RE: DHSC disputeToday 16:06
Hi,
Yes, got a bit fed up with my posts just being deleted all the time, probably like this one will lol.
To shed a little light on a few Qs.
Also bear in mind the situation at the time regards testing, 10,000s of additional samples being sent for testing and no off the shelf solution available (this was in addition to normal workload)
User error is highly likely in a busy diagnostics lab.
The sample volumes are in ųL which is 1 millionth of a litre just to give context.
So unless you have pin point accuracy, each and every time, results can be inaccurate, esp with PCR testing, so when you have a batch of 100 samples that need processing and are all urgent, you can imagine mistakes were made and possibly carry over from samples to sample.
PCR testing demands scrupulously clean and uncontaminated environment.
So yes user error in a live environment is highly likely.
The tests are unintelligent, it looks for a piece of RNA/DNA if it finds it in sufficient quantities then it flags as positive else negative. That's basically it.
Exsig was using existing, well proven methodologies, they were just looking for a different target (I've simplified this obvs but fundamentally that's it)
It passed TVG testing
There were regular conf calls with TVG and live sites (would be useful to get the minutes of those meetings @novacyt) where any issues were discussed.
It's subsequently passed CDTA testing
I think the TVG initial testing protocol was flawed and didn't replicate a 'real world usage' scenario, which is DHSC problem not nova.
So I'm still at a loss having read the DHSC case for the basis of their claim, feels like they are rewriting history to me.
Finally, and this is what really, REALLY sticks in my craw.
After exsig was distributed & staff complained it was too slow, Nova bust their b***s to develop promate, which resolved the usability issues, then coprep too.
Bear in mind we were still in the midst of the pandemic at this point (and still are by the way, just now noone cares)
So, as I see it, the position is as follows
Exsig developed super quick. ✔️
Sent for TVG validation and approval. ✔️
TVG passed Exsig as fit for purpose, ✔️
Exsig distributed at agreed volume ✔️
Issues identifying with usability on a live environment ✔️
Promate developed problem solved ✔️
DHSC refusing to pay for Exsig ??
They tested it , approved it distributed it,
Stalemate.
Hence all the pallets of Exsig hanging around labs for weeks.
So nova pulled out all stops to address a usability issue, DHSC screws them over. F.O.
also,
Another thing to bear in kind is that Promate, which everyone says is fine,
IS exsig, the exact same test, they have just removed some of the preparation steps by clever science.
Make this, make sense to be because as it stands it doesn't.
As you were
P