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DRB83, thanks for that link i've now got IFU 10 :)
Statement from the South African president yesterday.
https://sacoronavirus.co.za/2021/11/28/statement-by-president-cyril-ramaphosa-on-progress-in-the-national-effort-to-contain-the-covid-19-pandemic-28-nov-2021/
Agree with that list Exmex. Yes Kaeren
Agree Kaeren.
That's a difference in viewpoint then Poidster I'd supply after they've paid what is owed and money up front for the new order.
One things for sure, there will be a huge demand for PCR tests 100 % agree with you there.
Can somebody tell me what the Telegraph article says please. I can't access thx
I think the biggest challenge now for Novacyt is going to be keeping up with demand. I think DHSC and therefore the UK will suffer. All this messing about over the contract is going to hurt the UK.
DHSC may well find themselves at the back of the queue, tbf, if I was in DAs position I'd tell them to go forth and multiply. They screwed the company when they thought the threat was over. Anyone with a brain knew this winter would be bad. DHSC need to settle up, pay their dues and place another massive order and stop messing about.
Remember the phase 2 that they cancelled, if they would have implemented that then community testing would now be well established and providing a much needed testing capability. But no, they decided not to go ahead and are now panicking.
We are truly led by morons, they are culpable for so many deaths
That's what I think Exmex
Yes Dr posted about it earlier released Aug 21.
Think we are singing from same hymn sheet now.
The other eight tests awaiting review could be the following.
Genesig 2 gene
Genesig 3 gene
Genesig 3 gene high throughout
PROmate 2 gene ( for use with the Q32)
Winterplex
Escapeplex
Professional use rapid antigen test
Private use rapid antigen test ?
AK Gabba
You'll find version 10 on the PROmate 1g test.
Didn't realise we had a PROmate 2g test. Not a s gene target though.
http://www.primerdesign.co.uk/products/10059-promate-covid-19-covid-19-2g-2-gene
Hopefully Novacyt can contribute in supplying efficient, quick high quality test results.
https://www.telegraph.co.uk/news/2021/11/28/price-covid-testing-kits-set-soar-wake-new-omicron-rules/
Thanks Exmex AGAIN! K
Sorry about that . The snpsig genotyping tests are used as reflex tests ,where the covid test has already been done beforehand. Escapeplex does contain a standard covid test as well and is probably one of the tests awaiting desktop review.
Fair point Kaeren and makes sense. That could cover 5 of the 16 which leaves the 11 that we put forward. Will be interested to find out more from the horses mouth next week.
Variplex
ak_gabba, you are correct. The PROmate test kit for the Q16 contains the pre loaded reaction tubes in a circular cartridge, whereas the PROmate test kit for the Q32 has strips of reaction tubes to suit the test device.
DR , I could be woffling.
SNPsig not used to diagnose covid just to determine what variant.
On sale at Vic scientific in states , does not require FDA approval .
May well find SNPsig not awaiting approval as not required.
Hillseeker, yes but assumed the SNPsig range would include at least 5 tests so I guess it's safe to say we have no way of knowing exactly what the other 8 tests are and why only 8. We have more than 11 in total. Is it about 16 from memory. What about the new ones. Hiberplex, RESplex ect. Maybe they aren't covid related. Still haven't been RNS'd either so maybe not launched yet.
Also, still awaiting the RNS for the launch of Coprep. So much positive news to come and with so much positive sentiment and from such a low SP base. It is going to be an interesting Monday.
Hillseeker and DRB83,
I think you are correct. The promate on the exempted list could well be 2 tests.
https://www.primerdesign.co.uk/assets/files/path_promate_covid_19_ce_sted_ifu_issue_600.pdf
They are listed in the IFU issue 6 as being 2 catalogue numbers
genesig® q16 (Catalogue: D00050)
genesig® q32 (Catalogue: D00051)
That would make the exempted promate as being 2 tests and the recently approved test being 1 leaving 8 to be approved.
Interestingly though I notice that on the link
https://www.gov.uk/government/publications/covid-19-test-validation-approved-products/medical-devices-regulations-2002-protocol
Promate is listed as IFU issue 10.00 (23rd July 2021). I'm only able to find issue 6 (25th March 2021). Can anyone find issue 10 or previous? It looks like the IFUs have gone through quite a few updates. Looks like they are listening to their customer base :)
Hillseeker,
Ah! I see what you mean. It does mention 8 waiting on approval however I only see 1 approved and 1 exempted. I read the same promate test but for 2 devices. It also refers to each test in the singular.
sorry, DRB - you beat me to it ref two approvals counting as 1
Are you missing SNPsig? I 'm not sure SNPsig and EscapePlex are exactly the same. Either that or there's more than one version of HT test, genesig HT and genesig 3G HT.
@ak_gabba
I agree - 3G most likely still pending. But check your maths again, or read the RNS further:
"Further to the validation of its genesig® COVID-19 test, Novacyt's Primerdesign Ltd PROmate® COVID-19 test (encompassing both the PROmate® 1 Gene q16 and q32 products) remains on the temporary protocol and continues to be supplied to the NHS under the PHE National Microbiology Framework. The Company awaits updates on the additional eight products submitted to the CTDA across its COVID-19 testing portfolio."
The Company awaits updates on the eight additional tests. One approval encompassed two tests, so that's what led me to speculate that the same may apply here and the one approval may include the entire genesig®COVID-19 test range. I doubt it, but it is a possibility. What is for certain, and we agree, there will be huge pressure to push through all the remaining approvals.
Hillseeker, yes correct. We need ncyt to clarify but I suppose they will only do that if the 2g or 3g test do identify the s drop out.
AK Gabba - PROmate counted as 2 tests (one for each machine) so only 8 to go.
2g
3g
HT
Winterplex
LFT
Escapeplex
Antibody
What am I missing?
Not forgetting media and Gov panic