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The problem is getting enough fresh positive samples for the analysis. Because most tests are done at home and there is a day or more delay between test and PCR validation, we need another arm of test and trace that knocks on the door of anyone testing positive and asks to take a larger volume of sample fluid from the infected person to transport to the testing lab.
Suitable targeting of "hotspots" would reduce the logistical problems.
Now with the prevalence in the population rising, would be the ideal time to instigate such a process.
If FDA uses fresh rather than frozen samples, it should be a breeze for AffiDX to get USA approval. Egg on face for Porton Down!
Porton Down, like most Public Sector organisations, is probably incapable of moving with the times. Tied up in bureaucracy and bogus processes, not having to worry about revenue and commercial viability.
Why on Earth have they treated sampling like they have, I have no idea. I could understand if it were the earliest days of the pandemic and there was a risk of releasing the virus into the general population. But it was already seeded on a global scale! They should’ve gotten their staff in to points of care to sample directly. Those live samples could’ve been assessed on the spot and follow-up PCR tests turned around in hours...
I’ve said before, this is a global problem that needs industrial solutions. The dithering at PD and dogmatically sticking to their procedures has likely cost lives.
Having said that to authorise a change now they would no doubt have to evaluate everyother test that failed i imagine.. So it would be a miracle to see a change in this stage of the game..
I wonder what is the standard pratice for research and approval of these labs across the world.
Why would you not use the real viral sample.(surely there's enough of it around in hospitals and testing stations) I know its probably a logistical nightmare but surely if you were to test something that was to be used by millions. Possibly billions of people you'd want to conduct the research in the most precise and realistic way possible..
I seem to remember that the FDA has led the way here too by requiring that samples used for validation of testing devices should be fresh rather than frozen. (Somebody posted a link to their process a while back.)
When the Huffington Post wrote about Avacta and criticised the Porton Down process, PD doubled down and issued a statement indicating that use of frozen samples made no material difference.
Rant time.
We have a misty eyed view that UK scientists are among the best in the world. Because Brits invented lots of sh*t, Bletchley park etc.
I'm sure some still are brilliant, but the procedures at PD were dumb. If you want to test a devise designed to work on live humans, test on live humans! It seems obvious to a lay person, but probably the "experts" at PD say, "we have always tested with frozen samples", so are stuck in their ways, = bad science.
Curious but lazy scientists caused this pandemic by fuc*ing around with bat viruses, if you think that a bold statment, google "the origin of covid" and look for thebulletin.org.
complicated but shockingly fascinating read.
If you liked that, read the Piper alpha Wikipedia page on another story of how lazy or bad practice with paperwork lead to 160 odd people being burned alive.
I think the frozen sample problems may be more of an issue with the spike protein itself not the affimer.
Pl linked this Lionex S1 spike ag test a while ago.
https://lionex.de/wp-content/uploads/2021/01/COVID-19-Ag-Schnelltest_Gebrauchsanweisung-rev.-6.0_Booklet-EN_DE.pdf
From the IFU
General Notes
• The test works best with fresh samples. Swabs specimens should be tested as soon as possible after collection. Use freshly collected specimens for best test performance.
• Avoid freezing and thawing specimens.
yes exactly, they allow an alternative validation process if equivalent to phase 3a isn't it? Also on self-test it is about doing an appropriate self use study and with that submitting for self use via the MHRA. It has been suggested on the boards that they have done such a study through MedUsa at Stockport with two of our intrepid holders trying to get in as subjects and although too late were able to mine some useful info off the Medusa rep
Can someone kindly remind me why AVCT suggested AffiDX was not suited for the PD approval process, and what this therefore means for the potential future for AffiDX? How would it get approval for self-use? I'm missing something here.