Member Info for RegulatorUK

" Eddy worth a check. ? https://github.com/NHSDigital "

And the Github repository has only a portion of the publicly available NHS source code...

"FAKE NEWS.
Any code written for NHS would be secured not visible to anyone in the public domain!
Trust me I’ve worked on public sector projects before as a developer!"

WRONG!

https://service-manual.nhs.uk/service-standard/12-make-new-source-code-open

"CE certification is a public document it can be viewed as either a certificate from a Notified Body or the number can be checked with the notified body."

You are correct that CE certification is a public document. However, not all CE certifications are done by an Approved Body. It will depend on the type of device and the route to certification.

There is no requirement for a CE marked device to be registered with an Approved Body - the manufacturer must be registered with the Competent Authority (in the UK, the MHRA).

"Notified bodies include the German TUV, the Anglo Swiss SGS and the UK LLOYDS amongst others."

Lloyds is not a Approved Body in the UK for marking of medical devices. For CE marking (as opposed to UKCA marking post 1 January 2021) the three Approved Bodies in the UK are/were BSI, SGS and UL International ( see https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices )

"Do both thriva and Innova LFTs test for two separate antibodies ?"

As far as I am aware, the Thriva test is not an LFT. It's a home provided sample that's returned for lab analysis. I believe Thriva aren't manufacturers but provide third party kit - and they don't do they analysis either... that's done at third party labs.

The Innova Antibody Test is IgG/IgM.

"The tests are obviously out there in the public domain which I'm sure is generating extra income for the company. An update on this and the Mologic sales would be nice."

I'm not sure that they are. I've followed up with a few of these places that appear to be offering them and they're suddenly 'not currently available'/'awaiting delivery'. I think people are advertising them in anticipation of DHSC third party sales approval/15 February rolling round.

"CE mark is not. Requirement to enter the tender process, a PHE test 3 success and the capacity to supply is, CE mark would be needed by the supply date"

I'm not syre that is correct. CE/UKCA marking is applied when the TPP and MDD/MDR requirements have been met and the devices are ready for professional use.

From my reading of the PHE protocol for LFT evaluation, candidates for assessment are selected by DHSC at the time the TPP and MDD/MDR requirements have been met (i.e. when they are CE marked).

It's worth remembering the PHE process is to assess the suitability of tests for procurement by the government - it's not about their wider use.

I don't read it that they're selling to the public but the businesses who want to test through their Occupational Health processes. Someone has asked the question. Let's see what response they get...

Interestingly, the Hughes tests are excluded from the big £912m tender which closes tomorrow, as they're currently nasopharyngeal specimen only.

"What I would say there is I think it is standard practice by the NHS & pharma companies to dispose of clinical waste by bagging in the bags being ordered then sent away to be burnt."

If they're unused they won't be classed as clinical waste. Orange bags are for infectious clinical waste that requires heat treatment prior to incineration (normal yellow bagged clinical waste doesn't require this prior to incineration).

Looking at the size of the bags being procured in that tender, and the type of services that NELFT provides, I'd hazard a guess these are being used for disposal of waste involved with treatment of Covid patients in the community or in mental health units. Unfortunately, Covid has become rife in a lot of mental health units.

"the ones govt are sending out are using Thriva, but thats test at home and post for results"

It depends. Different parts of the system are using different tests.

The epidemiological surveillance sampling being done by ONS and Imperial/Ipsos are using a mix of Innova and Fortress, although both are planning to move to new tests (I think they've begun the roll out of new tests but may be using up some of the older ones as well).

The T&T tests, which are swab and return, are a mix of manufacturers - what you get will depend on where you are and which distribution centre you're served by. It's also further complicated in that some of the test packs comprise components from a number of manufacturers.

"its not our test but , I did raise the question about whether it indicated MHRA approval?"

At the moment, this survey is using the Innova test. My understanding is that they are looking to swap tests but they haven't confirmed which they will use.

The Innova test was being used under an EUA from MHRA - rather than having specific MHRA 'approval' under the LFT process.

"I think it was a joke"

I'm sure that's what he'll claim...

"Look at the McN post on Twitter. Lock and load for the morning surge."

What Twitter post is that? And are you sure the post is credible?

This post https://twitter.com/nadj_31000/status/1349698850085285888?s=20 seems to confuse a Tender Notice with a Contract Award Notice...

"Innova Test Being Binned :-)"

Not sure how you get that from a Tender Notice for waste disposal bags from NELFT, which is a community and mental health provider...

"Quick question... Is the deadline for the supply and delivery or for the announcement of the contract?"

The 15 January is the deadline for tender submissions. Once the Contract is awarded, delivery is expected between 5 February and 31 March 2021.

5 February is the first possible date for a Contract to come into force, subject to any standstill requirements. However, given the DHSC's record for publication of Contract Award notices, I wouldn't necessarily expect that to be published before any Contract comes into force - some are being published after the Contract has actually expired.

"Regulator.
.how do you know they have no money invested???"

Because some of them have told us - in fact, boasted about how they were oh so wise and sold out before the price dropped.

"One thing in common that we all have money invested! "

A number of those commenting do not have money invested and that must be taken into account when giving due weight to their comments...

"Soon the consortium agreement will be over and then Omega is free to sell unless another agreement is made."

I wouldn't be surprised if the silence is due, in part, to ongoing discussions to extend the agreement with the government/put a new one in place. That will be something of a balancing act commercially (with strong pros and cons)...

"They not going to announce every single sale.
Do you think McDonalds issues an RNS every time they sell a 99p cheeseburger?"

FourFiguresBull5h!t will probably suggest they should....

"I have been in a while but i think most Pis wouldnt invest here now because of his rep ."

I disagree. I think many PIs will invest in here *because* of Trevor Brown. He's proven that he can deliver.

Some people (particularly some people who were invested in RMS) get upset when his name is mentioned but that just suggests that they don't really understand how this sort of investment business works.