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This topic has been covered many times. If the Government want it to be for home use, they will just do the same again - put it in their NHS packaging and get the MHRA to make it so, like they did with Innova.
It's an easier test to use. Don't see this as an obstacle personally.
Craiga, 2 thoughts on this.
Think Al was talking about formal Self use testing authorization, which, if he has to jump through all the hoops would be end of year before completion, (Best guess) but to be of any use now, will be too late.
Secondly, referring to your "tomorrow" comment, yes this could, but this would be under EUA temporary like Innova are using now.
2 ways for home use, 1 totally gov depending on aspiration via EUA, the other in Avacta's hands but very long winded.
It's well worth watching the whole presentation again.
Can't update on Department of Health currently, more demand than supply. May need to manufacture in Europe but prefer to be all UK manufacture..
Or the government could just wave a wand and “make it so”. If they dan do it for chinese crap they can do it for world beating uk made product..................
Thanks Malpenn it was in the Q&A at the end 56 mins onwards. Said he had no clear timeline but has to be relativly quick but requires other studies and audit by external party and has to be this year to be useful.
That was just a tad anal.... by the end of the year implies at some point between now and 31/12.
However with AS concept of time, there could be a little slippage on that time frame ??
I hate to be pedantic but why would anyone want to sing along to boom Shakala boom?
Craig I think it was this presentation
https://youtu.be/QKc7VuKzP1Y
Hate to be Anal (I dont really ha ) and I may be wrong but he didnt say "by the end of the year" for home use. I thought he said it "needed to be before the end of the year". Your post implies AS is stating home use approval will NOT be granted until the end of the year which I think is incorrect for all we know it could be tomorrow. Happy to be proved wrong if I am incorrect as I cant find the video/presentaion where this was said now.
Previous update from AS...... we hope to have home use approval by the end of the year.
Boom shakala boom shakala...Come on Avct....everybody sing it Boom shakala boom shakala
There are only a handful of Notified Bodies that can be used to evaluate tests for home use. The process from start to finish is taking between 4 to 6 months before a decision on approval is made so, it depends when / if Avacta applied for home use evaluation as to when that decision will be announced.
AS pointed out months ago that validation for home use takes longer as it requires stricter certification.
That's a relevant question.
the AVACTA test unlike the dud but plenty sold test, is just for Professional use, as far as i am aware
why is it NOT also for peronal use, is it because it has not been tested on enough people?
all answers welcome but only if sensible and not written by clowns, so that rules out comedians like ZOOM, WILL, PL., and other like minded, you know who you are.....