Member Info for Da-Doo-Ron-Ron

Here it is in black and white. Penultimate paragraph:

https://www.gov.uk/government/news/travel-update-47-countries-and-territories-removed-from-red-list

Well done AgentB! Anyone interested in responding needs only to click on the link below and under the heading ‘Ways to respond’ there’s a link ‘Respond online’.:
https://www.gov.uk/government/consultations/proposal-for-mandatory-covid-certification-in-a-plan-b-scenario-call-for-evidence

Yes Agent B. ‘We are now in a situation where it is deemed safer to be in close proximity with double-vaxxed people who can still shed the virus than with people who take a negative LFT.’

I’ve posed a similar observation in a response to the government’s consultation regarding covid certification at large events: https://www.gov.uk/government/consultations/proposal-for-mandatory-covid-certification-in-a-plan-b-scenario-call-for-evidence

So as well as evidence of double vaccination, a LFT should be included in the price of the ticket and a negative test (bring on HUA!) a requirement for admission.

Anybody else fancy chipping in to the consultation? Submissions must be made by 11th October.

In view of PMI’s financial strength and their wish to pursue new sources of revenue, I’m surprised today’s counter off isn’t higher than 165p to shut out Carlyle permanently.

PMI have just upped their bid to 165p: https://www.msn.com/en-us/money/companies/philip-morris-heats-up-race-for-vectura-with-14-billion-bid/ar-AAN4qZl
Will Carlyle come back in?

Any signs that Boris and Douglas Ross might drop by Alva? You know, cones in the car park, clean Director’s cars or fresh paint for the front door? If good news is about to break, the two of them will want to get the maximum kudos from it.

Pigster: Check out the downloads mid way down on this page https://www.gov.uk/guidance/covid-19-test-approval-how-to-apply The testing thresholds for sensitivity are put into four bands dependent upon the settings for use.

DHSC has just published greater detail as to how test manufacturers or distributors can apply for approval of tests to sell on the UK market.

While we’ve been aware of the impending desktop review system there is now formal confirmation of the requirement to include::

Evidence of performance characteristic including materials and method for limit of detection and Raw CT data per gene target for the comparator RT-PCR results and the Raw CT data for the submitted assay

Clinical Validation Desirable: 150 clinical "Positive"; 250 clinical "Negative" as determined by a comparator laboratory RT-PCR
Essential: 100 clinical "Positive" and150 clinical "Negative" as determined by a comparator laboratory RT-PCR

So let’s crunch some numbers. The size and weight of a parcel, if similar to the current NHS test pack, would qualify as a ‘Large Letter’ which has an online price of £1.83 for next day delivery by Royal Mail for just one item. If we assume a 25% discount (it could well be more?) for a volume order of this magnitude then the unit price becomes £1.37 or thereabouts. So the £269m contract at £1.37 equates to 196m home tests. That would indicate to me that the order quantity is probably around 200m to cover the 12 month period. So that would work out at 16.6m tests per month. Does that sound about right? Since the contract is for home delivery we can assume presumably that any testing to be done at schools would be delivered in bulk and would require additional production quantities.
I have no doubt that if I’ve got something wrong then it won’t take long for someone to tell me.

‘To help their professional customers establish which product best meets their needs, the Bioserve web page should provide a spreadsheet giving S&S, Ct values, application process (AN etc), prices etc for each product they have on sale. It is unrealistic to expect busy customers to drill down into each product specification and then undertake their own comparisons.’

One column should include: Detects Delta Variant? Y/N

To help their professional customers establish which product best meets their needs, the Bioserve web page should provide a spreadsheet giving S&S, Ct values, application process (AN etc), prices etc for each product they have on sale. It is unrealistic to expect busy customers to drill down into each product specification and then undertake their own comparisons.

While this board understands the relevance of Ct values, the general public is unable to differentiate between one LFT and another. I just hope that Calibre and Medusa can come up with something simple which can be easily understood. How about AffiDX being the gold standard linear flow test?

Has Avacta supplied AffiDX LFTs to the government for their Events Research Programme to get large audiences safely back to live events? Or have they used Innova LFTs made in China and subject to a Class 1 recall by the FDA and instructions to be destroyed and put in the trash?

So is is yet another hurdle imposed by government or will it provide evidence that our test is the best by far?

https://www.gov.uk/government/news/government-sets-out-laws-to-validate-accuracy-of-private-covid-19-tests

This is as we thought - the registration process isn’t subject to performance review:

‘Thank you for your enquiry.
Can I suggest that you have a look at the following, if not already done so : https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work
The UKCA/CE marking of such professional tests requires a self-declaration process undertaken by the manufacturer with no review of performance data by any EU Government Body or Notified Body and that MHRA does not approve such products.

KR

Rob Higgins
Senior Regulatory Affairs Manager
DRG | Devices Regulatory Group | Medical Devices

The UK has left the EU, and the transition period ended on 31 December 2020. Click here to find out more. Information specifically on regulation of medical devices from 1 January 2021 can be read here.

So news must be imminent surely.

This press release was published early this morning:

https://www.gov.uk/government/news/testing-and-sequencing-of-sewage-ramped-up-to-help-tackle-covid-19-outbreaks

Sparkplug: The last time you invited us all to “stop whinging and grow a pair .Things will come good in a month or so”. That was on 10th December.

Under the heading RE: CSC 51187 CE Mark, Adam from the MHRA’s Customer Service Centre has referred my query to their devices experts. At first I thought that 51187 was the CE reference number but I now realise it’s just the number assigned to my enquiry.

So will my email this afternoon to the MHRA get a reply?

Avacta Group plc announced that the Declaration of Conformity for CE mark of its AffiDX® SARS-CoV-2 antigen rapid test for professional use was submitted to the MHRA through the Group's partner Mologic Limited on 10th May.

Would you please advise whether the MHRA has issued the necessary authorisation and if not please explain why there has been a delay.

I would appreciate hearing from you.

The auto-response was immediate but I have reservations that the Customer Service Team will be as speedy.

In order to differentiate the Avacta LFT from the poorly performing Innova test made in China that has been the subject of much academic criticism, should we now refer to it as a Supertest? By introducing the concept of a Linear Flow Supertest (LFS) it would show a clean set of heels to its insensitive predecessor and justify its use in critical applications such as air travel, border control, cruise liners etc where consumer confidence is paramount. Very few people understand the relevance of Ct values so we need a marketing umbrella that encapsulates accuracy and regulatory approval of a high standard. So how about the sovereign Avacta AffidDX Supertest?