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Points 19 and 41 makes us look a bit incompetent, and seems point 21,22 and 23 are essentially their case, but overall I'm fairly confident. Chatgpt 4-o when ran against terms of the original contract seems fairly positive
From Para 8. As to the case on robustness more generally, the defendants say that there is no contractual requirement of robustness which is itself a vague term. The IEC has been designed to detect a compromised sample and invalid result and, therefore, an "IEC failure" cannot evidence a flaw in the test kit. On the defendants' case, it follows that the claimant needs to show why the rate of invalid test results was the product of a flaw in the kits themselves and not an external factor.
++++
FWIW, this seems the crux:
'no contractual requirement of robustness'. - Robustness not defined (or used) in the contract.
From Para 4 - 'IFU advised users to only use tests where IEC (Internal Extraction Control) Cq result is less than 27'.
From Para 8 'The IEC has been designed to detect a compromised sample and invalid result and, therefore, an "IEC failure" cannot evidence a flaw in the test kit. On the defendants' case, it follows that the claimant needs to show why the rate of invalid test results was the product of a flaw in the kits themselves and not an external factor.'
+++
If the court agrees robustness is not a term that is applicable to the DHSC complaint, then ....the claimant needs to show why the rate of invalid test results was the product of a flaw in the kits themselves and not an external factor.
+++
I intend to reread and develop further understanding, but Para 8 seems important.
Some good points b2
Robustness is a term that hugger uses regularly..i suspect they have taken it from him
Fwiw..i think para 8 could be the key too...but for a different reason
I
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
Poidster hi , perhaps worth sending a message to Lynn Rees informing him of the other lab.
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.
Hi B2HS2L......he's not looking too well ...interesting post on roq R/E. Randox ..... Primerdesign ltd UK ...contract signatures
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.
"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.
They’d also have to wade through all the garbage too!
Hopefully they have Filtered these Chris. Like most of us have.
At my age life's too short !!
@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.
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!
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
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.
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
@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.
It would be good to know which of the DHSC labs had which of these instruments.
The IFU (dated 29.06.2020) contains the following :
"7.Real-Time PCR instruments
The exsig™ COVID-19 Direct (CE IVD) assay has been validated
with the following Real-Time PCR instruments:
• Applied Biosystems® 7500 Real-Time PCR System (software version 2.3)
• Roche® LightCycler 480 II (software version 1.5.1.62 SP3)
• Bio-Rad CFX Connect™ Real-Time PCR Detection System (Maestro™ software version 1.1)
• FluoroCycler® XT (FC XT 101, Bruker Hain Lifescience)
• QuantStudio 5 (ThermoFisher Scientific, QuantStudio Design & Analysis Software v 1.4.3)"
No mention of IT-IS Q16 / Q32 instruments here, but see
RNS - R&D Update
Mon, 27th Jul 2020
for Q16 & Q32 coverage.
+++
Which instrument was Portsmouth lab using?
If dhsc labs reporting processing failures were using the same instrument, that might have meaning, but you would expect an assay manufacturer to have switched on to that fact.
++++
Also see https://www.linkedin.com/in/cameron-littlefield-007678195/ to show continuous improvement capabilities on assays as at March 2021 and beyond.
+++
ref https://www.diagnocine.com/Content/Upload/Product/datasheets/Path-exsig-COVID-19%20Direct-CE-IFU%20Issue%201.0.pdf
re your
"....doing a root cause analysis of failure would be to immediately look to user error
before even considering a faulty test."
Might page 16 of the IFU be a problem for the labs reporting processing failures?
Para's 12.2, 12.3 and particularly cooling requirements of :
12.4 genesig® Easy RNA Internal extraction control (IEC) preparation
• The genesig® Easy RNA Internal extraction control (IEC) can be added during the sample
preparation to provide an RNA template control, detect PCR inhibition and confirm the integrity
of the PCR run.
• Precautions: This reagent should be handled with caution in a dedicated nucleic acid handling
area to prevent possible contamination.
• Upon receipt, the dried IEC can be stored at -20ºC for up to 18 months or the expiry date,
whichever occurs first.
• Using aseptic technique, resuspend the dried IEC in 1000µl of Template preparation buffer, mix
gently. Resuspended IEC is stable for up to six months when stored at -20ºC.
• Freeze/ thaw cycles should be minimised and not exceed 5 freeze/thaws. The reagent once
resuspended can be aliquoted into smaller volumes if required and stored at -20ºC.
Room for user error with IEC yes, but the IFU states what is required.
Hi poidster ....yes I hold a voting stake ..I don't short I play %...I'm very transparent in my position....until primerdesign ltd UK are vindicated ...the post is in no way aimed at yourself....primerdesign UK ltd are local and queen Alexandra cosham is my destination 6 days a week ....myself i have done well from primerdesign ltd UK ..shall I go sit in the box
@B2H,
Wow, thats a lot of questions 😳
Tbh, I suspect most routine hospitals used none of those analysers whilst using exsig/genesig.
This was what I was referring to in one of my previous posts regarding the testing protocol used by TVG.
Most routine labs would have used a manual preparation stage, then used the Q machines.
Tbh, these are questions for twigger to ask of DHSC.
Nova have and gave specific instructions for use of Exsig/genesig/ Q machines.
That was their method for accurate and reliable results.
Any variations from this would require interrogation by twiggers of DHSC.
This is the report I mentioned a few days that was co authored by Jo Martin (NHS )and Stephen Kidd (NHS) .In it they compared several rapid PCR systems that were on the market late 2020 to early 2021. If you look at page 12 it shows the validation of 483 samples in the NHS using Exsig Direct. Then if you scroll down to page 15 article 13 infers that this information regarding Exsig Direct comes from in service evaluation November 2020.
No wonder KC Twigger says the case is thoroughly bad.
https://www.researchgate.net/ publication/351535838_Meta-analysis_of_rapid-direct-to-PCR_assays_for_the_qualitive_detection_of_SARS-CoV-2
@EX
Fantastic info,
If I've read that correctly, how, just how can DHSC claim that its a faulty test ???!!@
This is a report done by the NHSs' own ppl fgs.
On what grounds, based on this report, could DHSC claim exsig/promate/Genesig isn't a robust test.
Its literally written in black & white that states that it is.
Usability and ease of use, is a world away from it being faulty.
I maintain, as I have always done, the test works. Its written in the NHS own report.
What on earth is this court case about?
I'm off to buy some more shares tomorrow, won't take many to get my average down, a lot.
@EX am I missing something here 😕
For the life of me I can't see what this dispute is about other than political shenanigans 🙄.
Honestly at a loss
Thanks for sharing 👍
Sedden worked for both !.