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Our bioinformatics department is worth its weight in gold. Now more than ever. A rigorous approval process backed up by strict regulations is good for the UK and ncyt. Less competition from the company's that couldn't even tie our shoelaces. Quality will win through in the end and cream always rises to the top.
Neilrich,
having just read through the guidelines for testing companies you published I am struck by the detail required to get approval.
You'll need a degree in mathematics and the laboratory skills to pass these regs, I seriously wonder how many companies can muster this expertise?
The scandal over Innova and other chinese products points to more rigourous approval proceedures in which companies like nova,thermofisher,perkins elmer spring to mind and we know for sure that nova have compatible products designed to work on several pcr platforms including their own machines (and the obvious similarity with the tata systems observed).
Labs without high clinical standards have been found out recently and many companies appear to be fraudulent or slipshod over results.
The Chinese tests that were on the market before this new process was introduced were exempt from having to go through it.
Sorry
The tests we are currently using
Ffs
Latic
Is that defo the case that the tests we are currently approved or do you mean they were approved under a different process?
Chinese shi te is exempt from the same approval process as uk companies have to go through.
I wonder why !!!!!!!!
Sir digby, the BMJ must have been lying when they said innova were between 30 and 70% accurate. They’re obviously over 99.9% specificity to achieve approval, yet we still haven’t.
So all 21 devices submitted for accreditation have not been deemed fit to pass after 4 months? someone at UKHSA is royally taking the **** out of UK diagnostics.
Neilrich3 thank you, the obvious question being are all these companies incompetent or are the guidelines tricky to follow.
Wilson, My response from the DHSC below, it would appear that many companies have had to resubmit having failed to submit all the correct appropriate info in the first place.
.....Also, if the application data was submitted not according to our technical guidance ( https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/covid-19-test-approval-step-2-process-for-desktop-review ), as you see in the guidelines, we have to stop the process and go back to suppliers giving them 20 working days to provide the information – so that is an additional time frame that needs to be taken into consideration.
Tks Drb I'd presume that was late In The day
as the share price was up almost 5% today tomorrow will be of interest to me.
KT I wonder if that means none are acceptable now or are they still bizzarley checking them all, they are probably all locked in an iso container near Beijing:))))
Re CDTA Copied from Avacta board
Finally the FOI responseToday 17:18
Remember the FOI request I submitted in Nov. After chasing three times in December and providing the link to the review on the government website because they said they didn’t know what review of LFT s I was enquiring about and then they needed another 20 days to answer the request.
Here is the main response
“ Response
Please see below for responses to your queries:
How many staff are reviewing Lateral flow tests for use under the new regulations in the U.K?
There are five full time equivalent scientific advisors reviewing applications for approval under the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (CTDA).
How many tests have passed the review and how many companies are currently waiting for their review having meet the deadline of September 1st and paid their fee?
21 companies applied to CTDA with lateral flow devices prior to 1 September 2021. As at 17 January 2022, none of these 21 lateral flow devices have been approved under CTDA. Lateral flow devices from 13 companies are currently included on a temporary protocol (Medical Devices Regulations 2002: protocol -
1
GOV.UK (www.gov.uk)), which means that they can be sold on the private sector in the UK.”
Wilson, take a gander
https://www.gov.uk/government/publications/covid-19-test-validation-approved-products
Drb you got that link pse.
20 January 2022
Removed Oxford Nanopore Diagnostics' LamPORE COVID-19 test kit from protocol list.