Member Info for scardey_cat

I feel dizzy, ODX just gone blue. Not seen that for ages.

Yes, AgentB, wouldn't surprise me if ODX (under NDA) hadn't been given the nod to get on with Avacta TT. All gone quiet on the ODX front.

PD testing validation protocol vs. Laboratory Test validation protocol.
Two protocols for essentially the same thing.
Does make you wonder if there is some sort of power play going on.

I was thinking about the same thing this morning benx4. If you look at the PD validation protocol last updated 4th May, it sounds like they've come out to defend themselves.

"This follows recent work at PHE Porton Down to support the development of this protocol which found there to be no discernible difference in performance when using frozen samples."

https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/protocol-for-evaluation-of-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens-lateral-flow-devices

Was this there before, does anybody know?

And a cheeky top-up by the Reverend? We've won the treble!

Also noting that the 'new' validation protocol includes usability assessment, whereas the PD validation didn't (I think I'm correct in saying that about PD).

https://health-family-contract-search.secure.force.com/servlet/servlet.FileDownload?retURL=%2Fapex%2FProSpend__CS_ContractPage&file=00P4J00000HBRuCUAX

See section 9: 'Usability questions'

"A client of mine has just been for a PCR as felt ill and did a positive LFT.. when he was at the test centre along with the PCR they also trialed a LFT! No brand but he confirmed it was AN test!"

A quick follow up on Robbo's post from yesterday.

There are two testing sites at Mcr Airport. One run by Collinson Group located in Terminal 1, purely related to 'Fit to Fly'.

There's another drive through centre for essential workers, people with symptoms or people who need a test re: upcoming dental treatment (this will be where Robbo's client had the LFT trial test). I considered booking a slot, but bailed out feeling a bit guilty about wasting NHS resources. If anybody has a genuine reason to attend or is unscrupulous enough to chose the 'Dental' option, it's easy to book a test online. You have the option of choosing your preferred drive through centre.

https://www.gov.uk/get-coronavirus-test

This Lab Test Validation Services tender closes today.
https://health-family-contract-search.secure.force.com/ProSpend__CS_ContractPage?SearchType=projects&uid=a074J000007Fu0iQAC&searchStr=&sortStr=Recently+Published&page=3&filters=&County=

Appendix 1 details the Technical Validation Protocol. In similar fashion to PD, it has 3 stages.
https://health-family-contract-search.secure.force.com/servlet/servlet.FileDownload?retURL=%2Fapex%2FProSpend__CS_ContractPage&file=00P4J00000HBRuCUAX

Below is one of the requirements for tests that complete all 3 stages
For Test Products that complete all evaluation stages, the following data will be produced:
CT value range Positive on Test
Product/positive on Comparator
Assay
Sensitivity (%)
<=25* (low)
25<30 (medium)
>=30 (high)
=CT that aligns with 1,000,000 copies/ml

I thought it interesting that Avacta used the exact same ct ranges in its clinical validation of Affidx. Perhaps they're following this new protocol.
https://avacta.com/lft-clinical-validation/

Sorry, first line should read <=25* (low)

This Lab Test Validation Services tender closes today.
https://health-family-contract-search.secure.force.com/ProSpend__CS_ContractPage?SearchType=projects&uid=a074J000007Fu0iQAC&searchStr=&sortStr=Recently+Published&page=3&filters=&County=

Appendix 1 details the Technical Validation Protocol. In similar fashion to PD, it has 3 stages.
https://health-family-contract-search.secure.force.com/servlet/servlet.FileDownload?retURL=%2Fapex%2FProSpend__CS_ContractPage&file=00P4J00000HBRuCUAX

Below is one of the requirements for tests that complete all 3 stages
For Test Products that complete all evaluation stages, the following data will be produced:
CT value range Positive on Test
Product/positive on Comparator
Assay
Sensitivity (%)
=25* (low)
25<30 (medium)
=30 (high)
=CT that aligns with 1,000,000 copies/ml

I thought it interesting that Avacta used the exact same ct ranges in its clinical validation of Affidx. Perhaps they're following this new protocol.
https://avacta.com/lft-clinical-validation/

I know a doctor that has a few in there. He tells me FUM is stretching his patient, sorry his patience.
On topic, there's quite a famous consultant called Mr James Bellringer. His main clinical interests might amuse you.

Just donning my lucky red jacket PL. When do I have to be there, yesterday or the day before?

Only 7? I counted about 12 on the Odious board alone.

At least she didn't call you Lee Harvey.

Might be quite telling how soon after MHRA sign-off, 'Add to Basket' appears on the Avacta website. Similarly, how soon Medusa offer an Avacta option.

RorkesDrift, does the quiz team know anything?

Interesting thought jdt. It's crossed my mind over the last few days, whether or not we're allowed to sell to Europe right now, regardless of MHRA rubber stamp. You've confirmed that in theory we could sell to Europe now, so why haven't Medusa, for example, got the product available on their website, with the proviso 'Not currently for sale in the UK'? Could be an admin thing, as you allure to, along the lines of why mess about with mixed signals for the sake of a few days...just wait for MHRA.

On the other hand, maybe AS is faced with a bit of a balancing act. If there's a reasonable/credible possibility of UK govt saying (after MHRA sign off), great we'll take everything you can make, it might explain why AS can't give Medusa the green light right now (or indeed advertise the test on it's own website), since he has to wait for that govt decision. If it's a positive from the govt, presumably Medusa would have to be put in a holding pattern, assuming the agreement between Avacta and Medusa gives Avacta priority on available manufactured goods, until such time as Avacta have surplus stock available (or, Medusa have their own manufactured stock available).

"AS said in the presentation that the only current UK client at any volume is the UK Gov, this would likely limit the appetite of any UK based manufacturers wanting to partner directly with Avacta"

Why would a manufacturer give two hoots about where Avacta sells the tests? They get paid anyway. Please explain.

Urgency, excitement, enthusiasm...precisely sums it up Cautious. Perhaps explainable by the fact they are finally in sight of having an Ag test to sell? The fact it was conducted in secret is maybe even more intriguing.

There was a young lady called Julie
Never with eye on her duties
With a taste for shoe
In red, white or blue
She would never be rushed unduly

A bit more dust for you enteleon.