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@giz
As I have said in previous posts, you need to remember the context of the situation at that time.
NHS labs only get accreditation by proving they are fit for purpose.
That was stretched during covid.
Also, im not directly saying that they didn't follow these protocols.
However, these facts need to be tested and examined thoroughly.
Given the amount of money at stake, plus the reputational damage.
Nova should leave no stone unturned.
Someone coming after you for over £100 million because THEY say your test was faulty had better make absolutely sure that they are squeaky clean and adhered to proper protocols.
I am not for one minute suggesting that they didn't do all of these things.
But as a defendant, these questions absolutely need to be asked of the claimants.
I would absolutely want evidence that the test was implemented properly.
Especially given the crux of the matter seems to boil down to user error vs faulty test.
DHSC need to unequivocally prove its the tests that are at fault.
Given everything I've written and know, there's zero chance of that happening.
How can a test that has passed CDTA be called into question?
This is the second time you have sought to undermine the credibility of things I have posted.
Could I ask why?
Do you hold nova shares, i do, im showing a 90% loss, my fault.
Whats your position ??
Do you hold shares?
Are you shorting them?
I think its only fair that you declare your position, just for transparency
Your comments don't reflect those of a LTH, quite the opposite in fact tbh.
As you were
P.
Hi poidster good post ...it paints a very sorry picture of NHS labs ...it reminds me more of the lighthouse labs set up with PhD students and volunteers ...not bound by the very strict regulatory structure and staff training at NHS labs .....id like to believe your mistaken 100% ? ..to.. 59% ...5 Vs 2...wrong way ...nothing adds up fella ...Mr kidd would be helpful
Hi P, you may not be a lawyer but you have a fantastic grasp on how a judge might approach matters. Keep it coming. Nothing to add, not long now.
Especially one who worked hard, but as with all mass hire jobs… got dumped on! As dhsc are now doing to Nova!
#JustOne thats all it needs imo dyor fingers crossed
Staff who used them… only need ONE to come forward and say….
Due to the urgency of the situation… I was just told to get on with it?
Just one out of the many Labs? And #Slamdunk robustness goes out the untrained / weakly trained / sort of trained window!
@B2H
wrt training, there will have been a train the trainer approach from nova.
Nova will have trained usually senior staff in each lab. Once both nova and the lab were happy with using the equipment it would have been signed off as all OK.
It would then fall to those lab staff to cascade that training out to the rest of appropriate staff (be interesting to know in the labs that had high failure rates, what level of staff were using the Qs. Were they qualified biomedical scientists? Or unqualified APs associated practitioners)
Another question for twiggers to ask perhaps.
Normal training protocols in a lab requires teaching the technique, then observation of the trainee using machine, if OK person signed off for routine use.
This is standard practice, not 100% sure if its mandated but accreditation of labs, requires evidence of robust (lol) training protocols.
Was this model followed by all labs?
Can they provide evidence of robust training protocols of ALL staff using the Qs
Again, more questions for Twiggers to ask.
Were the correct decontamination procedures followed, all the time.
Can they provide the SOPs for the decontamination procedure, does that align with the IFU from Nova?
As I've said before, so many potential points of failure.
If the dhsc cannot provide this info (who knows tbf) in conjunction with 2 labs having no issues, it casts a not insignificant doubt on it being 100% a faulty test.
My personal opinion FWIW knowing the above facts, doing a root cause analysis of failure would be to immediately look to user error before even considering a faulty test.
I'm a scientist, not a lawyer so I don't know what the burden of proof required to decide is, in contract law.
But there is a lot in what I've written previously that would cast serious doubt of it being a faulty test.
Given the propensity of my posts to go missing in action, somebody of influence is reading these posts.
Please copy in case it goes missing again.
As you were
P.
Hopefully they have Filtered these Chris. Like most of us have.
At my age life's too short !!
They’d also have to wade through all the garbage too!
"Poidster hi , perhaps worth sending a message to Lynn Rees informing him of the other lab."
I would like to think they are reading the comments on this site. K.
More knowledge is never a dangerous thing and who knows they more pick up on something from Poidster's nuggets of
wisdom.
I agree Kaeren. It would be great if you could forward on Poidster, I'm sure the company have this up their sleeve but nothing surprises me and would be worth getting it to the forefront.
Hi B2HS2L......he's not looking too well ...interesting post on roq R/E. Randox ..... Primerdesign ltd UK ...contract signatures
Hi karaen correct, I just thought that would sound a bit weird to say for some reason in the discussion .
The contract included training, and it was provided according to Ajan Reginald.
This is still available under his experience on LinkedIn:
Chief Operating Officer
Indirect Contract
Mar 2020 - Jan 2021 · 11 mos
"During the COVID-19 Pandemic, led the ~50 FTE NHS team deploying and training 90+ NHS hospitals at the peak of the pandemic to utilise rapid PCR tests for urgent patient and staff testing."
Trainers would have insisted on clean lab conditions.
The syllabus would have included that the IEC - Internal Extraction control - had been designed to detect a compromised sample and invalid result, requiring the sample to be re-analysed.
Definitely not the name of the game in busy labs.
Poidster hi , perhaps worth sending a message to Lynn Rees informing him of the other lab.
Ok Wilson..i see what you are getting at.
You met him in Brum if I recall correctly.
CS
https://uk.linkedin.com/in/andrew-birnie-11847baa
involved in co prep, hardly posts anywhere , what I'm driving at is the company feel it's important for this statement to be admissible as I'd presume our expert has came down on the side of viscocity which would not be helpful to us if you see what I mean.
Wilson - i understood that to be that dr birnie is on our side? so the judge is allowing is statement which will support our case
i still can't see the viscocity as being a problem for us
if they go down that route - it is deviating away from faulty product to user error - which twiggers will pounce on
Finally got round to reading this.
In synopsis the fundamental issue appears to be, is it user error or faulty tests.
I 100% know of at least one other lab, other than Portsmouth that had nowhere near a 10% failure rate. Using exsig/genesig.
Their view was that if staff were properly trained and signed off, then there were no issues with the test, at all, using either exsig or promate.
They did their own internal validation prior to going live with the test.
It passed with no issues reported and went into routine use, again with no issues and worked well.
Quote: "The test worked, and worked well, it was only if the user was a
d1 ckhead and didn't pipette properly that would cause issues" unquote
So thats at least 2 labs who reported no issues.
They would have used a variety of batch numbers as it was in use for months, so I don't think a 'bad batch
Is the issue either.
So, imo I still think its user error and not a flawed kit, how could it be if 2 other sites used it without issue.
Perhaps Twiggers could ask the claimants to explain that discrepancy?
I've said all along from yrs ago now that it's been a usability issue that is the root cause of the dispute, looks like i was right, properly helps explain why my posts disappeared so often.
This is still on DHSC to prove, that the test was flawed, which could be problematic given 2 sites used it without issues
Hi Kaeren .....the fda got it right ....American expert .....I remember sefton park .
And don't forget that Randox had to recall 750,000 of their tests because of fears they would be a danger to the public. This was in July 2020. Didn't stop them getting more repeat business from this corrupt government.
CS well the judge appears to place some relevance on it
"Further factual evidence
That leaves one further matter on which I have not been specifically addressed, namely the third statement of Dr. Birnie. I have read that statement. It does, I think, veer into areas of opinion, but that is a matter that I can take into account in terms of the weight of the evidence when it comes to trial. The principal reason for relying on that evidence is to refute the suggestion that the optimiser is a viscous liquid and it seems to me that at this stage before trial it is entirely proper that that issue, which the defendants say with some justification they had not anticipated having to address, should be addressed by the further short statement that they wish to rely on. I will give permission for them to do so at trial."
i certainly learnt new things , note the date on han****s letter. bunch of barstewards.
ditched for a test they didn't test , whilst claiming ours didn't work. 4.5 billion on tests fit for the bin.
anyone seen any litigation from uk govt ?
thought not. the bloody company had a couple of grand in its bank account and no expertise in assay development. yet here we are !
giz you might be complacent, i think it is a disgrace. they trialled innova in liverpool , they knew it didn't work. it was cheap !
It's hard not to be mightily frustrated and somewhat outraged reading lines such as ''they supplied £4.5Bn of tests that the US FDA suggested be 'destroyed by placing them in the trash'' at the same time as the DHSC goes to town trying to bankrupt Novacyt on very tenuous grounds to recover a mere fraction of what they tossed into the Innova bonfire.