Member Info for RegulatorUK

"I assume they’ll use the innova branded Chinese kits there that was stated last night not fit for purpose"

The Innova test kits *are* fit for purpose. They have been evaluated and passed as such by the PHE team at Porton Down (and they are the experts).

The problem is that people assumed (incorrectly) that mass testing would be self-test at home. It won't - and it can't be entirely self-test, for a number of reasons. Antigen testing will need to be done as professional POC testing.

If the government have any sense, the testing in Liverpool will follow this process:

(a) Antibody LFT.

If negative, then:

(b) Antigen LFT.

If positive, then:

(c) Molecular testing to confirm positive antigen finding.

This would substantially reduce the cost, given an overview of antibody prevalence and reduce the risk of positive cases being missed.

But we have to remember this project is being led by Serco Test & Trace/Dido Harding's NIHP - so they won't do the logical thing...

There are two key decisions that will really push the ODX share price up:

(1) MHRA self-test use approval for the antibody test; and
(2) Mologic CE marking its antigen LFT.

I suspect both of those will happen this month.

Soddit! My Covid portfolio is doing OK and I needed a new light for the bikepacking bike, so I've invested in one of these:

https://www.bumm.de/en/products/akku-scheinwerfer/parent/196/produkt/196l.html

And I've ordered a new sleeping mat!

And we're off!

My Covid portfolio has already bought me a new ultralightweight tent and walking poles. What next? Upgrade the down sleeping bag or the sleeping mat?

A quick look at his posting history shows what an inadequate individual he is.

...today could be fun!

I may have taken the L&G opportunity to top up.... ;-)

Zuo de!

"What a great RNS. According to the presentation last week this is one of our most profitable products. Good to see our core business is being looked after. An MHRA RNS next would be great plus an update on LFT will see this at 150p. It's going to be an exciting few weeks. Good luck, Brighty"

I wouldn't be surprised to get an MHRA-related RNS this week.

"A breathalyser is an 'indicative' reader at the roadside. They will always take you to the station and put you on a much more sophisticated machine to get an accurate reading. Plus they will usually test you twice and take an average."

That's because, for evidential reasons, they need a precise measurement. That's not the case with testing for a virus - you just need a positive or negative.

Be interesting to see if this has any effect pre-opening...

Enough of the daft conspiracy theories.

No. It should have happened more than a month ago and the government has now been forced into it, due to pressure on the NHS.

“ If super drug can sell a test to the public without the MHRA home usability approval then why can’t ODX...”

Superdrug can’t. Simples!

In most cases, IgM is only detectable (as opposed to present) at the time someone is symptomatic. IgM testing was being used as a proxy for antigen testing early on in the pandemic but was stopped due to being unreliable in the early stages of infection.

"If I get an antibody test, and it proves I have antibodies, could I actually also be asymptomatically infected ?"

Antibodies indicate a prior infection and suggest a level of immunity, so it is unlikely that you would be concurrently asymptomatically infected - but one thing Covid is teaching us is not to assume anything.

It would potentially be possible for someone who has immunity to act as a infection vector, if they came into contact with infected material and transferred it - but it's relatively small.

"You may have a point, could be your local test centre, turn up, do a test in the car and show the result. Its then recorded. Or going to collect a POC test at your test centre for some people and its recorded when they give you the test only for you to do it at home. NHS and care homes may have completely different rules."

Antibody tests will become routinely 'self-test' done at home. It is unlikely that antigen tests will - they will be restricted (in the near to mid term) to supervised use.

"Eventually it will be purely home test. This government hasnt got the money to keep having centres open and Boris is a true believer in people using common sense."

The testing centres themselves aren't that big a cost, in the overall picture. It's the charges for consultancy that are swallowing large chunks of money. There's also significant existing infrastructure/capacity that could be used (but which has been, to a greater extent, overlooked by T&T to date).

And Boris may not be around for much longer, if the 1922 Committee has its way...

"Pregancy being a well known notifiable disease"

*Snork*

You owe me a new keyboard TWatcher... this one is covered in coffee. :-)

"So for the antigen tests like ours (Mologics) and the ones UKGOV has ordered from China, they will or will not need MHRA to be used at home - I think from below just a CE mark ?"

All self-test IVDs (other than those in Annex II) need specific MHRA approval. This includes *all" Covid IVD/LFT tests - both antibody and antigen.

Whilst antibody tests will get approved from self-test use at home, this is likely only to be in relation to NHS/PHE/ONS testing. It is unlikely you'll be able to buy a UK-RTC test over the counter in the short term.

MHRA may approve a self-use antigen test but only with strict controls. This is because antigen (and molecular) tests are used to test for active infections - and Covid19 is a notifiable disease. It is probable that antigen LFTs will be used primarily as professional POC tests or self-use in test centres, so that positive tests can be recorded correctly and the appropriate PH notifications made.

"Regulator- if your going to debate them at least have an argument. It’s not about who has access to the test , that is irrelevant. The fact is that odx are making them and news directly through odx or Abingdon counts. Simples read the EU directives."

I know what the rules are and what the Directive says. I also understand the very clear response given by CK in the recent presentation when asked about orders and RNS.