The next focusIR Investor Webinar takes places on 14th May with guest speakers from Blue Whale Growth Fund, Taseko Mines, Kavango Resources and CQS Natural Resources fund. Please register here.
Also lab/centralised testing is dependent on swab sampling which is not reliable.
They are also still focused on testing people with symptoms (who should isolate anyway) and missing all the asymptomatic spreaders.
Am i losing the plot now.
Everybody is trying to get a test - saying they want to get back to work/school.
So if they have symptoms and they test negative, they are going to go back to work/school? I. Madness, why is this not being called out - with the current testing/swab sampling there is the possibility of false negatives. f you have been exposed, but have no symptoms they would not trust a negative result
All of this testing is pointless. They have capacity so they are expected to use it. There is no real strategy.
They need to have sampling that can be trusted - saliva to test infectivity And get some sense.
The bad news - rumours that we have only just ordered tooling (£500,000 cost) for the plastic components of the LFT
The good news - Since it was known that this test was likely to be subcontracted to multiple manufacturers, I would be very surprised if it was not designed in the most generic format, including generic (off the shelf) plastic components/cassettes for which a premium is paid.
The rumour that they are buying their own, very expensive, high throughput tooling suggests that they are very confident of high demand and sales.
Nothing here about a Danaher lateral flow test. I wonder where that is?
Copied from gov website- after signing up for antibody test, wait for a text message.....
You’ll need to wait for a text message or email inviting you to order a test. You may get this invitation in a few days but it can take up to 3 months.
In Europe there are a small number of IVDs which require a notified body to CE mark the products. For the rest, including Covid) the IVD directive requirements are different for professional use and consumer use.
The ‘manufacturer’ has to comply with the requirements of the directive and for a professional product can then raise a declaration of conformity and CE the product themselves. For consumer products/self test they need to comply with the requirements of the directive as above, get a separate consumer trial to ensure that lay people can use the test and also interpret the result, raise a declaration of conformity, then get a Notified Body to review their test, technical documentation and systems.
That is why LFTs are being sold for professional use only.
You have to define the critical materials/ suppliers and validate the design. Tech transfer, you would be tweaking process to suit manufacturing equipment and then you validate the process. If you want to make subsequent changes to suppliers, you would have to consider the impact on design and performance, and the extent of validation and claims support which would be necessary.
Interesting they have dollar option. I doubt if they will be trying to get the saliva protein test approved in US - a proper regulatory review. Must be expecting Avacta Fda approval.
Cytiva iwas the nonradioactve, life science arm of Amersham. Amersham also bought out Whatman, which is why Citiva are involved/experts in lateral flow.
There has only ever been talk of tech transfer, not ongoing development. Materials and suppliers will all have been identified, any changes would be significant design change.
More info on Medusa saliva protein test (antibody)
They say professional use only (healthcare professional should be present), therefore they can self declare for CE marking.
IFU on the website.
This talks about the test and the limitations, and a proper professional should understand that antibodies may of may not be present, may or may not mean current infection.
Pretty crap
Updates to website, more links to shop, including Consumer - Avacta. Currently not available, pending approval.
Things are happening in the background
Very simplistically
- Elisa and Bams start with Affimer attached to a substrate - Elisa - 96 cell plate, Bams (bead assisted) magnetised beads. The antigen is added/becomes linked then surplus washed away through incubation/ washing steps. The bead assisted process allows very efficient washing/ immobilising the beads/ switching magnet on/off for high throughput.
Elisa is then read with addition of detection system/ washing process again for colourimetric of fluorimetric analysis.
Bams - the detection system is mass spectrometry.
Sona Nanotech and GE Healthcare (Cytiva) are named as one of their case studies/Covid 19 Global Consortium
Fair number of associated partners - Sona Nanotech, Abingdon Health, Mologic.
BBI is not on there but they have their own software company
Condor is looking to verify testing in a real use setting, so in clinical laboratories, and perhaps also with laypersons because they want to recommend Government use/endorsement.
Clinical validation at LSTM and the additional Lay person trials or user trials are Avacta trials to support their regulatory submission/technical files to support CE Marking.
After clinical validation, and they have completed the technical documentation, and the other obligations of being a medical device manufacturer (possibly through meeting ISO13485) Avacta can self declare compliance and CE mark for professional use.
Then after they have completed user trials, they would have to submit information to a notified body to verify compliance to CE mark for home use/self test.
They will also be doing user trials/lay person tests. This will be a requirement of home use, rather than professional testing. This does not need to wait for clinical validation because it is more about people being able to use it correctly and understanding how to interpret results.
Apparently trying to get Covid samples so they can train sniffer dogs. Could be interesting at the airport.
I think getting the test out may be a priority (although I despair how PHE seems to want to keep everything centralised and under their control, however busy they are), but I also think that it has been recognised that the Government has been left with egg on its face before. It cannot get this wrong, and logistically our manufacturing capacity in the UK is nowhere near what we need
I posted against BBI tweet info, and it may have been lost in translation. They have updated their LFT app
Cut and paste
A new template has been released by the FDA to assist manufacturers gather sufficient data for their emergency use authorisation submissions for molecular and antigen diagnostic COVID-19 tests in non-laboratory use.
Note - molecular and antigen diagnostic tests. They are not interested in antibody tests
Cut and paste
A new template has been released by the FDA to assist manufacturers gather sufficient data for their emergency use authorisation submissions for molecular and antigen diagnostic COVID-19 tests in non-laboratory use.
Note - molecular and antigen diagnostic tests. They are not interested in antibody tests