for Covid tests is that the individual test and packaging must carry a QR code. The idea being in future tests issued can be matched to tests uploaded via a web-site/app.

"Pharmacies could do many hundreds a day and send out results 4 times a day by text? or if lower volume - just sit and wait"

What's been really disappointing is the failure, in large parts of the country, to use community pharmacies to roll out the Covid vaccine. They're actually really good at that sort of stuff - and have the systems necessary to record vaccination (as they do with the 'flu jab).

"They are about but you can't pop into a chemist and buy just the one for yourself as an example."

Sister-out-law is a teacher. She tests at home - but has to return the used test for validation.

"Hmm. Yes I recall all that I followed it closely obvs as we all did. I guess Joe Public must include all the care workers and NHS staff and university staff and students who are already using them? So are you saying there may be requirements for staff training and/or supervision as far as you know?"

As I said:

"Any antigen tests will need to be 'supervised' so that positive tests can be verified and reported appropriately. You may see some groups of people (e.g. healthcare professionals) being able to test themselves but, in the short term that won't apply to Joe Public."

Asymptomatic antigen testing is restricted to particular groups. At present it is classed as 'supervised' in that the test results are validated by a third party. How that is done varies depending on the setting e.g. my partner, an NHS hospital consultant, tests himself but the used test is submitted to his OH team for validation, whereas a friend of ours works in primary care and she is tested by someone else when arrives at work. Another friend is a social worker - he has to go to a testing hub twice a week.

It's worth noting that the GPhC guidance relates to professional POC or near-person (e.g. supervised by) sales of antibody tests. Pharmacies still aren't allowed to sell OTC for use by Joe Public at home.

"Don't you need MHRA approval for home use Regulator?"

It depends on what you mean by 'home use'...

The newer MHRA TPPs and PHE review process include assessment for potential non-professional use. These have been developed after the DHSC changed the criteria for the AbC19 test - which meant it had to go through further testing (at Uni of Ulster if you recall) and an MHRA approval process... which didn't actually exist.

The issue with approving antigen tests for non-professional use is that it is a test for active infection - and therefore also of the potential to infect others. Covid19 is also a notifiable disease.

I don't think int he short term you'll see antigen tests being authorised for use at home by Joe Public. Any antigen tests will need to be 'supervised' so that positive tests can be verified and reported approriately. You may see some groups of people (e.g. healthcare professionals) being able to test themselves but, in the short term that won't apply to Joe Public.

I think part of the difficulty is that the politicians' rhetoric is not always informed by the reality of the processes on the ground. Politicians are make announcements before they've confirmed whether or not they can actually be delivered.

It's a case of political promises driving policy/process - rather than policy/process driving political promises. The former is OK in a election manifesto but it's not appropriate a pandemic, where the latter is required.

It's part of the reason that the UK is in such a mess compared to many other countries. The same thing has happened in the USA.

"Not seen a named approval for innova form them."

Innova is not an approved test and is being used under a limited MHRA EUA. I can only be used as part of the National Testing Programme.