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You had to do an LFT within 48 hours of flying home under Amber list rules at the time, as well as a day 2 PCR on return.
Interesting. Who/what was the test for? The UK gov 2 day test has required PCR til now surely?
CO - I used Prenetics when I travelled back from Spain in Sept. it was a Hughes test. Did it all myself following online instructions, without video supervision. Just had to register the test, photo the result, and then got an email with confirming the result.
Have read through the document for a bit of morning fun. Couple key points:
Yes the tests used will need a CE mark, but that has to cover the proposed use case. From section 4:
“The Medicines and Healthcare products Regulatory Agency (MHRA) has published target product profiles (TPPs) for different types of test, setting out the ‘scope’ of what that test should be used for, including target use, target user and target use settings.
The provider must declare that they’re using the test in line with its published scope. MHRA has set out guidance explaining how both virus and antibody tests work.
The manufacturer’s Instruction for Use (IFU) set out the target use, target user and target setting and seek to ensure that, for example, the tests which are being sent for self-administration at home are the right sort of tests for that purpose.”
In other words, if the test is to be done at home, it needs to be a CE mark for that purpose. On the one hand, we haven’t got that yet, but on the other, if/when it is granted, it is a less crowded market place.
And back in Section 3, about the need for a CE Mark:
“This requirement is to ensure that the testing device has a CE marking (or, following the UK’s exit from the European Union, a UK marking) and does not benefit from a derogation from those standards.”
This would imply to me that exceptional use authorisations previously granted (eg which allowed Innova to be used at home) will not apply in this case, which is great news for levelling the playing field.
HP, what test provider/brand was it, and what country? I didn’t think this was in standard use in Uk already…
Hp, but no actual indication it was you that did the test?
This is now an extremely crowded market place, where the cheapest & easiest to use will start to dominate. Vast majority of Day 2 test users will prefer to undertake at home, AffiDX needs HUA fairly quickly now to capture a decent sector of this travel market.
It was kind of clear after reading the provider guidance, that neither avacta or m19 are likely to be providers as such. A provider is the one checking the photos of the test result etc. Their game is supplying LFT's at scale, hence why the NHS microbiology framework is going to be more significant as a starter.
I had to do a home administered LFT a few weeks ago for a trip.
I had to write the date and time on the actual LFT.
Once the result was inI then had to photograph the test beside the photo page of my passport, then email the photo to the test provider within the time frame 15 to 30 minutes after the test was taken.
Negative certificate was issued 30 minutes later.
Cost of process £28 a test.
Crucially…the provider is responsible.
I would be crying into my plonk this evening if Alastair Smith was responsible for this! Take note
@DSWilsonDx
Outsource this to
@medusa19_
and all systems go.
Medusa just need sufficient capacity now and a savvy sales team. Oh… Care of Hondjoe Twitter.
Presumably m19 would not be a test provider in all of this but rather a supplier of lateral flow devices to the test providers. Unless of course they have been gearing up behind the scenes to perform this service and or have something clever up their sleeves related to saturn pass. Who bloody knows any more :)
Anyway, this whole process seems like it will be a resource intensive bottleneck and ripe for circumventing by unscrupulous types, as we saw with some PCR providers. It's the usual half baked mess coming out of Whitehall.
Have you got a Bob Monkhouse crib sheet?
Wow thank you for posting. Bit that struck me was
7. The test result must be verified by the provider with, as a minimum, a single photographic evidence when the provider does not witness the test service (self-administered tests taken over video call still require photographic evidence)
The provider is responsible for analysing and verifying the result and reporting it to the UK Health Security Agency (UKHSA). The test result must be verified by the provider with, as a minimum, a single photographic evidence, when the test is self-administered meeting the following criteria:
the lateral flow test device must be identifiable as the test provider’s
the photograph must also show the international arrival’s unique test booking reference
the result must be clearly visible
So I think this means you can do the test at home. What isn't clear is do you need to do it over video link and does that constitute professional use. I certainly hope so (despite HUA any day now).
Providers have to have MD or equivalent to oversee SOPs - probably in the belief that medics don't want to get struck off. Nice work if you can get it.
validation must have used at least 450 test samples. could you please point me in the right direction to the above must have missed it scanning through cheers.
I finally started my fitness regime this morning. Got up and ran around the block ten times.
Then I kicked the block back under the bed and cooked myself a nice fry-up.
Kia Motors and Apple are cooperating on the world's first self-assembly car.
It will be called the iKia.
I'd forgotten how to use the car seat belt, then it clicked.
Now I'm not saying the Proctologist I saw today had the biggest hands in the world,
but he was definitely up there.
Got a headache going through all referenced documents.
It seems to be weighted towards technology used by current tests and says validation must have used at least 450 test samples.
As I said a few days ago, the Boohoo boys will push our tests hard.
Why?
Big mark up, no returns, cheap to post/pack, little warehouse space, existing customer base, easier than Saturday night rag trade frocks….and more profitable.
Medusa19 diagnostics PLC….ex Location Sciences Group PLC…….. another buy at 0.5 pence too?
These latest travel requirements are an #avct Shareholders wet dream. CE mark is enough. And if there is one thing Medusa’s owners know it is how to sell millions of low value items to the public. Day in day out. This is better than dealing with HMG any day. Care of Richard Armstrong Twitter.
Gov Guidance on LFT for travel is out.
Nothing in there that stops a ultra bullish Medusa selling AffiDX.
There will be no approved list so marketing and capacity will be key.
Good job they are the best in the business then. Care of Little Gunner twitter
Penalty for not ordering Day 2 Test prior to UK arrival £1000 or £2000 if none compliant and still don’t purchase Test as soon as possible once arrived. It’s a Fixed Penalty Notice without discretion.
What penalty for not following rules through ADHD or Gov.UK contracted mania?