Member Info for Fardistanthills

Carclo mentioned earlier in this thread. Presumably they and their subcontractors are amongst the 100s of companies involved in the much vaunted Moonshot.

From CARs 17/8 Trading Update:

The Technical Plastics business benefited from robust demand for products relating to Covid-19 testing, which partially offset a reduction in demand for other products in both the medical diagnostics and industrial sectors

Related also to the Detail thread. I think it interesting that whenever, or almost whenever (!), AS mentions progress with the LFT he describes it as the test we are developing with Cytiva. From my experience. which I stress is not related to test strips, I can appreciate how crucial to performance the membrane composition and placing of reagents must be. I think we may underestimate Cytiva's role. In a previous post wondered whether they will in fact be manufacturing the test membrane strips, which the likes of BBI will then take in for the final assembly of the test devices? I might be barking up the wrong tree so just speculation on my part.

Agree about the excellence of Cytiva PL75. Albeit some years ago now I worked in Laboratories that used a lot of their membrane products and they know what they are doing.

To run with Ophidian's excellent analogy, but twisting it a bit and probably not putting it terribly well, could it be the punter goes into the restaurant, looks at the menu, cannot decide, makes an tentative decision, enthuses endlessly about the about prowess of the chef, then makes a last minute change to his order?

Thanks Trek, not only not knowledgeable in this area but also old, forgetful with degenerating brain cells - there has indeed been RNS reference to the use of ELISA validation.

I agree - though "non-specialist scientist with a dangerous tiny amount of knowledge in the field" sums me up too. One further thought though is that in the field of sampling and analysis there is sometimes the need or possibility of using primary and secondary standards. I would have thought, as you imply, since BAMS and the upcoming AVCT LFD are both based on a saliva sample, whereas PCR uses nasal throat swabbing, then BAMS would become the better albeit secondary standard for the saliva POC/home use LFD?

Fantastic RNS. To my mind confirms everything. Why would the UK's pre-eminent LFD manufacturer sign up to a dud. So many posts already today and I'm probably repeating what has already been said - probably many times! But for me this bit is fantastically reassuring

Authorities around the world are now looking to carry-out frequent mass testing to identify THE MOST INFECTIOUS PEOPLE promptly in order to reduce infection rates and combat the coronavirus pandemic.

It seems now well understood that the most infectious part of Covid is within the first 2 or 3 asymptomatic days. after which some people remain asymptomatic - children in particular - and others go on to develop the full range of mild to severe symptoms. For the AVCT Cytiva strip to be picking this up indicates very impressive performance.

B2HS2L, I am guessing here but I think Cytiva will manufacture the test strips, the membranes , which will be shipped to BBI who will produce the final device?

Eric - I would think Cytiva are capable of producing pilot batches of lfds. But I do not know if these would be accepted as part of the EUA process.

The role of Cytiva seems to cause some confusion. Are they a manufacturer, just a developer of test papers, one of several manufacturers or what? My understanding is that Cytiva have developed and will be manufacturing the 'paper' - the lateral flow test strip - with BBI then assembling and completing the whole test kit for onward distribution - by Medussa and perhaps others.

Cytiva are specialists in the development and manufacture of test strips. Development and selection of the right assay membrane / test paper for use with a set of reagents - in our case the affimers, etc developed and supplied by Activa - is a highly skilled task and I suspect Cytiva are one of the best.

Anyone who has worked in a UK laboratory will be familiar with Whatman papers and membranes - for chromatography for example. Whatman and Amersham International got taken over by GE Healthcare, and they are both now part of Cytiva. Whatman has a fascinating history. Founded in 1740 in Maidstone by papermaker James Whatman the Elder (1702–1759) the inventor of wove paper and still going strong as an integral part of Cytiva! I am digressing a bit! This gives a good idea of what they get up to :

hTTps://cdn.cytivalifesciences.com/dmm3bwsv3/AssetStream.aspx?mediaformatid=10061&destinationid=10016&assetid=16472

So my guess is that Cytiva will produce all the test strips shipping them to whoever - BBI and potentially others - for what I would call the final assembly, using the Ginolis machines as Canute40 has mentioned:

hTTps://www.youtube.com/watch?v=4BHBRRhf1fw

I may be wrong of course, but I suspect that Cytiva having done the vital intermediary step of optimising the lateral flow paper will be retained as the sole supplier of these papers - I wouldn't be surprised if Cytiva have their own IPR invested in the assay strip they have selected for Activa. I should think production under single control will be considered essential, in order to achieve product uniformity, assurance and acceptance.

Final assembly of the lfd and packaging with reagent, spit tube, etc is probably the easy bit?

Hope this helps, fdh

The people driving testing in this country are the academics at PHE, the CMO and their ilk - they have a "bad test is worse than no test" mentality. PCR is to them proven. It works in theory and they have never been interested in what works in practice.

Some very interesting points made below - my thanks. But I think something is confusing me - and I'm not sure what. Maybe its difference between LOD and analytical sensitivity as opposed to clinical?

PL: "I hope they publish the Ct figures and then communicate this well, something like 75% sensitivity overall, but 98% in the peak infectious period."
Absolutely right.
You need to PM AS and get him to do one of his very good explanatory guides focussing just on this.

Perhaps this will free up some manufacturing capacity?

The article in todays D Tel is essentially an interview with Sir John Bell about antibodies, immunity and testing and and this is what he had to say about rapid testing:-

CLOSE TO A BREAKTHROUGH
So far every ten minute ‘lateral flow test’ (where finger prick blood is fed through a pregnancy-style cassette at home) tested by Public Health England (PHE) has been found wanting. The only validated options are so-called ELISA tests, where blood is taken intravenously by a medical professional and then analysed in a lab, which of course takes time.
However, Sir John believes his team are on the brink of a breakthrough.
Last week PHE launched a study into the effectiveness of a number of home testing kits, including one developed by the Rapid Test Consortium, involving Oxford University and four UK manufacturers: BBI Solutions, Abingdon Health, CIGA Healthcare and Omega Diagnostics. The results are due in late summer.
“We know the analytical quality is good,” Sir John said.
“All we need is the science that supports the notion that having antibodies is protection. We’re doing those experiments at the moment, and we’re doing them alongside T-cell studies.
“All I can say is we hope and think this Rapid Test Consortium test is the real deal, a game changer, if you like,” Sir John said.
“I foresee an antibody test appearing before the end of the year, and this may well be the one we’ve been waiting for."

NOTE he says PHE last week launched "a study into the effectiveness of A NUMBER OF HOME TESTING KITS, including one developed by the Rapid Test Consortium" So presumably this might include and does not exclude Avacta's test?

Rapid testing. LFD - POC, etc - is going to be a huge market with lots of players. AVCT are clearly aiming for a gold standard product. Crucial to this to my mind is high specificity, which I imagine the use of Affimers will ensure. So I surely the AVCT product will allow pricing to be set at something of a premium?

Some concerns seems to have recently arisen along the lines “Cytiva will not be manufacturing our test. I thought they would be manufacturing for US and other British manufacturers for ROW. But this presentation again only mentioned British manufacturing.”
This is my first post on LSE so don’t shoot me down. I am long since retired but used to work in an industry that used all sorts of laboratory test and analytical equipment. So as I am familiar with some of what Cytiva does I am posting here to see if I can help clear up what I think may be a misunderstanding. Though I should stress the maybe!
Cytiva owns what were originally two highly regarded UK companies Whatman and Amersham International both of which were taken over by GE Healthcare, now Cytiva. I believe Whatman and what remains of Amersham still manufacture in the UK – at Amersham? Whatman are I suspect still pre-eminent in the development manufacture and supply of high performance laboratory filters and membranes, chromatography papers, test papers, etc, etc, including diagnostic strips. I believe it will have been Whatman’s expertise in the testing, development and refinement of the diagnostic membrane strips that will have drawn Avacta into partnership with Cytiva.
The two key bits that have to be put together are Avacta's Affimer reagents and someone with membrane knowhow - Whatman. So perhaps the reference to British manufacturing may simply be a reference to diagnostic strip production at Cytiva’s / Whatman facility at Amersham? Perhaps Whatman will end up supplying membrane strips to multiple lateral flow device manufacturers at various locations worldwide? End device manufacture is presumably the easy bit!
This gives a feel for the complexity of it all and implies that Cytiva’s strength lies in its membrane expertise:
https://cdn.gelifesciences.com/dmm3bwsv3/AssetStream.aspx?mediaformatid=10061&destinationid=10016&assetid=16472