Innova test / Xiamen Biotime is a "for professional use only test" and rightly so given it is nasopharyngeal and nobody will willingly poke theirs or their kids brains out properly. Why do you think the real world S&S of Innova is so poor!? The MHRA basically white labelled it (hence why the one you collect from the pharmacy is in an NHS branded box) and they gave it an EUA exemption.
Hopefully with the results AVCT have produced and being AN, this should reduce the disparity between clinical and real world results. I would think this gives us a good shot at home use authorisation, but it will be for professional use only at the very start.
Here's a quote from the BMJ on it:
"Regulation grey zone
Lateral flow tests occupy a strange, deregulated grey zone. Most such “in vitro diagnostic tests” can be declared by their manufacturers as conforming to the UK Medical Device Regulations 2002. A UK approved body approves tests for higher risk infections, such as HIV, or if it is a self-testing kit. The list of high risk infections is outdated and doesn’t include SARS-CoV-2. So, manufacturers can self-declare covid-19 tests for professional use. The only stipulation is that they must be carried out by trained staff: they cannot be simply rolled out as part of a self-testing programme.
That said, they can be used for research purposes. Innova’s test was piloted for community testing in Liverpool last year. And the MHRA has issued an exemption for the Innova test so that, even though it is approved only for use by professionals, it can be sent out for self-testing under the NHS testing programme. This has highlighted the need to reform the regulations, at least in the UK."
I was having a giggle at this last night....
The practicalities of PCR never really made sense to me full stop because of turnaround times.
"You need a negative PCR test within 72 hours of your flight" then you can just hop on your plane care free.
I have absolutely no idea what anyone on that plane has been doing in the 72 hours post their test. They could literally have spent 2 days licking Covid laced petri dishes, be asymptomatic and they can still board the plane.
Surely a test done on the spot is the ONLY way to effectively determine if someone has the virus.
Of course, PCR for detecting variants from high risk countries makes sense, but green zone countries....no
Absolutely - there is a very clear push from some of the science community around the "detecting every case counts" idea and that PCR being so sensitive is the way the world should go. Aside form the fact nothing is ever 100% accurate, exactly what you say, with AVCTs S&S figures performing so well at the generally agreed Ct values for infectiousness, not only can they pick up genuinely positive cases in sufficient levels to suppress the virus but accurate enough to avoid false positives where people are actually post infectious. That then allows economies to reopen and peoples livelihoods not crushed by oversensitive PCR tests deeming people positive for isolation on viral loads too low to be infectious.
This test is a huge weapon against Covid whilst avoiding the economic catastrophe lockdown is causing at a cost of £500m a day.
Exactly that - the govt were pushing the vaccine silver bullet rhetoric whilst they have the safety net of a lockdown to help "back up" the numbers. That's the hedge to keeping momentum on one of their very few successes in this pandemic and want to keep spinning it as long as possible. Anyone with half a brain knows the lockdown is the main driver behind cases dropping. The people out spreading were predominantly the ones who are unvaccinated (under 40 with no underlying medical conditions).
Now they have committed to a reopening date and their hedge of lockdown is gone, the govt are sh*tting their pants that it will all become very clear to the average Joe that vaccines are NOT the silver bullet and the govt have been deficient in other areas. Hence NOW and only very recently the huge change in messaging around testing.
Sisu thank the lord there's still a few left on this bb that get it and share useful insights!
This is exactly what Michael Mina has been saying to quash the likes of Deeks and the anti LFT brigade. Nothing will ever be 100% S&S in a real world setting at scale....fact. So having tests that are rapid and cheap (as well as very very accurate of course) means the concept of confirmatory testing via LFT's is very much doable. PCR will then only be requires to screen for variants.
As you say, likelihood of two false readings in a row reduced exponentially with an additional test.
Think we had this debate with RegulatorUK on ODX didn't we sleepydave? March version of DPS suggests alternatives to 3A validation at PD could be accepted. So its possible it wont need to go back through them.
“Phase 3A Validation” is an evaluation against human samples containing a) SARS-CoV-2
antigens and b) samples that are confirmed as SARS-CoV-2 negative by PCR. The objective is
to ensure LFDs perform at the minimum threshold levels to be potentially suitable candidates
for use as a nationally deployed LFD as part of the Government’s Test & Trace strategy. It seeks
to validate that LFDs have a low failure rate, are acceptable for use with their operators and
achieve acceptable levels of sensitivity and specificity. It is a clinical laboratory scientist
evaluation assessment using human samples. It uses frozen human samples obtained from a
biorepository. It is important as it enables an assessment against human samples and
determines LFD sensitivity, specificity and kit failure rate. It consists of testing against a panel
of 200 known positive and 1000 negative human samples, which number may be varied as
considered appropriate by PHE Porton Down from time to time. This form of testing is
important as samples from individuals may be different to laboratory manufactured viral
particles and may lead to different performance insights of the devices. Phase 3A Validation is
currently undertaken at PHE Porton Down. During the duration of the DPS, DHSC may identify
another regime(s), whether or not undertaken at PHE Porton Down, that may or shall be used
to achieve the same objective in which event “Phase 3A Validation” shall, for the purposes of
this Specification, the DPS Information Document, and any Application, mean validation by
And the CE marking part. So CE mark will cover UK and Europe. We still need one if going for the govt tender as that is explicitly stated as a necessity to apply.
“We will continue to accept CE marked devices on the Great Britain market until 30 June 2023. This applies to devices that have been CE marked under and fully conform with the following applicable EU legislation:
Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
Directive 93/42/EEC on medical devices (EU MDD)
Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
Regulation 2017/745 on medical devices (EU MDR)
Regulation 2017/746 on in vitro diagnostic medical devices (EU IVDR)
From 1 July 2023, new devices placed on the Great Britain market will need to conform with UKCA marking requirements.
If you currently CE mark your medical device on the basis of self-certification, you will be able to continue to do so and place your device on the Great Britain market until 30 June 2023. “
Goldstandard, looks like a CE mark covers UK sales until 2023 according to govt website. It also says on the tender docs CE marking is a prerequisite so don’t think there’s an immediate need for UKCA marking, which is good!
“ Manufacturers can use the UKCA mark on a voluntary basis until 30 June 2023. From 1 July 2023, a UKCA mark will be required in order to place a device on the Great Britain market.”
Patelaz - Yes the UK is in Europe geographically but there was this thing, Brexit? Avct refer to them very distinctly. Hence why investors do the same e.g
“ Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, announces that it has received the first data for its SARS-CoV-2 rapid antigen test from ongoing clinical studies in Europe and the UK. ”
Mologic did 28 for their CE mark:
"Independent assessment at Liverpool University Hospitals NHS Foundation Trust, as part of the FASTER study with 28 patients presenting for care, resulted in a sensitivity of 92%, and a specificity of 100%, corresponding to RT-qPCR-confirmed COVID-19 cases. Limit of detection studies estimate a 50% Tissue Culture Infectious Dose (TCID50/ml) of 100-350 (<5×10^2 pfu/ml), a key tool for estimating the infectious titre of a virus."
Don't forget up until recently the dominant strains were different in UK and Spain so I think the two distinct CV sites were for that reason.
Again, removing any opportunity for the tests to come under negative press when on sale.
Yep and using AN is more than likely to produce more consistent results in the real world setting.
The exact issue Innova have with clinical Vs real world results. A nasopharyngeal test given EUA for at home use, who is really going to poke their brains or their kids brains out properly if allowed to do it unsupervised?
Avacta's AN tests should yield much closer clinical V real world results.
Agreed PL - I don't think they have made enough of a point about these results being achieved using Anterior Nasal swabs. They've not just blown competition out of the water in terms of S&S but do it using a non invasive sampling method which is clearly harder to do.
The results are unbelievable!
Bump - at least a few of us get it PAH!
Building s skyscraper doesn't happen overnight and the foundations for a brilliant business model are being strengthened day by day.
Rare you see something like this on AIM - a company built properly and for longevity. Then you add the fact that the Affimer IP is being further endorsed day by day - which AVCT OWN!!
Self declaration, no mention of Mologic, wonder if we're going this alone and don't need to do the CE mark transfer now?
Maybe its a case of waiting the few weeks for AVCT's own CE mark is the same timeframe as what Mologic CE marking then transferring would take.
Christ wyndrum it’s 8:30 am!
Just remember not everyone has been engrossed in Avct for the past year, plenty will have never even heard of the company.
This further derisks the investment for holders and our resident “concerned” brigade but it’s going to take some time for it to get full traction.
Some may still want cold hard orders / others ce marking complete.
Everyone on this bb wants it all yesterday. Perfection takes time.
Anything ever satisfy you?
Such good news, we all knew it was coming just had to put up with the trolls in the news quiet period.
Congrats to all the LTHs and ones who have defended what this share has to offer. To all the “concerned” - time to shut up, to the tolls haha F You! To any who sold on the deramping it’s a shame but a lesson. To Visainn LOL!
Very interesting still nothing on CV in the UK site.
For me this screams Avct hand forced by govt but who knows?
Test on the market early May in Europe