Member Info for tecbadger

welcome to the madhouse

JAdam i see it as a reasonable speculation. My view is that because it is cassetting and pouching activity its unlikely. Cassetting implies a manufacture of a finished LFD from reagents and the plasticware whereas pouching implies either a packaging or a repackaging activity.

My opinion is that since we know Innova were supplying finished LFDs within Innova branded boxes for NHS trials before the rollout to the public that it is likely that these are being repackaged rather than cassetting also being done.

opinion based upon wording only.

Getting the CE isnt the hard bit (yet) getting through in country evaluations and getting orders placed is. Visitect is still at porton down and we dont kow the status of evaluations elsewhere. Hopefully recent news will lead the government to adopt a UK test sooner rather than later.

Sad to see but this is only partial information. Would be good to know if these people recently had their second injection or whether there had been a gap of 2 weeks before infection and also if they had any co-morbidities

CoffeeCups nice one!

MRIgoat agreed it shouldnt be that aggressive. BigBangs has it spot on. Hell maybe they could even send all the data and reports to Michael Mina and see if he would give a tweet.

Lets put it this way if i were in the marketing team at Omega id be going hell for leather differentiating the product from Innova right now

Well thats what happens when you dump someone with no medical background into the health minister role

Now would be a good time for the company to engage with the press and communicate the many positives about the visitect product they are offering.

1) Validation by FIND (i cant stress how massive a name they are in IVDs) in Germany who have confirmed the product meets WHO target product profile
2) Validation within the NHS including validation of self sampling
3) British designed (mologic) and manufactured by companies with prior expertise and regulatory ertification

etc etc

rocquet i also ohold AVCT bu we can't bury heads in sand over this.

Its not approval-->sales its approval--> in country evaluation-->sales and i think people miss this distinction.

Just remember approval and sales are different thing. 99% of the time member states will want to do their own clinical evaluations before buying if the EU even have an appetite to buy from the UK at all right now.

70p paid. Happy Thursday!

Smallpeno has been stinking up the ODX board for a few days now. Uber troll and posts very similar to one of out previous trolls S.A.TAN.

Give them the hard swerve

First share i ever bought this. Baptism by fire

PL75 thanks for sharing that. Data presented in a favourable way for marketing as for the higher CTs they include all samples from the lower CTs I.E
Ct 29 sensitivity is given on all samples 0 to 29
Ct>30 sensitivity is given on all samples regardless of CT

I've not seen that before and it's a little scientifically misleading as the true sensitivity greater than 30 is 50% with 2 samples shows one true positive and one false negative.

I'll be having thay way of displaying data hahaha

Potteryexpert stratification by CT value impacting confidence of the positive is admittedly not something I had thought of and will have a good think there perhaps there could be a non traditional measure if confidence attributed to sensitivity as a result.

What are your thoughts around negatives and confidence of specificity? Best debate I've had in a while on these boards.

NDN71 your point about competitors is fair. I accept that

Beinthelead by significant I mean an accurate assessment. There is no way this test works 100/100 in the real world with all the potential variance in co dictionary, setup and users. Higher sample numbers give higher confidence that the results you are seeing on sensitivity and specificity are close to true performance. Lower boundary of the 95% confidence interval is a far more valuable number than the headline sens/spec.

You are a very defensive sort my good man i am simply pointing out the process. I hold both ODX and AVCT (although my interest here is more precision oncology)

You can ask the CT question all you want in fact CT is not 100% relevent since the RT-PCR references are not being monitored by standards to ensure the values are not affected by instrument performance drift. The fact of the matter is Innova has been given approval by MHRA so they must have been happy with the performance of the test AVCT and Mologic still need to go through this process.

Ive been in this game far too long for strawman arguments to work on me.

SneakySimonthats another valid point it really gets under my skin the partner hasn't been shared. With mologic we see great institutional names as partners in clinical Eval like the NHS and FIND. Why won't AVCT name their partner?

Will hunting its my job getting IVDs to market.

AVCT have MHRA marketing approval so you could certainly take it and stand outside the hospital and sell it to punters and then through post market performance follow up processes attempt to make performance claim enhancements however you would need a reference testing result to confirm the call made by the LFD was correct.

This is why clinical trials are needed. Massive ones because on 200 samples you cannot make a very good claim that the 100/100 performance was not affected by any bias or the fact that its simple for operators to perform 200 tests well. You need studies documenting 1000s of samples from different regions/countries/continents/ user populations to make a strong statistically valid claim on performance.

It's a fact of our industry and one of the main reasons getting to market is difficult.

UK guidance states a product t has to pass Porton down trials before being accepted for government purchase.

That is the Innova performance. Specificity stated at 99.9% meaning false positive rate is 1 in 1000. Avacta still has to be cleared by Porton down yet and the 200 samples tested so far in clinical evaluation (that we know about) is not statistically significant.