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Good spot on the article. Biosecurity is a genuine concern on POC tests, including for Avacta. In case you haven’t seen it, the lead on CONDOR, Rick Body, has an enlightening spiel on this here in the q and a:
https://youtu.be/oApbjEs0es4
He says that saliva is a great sample to use, but some manufacturers hadn’t yet fully addressed biosecurity for POC options. He talks about the need to put a blocker into a buffer solution. There is a chance this relates to Avacta. He makes the good point that if you mix in an open tube some of the solution is aerosolised, ie creates fine airborne particles. You’d imagine that a lot of thought could also be going into testing protocol and component engineering solutions to minimise transmission risk.
Essentially, for POC tests - not at home - you have a trained professional do it in a location that may also be shared with others over time. So there could be some transmission risk, particularly to this professional. We are not yet talking about approvals for consumer tests aka ‘do it at home and bin the test’ options.
As to blocking in the buffer, as I understand it, typically the signalling coloured beads coated in Affimers that bind the virus and then the signal line to give the test result would generally be on the paper strip in the conjugate pad, not in the buffer solution. So some element of a rethink may be ongoing here - maybe additional Affimers binding a different part of the spike in the buffer solution? This is just guessing as to the details of course, but the big picture does seem to be that this biosecurity step has likely added some time - a couple weeks maybe? - to the timeline.
As I’ve said before, given the potential huge positive impact of these tests I think there’s no way they’ll let this be a show-stopper. If i am wrong on that, then I quite agree it would seem idiotic to worry so much about virus in the testing fluids during the <15 minutes to run a test, when the same virus is being shed in greater quantities for a much longer time by asymptomatic carriers who you need the screening test to detect! I suspect and hope they are just quite sensibly being asked to take a bit more time to reduce biosecurity risks from the testing process to ALARP before getting approval and going on to produce them in the 100,000,000’s (or billions) required. When Avacta nail this it will further increase the test quality by making it safer.
Could this be another line of business as well - licensing neutralising Affimers for everyone else’s buffer solutions? Or is there a simpler way to deactivate the virus without breaking the test?
It helps Chiron but what is so mindless is that witholding a test on infecting reasons due to spillage is saying it is OK for a positive covid case to walk around and infect everyone! Screw loose springs to mind. The majority of tests will be negative it is covid carriers that need isolating not a used test!.
This really is a non-issue for a POC test. In the home one would expectorate into a receiver that clips shut and the test is run in a sealed cassette with a window visible for result. This can be discarded into household waste. And yes that's fine. We don't ask all COVID+ patients to seal every tissue they sneeze/cough into at home via a biohazard bag. This is not a transmission route of concern for many reasons. Outside these settings so called universal precautions would apply.
The article is weak and strikes me more as disgruntlement for being left out of discussions than any plausible science.
There are millions of biohazards discarded into household waste daily without concern- BM blood sticks diabetics use, pregnancy tests, condoms etc!
The beauty of a POC rapid test is not having to ship samples around to a centralised lab, as this is where the greatest risk occurs.
Hope this helps.
GLA
Chiron
It’s certainly a consideration but it doesn’t really feel like it should be a show-stopper does it ?..... especially given that our economy, our health and our whole way of life is at stake.
Or just double bag it and wait 3 days before normal waste disposal, that’s the current govt advice for the infected.
With a qr code attached and comes in a sealable capsule, which you can dispose of, in a sharps like box at your local gp, supermarket etc for incineration. Etc
A miss aimed spit maybe but I do think they should market a cheaper non-buffer version for home/isolatede use only.
@Scarabbeatle, I think that a few affimers have acted as a blocker to stop the virus entering human cells through the Ace2 so not actually a neutraliser. I could be wrong. Happy to be corrected
Yes Scarrabeattle, that’s what we believe some of Avacta’s reagents will do. Other things that spring to mind;
I) the person taking the test could do this behind a screen being observed by the person in charge of the test
2) the person in charge of the test could wear a face shield
3) upon completion of the test the person who took the test could just drop the strip into a ‘bucket’ of sanitising solution all to be collected by a designated staff member, wearing suitable PPE, at the end of the session for bulk collection by licenced removals.
Mmmm..... I’m winging this a bit !! I think I might call upon @Ophidian to check my offering !!
I thought the affirmers also acted as an neutraliseing agent, so by using the LFD the affirmers would neutralise any virus while on the LFD. Or am I missing somthing?
Questions how safe it is to sample outside the lab.... I guess this ties in with Orphidians thoughts about the delay. Sure we will figure it out.
https://www.thecourier.co.uk/fp/news/local/dundee/1488319/tayside-professor-raises-safety-and-accuracy-fears-over-incoming-90-minute-coronavirus-tests/
“At the moment, all testing for Covid-19 needs to be done in containment laboratories such as those we have in Ninewells Hospital, because samples like swabs or saliva could be infectious.
“It is not considered safe for us to work outside of the labs with saliva or swabs.
“So the UK Government needs to explain how they would expect an untrained member of staff to work with saliva to deliver a test and how this could be done safely.