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No Instrument Needed!

E: A connection is helpful

Fast, single-step method with visual readout.

Scientists at Oxford University have developed a 30 min RT-LAMP method. It only requires PCR tubes and a heater. The readout is a simple colour change. 

http://www.ox.ac.uk/news/2020-03-18-oxford-scientists-develop-rapid-testing-technology-covid-19

https://edition.cnn.com/videos/health/2020/03/23/uk-coronavirus-outbreak-pandemic-covid-19-test-oxford-university-npw-pkg-intl-ldn-vpx.cnn

It has been validated using 16 clinical samples (extracted RNA, 8 positive, 8 negative) and showed 100% concordance with RT-PCR.

Experiments with synthetic RNA, show that the test will perform well without the need for RNA extraction. The RT-LAMP chemistry is more sensitive than RT-PCR  and is able to detect 80 virus particles per ml (compared to ~300 copies per ml).

A larger scale validation study of the test without RNA extraction is being planned in Oxford.

How quickly could this be deployed and what are the dependencies?

The 'No Instrument Needed' test could be deployed as fast as the reagents can be procured and consumable kits assembled. The rate limiting step with all other POC tests is the manufacture of complex electronic instrumentation, which is slow to ramp up. This method only needs a heat source, which are already very widely available.

The simplicity of the test also makes it suitable for home use mass testing.

What is the likely production volume?

The Oxford team has secured funding to produce 5000 tests. With government support and a manufacturing partner hundreds of thousands to millions could be produced in a timescale of a few months.

What are the risks and barriers to using this at scale?

The main barrier scaling up point of care COVID testing is common to all solutions - that is training sufficient healthcare workers to safely take swab samples from patients and providing them with sufficient PPE.

A home based self-test would eliminate this problem. However there are uncertainties around quality of samples that people can take themselves and there are report of high false negative rates even with swabs taken by professionals.

Who are you already partnering with on this?

Oxford University is partnering with:

Oxford University Hospitals Trust

Oxford Suzhou Centre for Advanced Research

Shenzhen Luohou People’s Hospital

Oxford Mestar Ltd (Oxford University spinout company, ISO 13485 certified for IVD manufacturing)

edited on Apr 13, 2020 by Simon Bayly
Simon Bayly

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Doris-Ann Williams Apr 13, 2020

Has this technology been used for other analytes or is this a completely novel solution in response to the crisis?

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Simon Bayly Apr 13, 2020

Hi Doris-Ann, RT-LAMP is a well known technique and is the basis of some commercial diagnostic tests. Wei Huang and Zhanfeng Cui developed the primers for SARS-CoV-2 and streamlined the process to combine RT and LAMP steps in one-pot at one temperature.

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Simon Bayly Apr 15, 2020

Hi Doris, I am rather surprised and disappointed that you have classified this proposal as status 'E' - outside scope, and therefore will not receive expert review. I understand that strictly speakingthe technology is not 'desktop PCR equipment', however it solves the same problem and has the advantage of being rapidly scaleable by removing the need for costly and slow to manufacture instrumentation.

Furthermore, the status is not consistent with the status given to similar answers to this challenge - "rt-LAMP Assay" (similar technology, no instrument required) is categorised A, and "CRISPR DETECTOR lateral flow field diagnostic" (does not require an instrument) is categorised B.

I would be grateful if you would reconsider the status awarded to this idea as I believe that it deserves expert review.

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Simon Bayly Apr 17, 2020

I would be very grateful if the status of this idea could be reconsidered.

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Jeff Roix Apr 13, 2020

Simon,
Fantastic. Just curious input my reading, and no need to take time to reply: will reagent production possibly become limiting or needing long-range supply chain support? I assume these are gold-labeled (oligo) detection reagents: are there UK-domiciled or assured supply chain solutions for scale-up production?

Also: specimen tracking and integrating QC/QA results into healthcare reporting databases may be more intrinsically more challenging with great open-lab / field diagnostics like this. Do you have any partners to assist with barcoding and lite informatics solutions?

Users tagged:

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Simon Bayly Apr 14, 2020

Hi Jeff, many thanks for making those important points. We are looking at test performance using reagents from different suppliers, to keep supply chain flexible. However a dedicated reagent production in the UK would be ideal. If you have any ideas on this or the specimen tracking part then please let us know.

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Jan Rogers Apr 13, 2020

We have a sample prep that is very simple which can be taken at home and potentially inactivates the sample (currently being tested). The sample prep can be used with saliva or swab - a saliva sample would be easier to self collect. We have just posted on the RNA extraction - Arcis RNA extraction. We have also previoulsy shown good compatibility with LAMP assays

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Simon Bayly Apr 14, 2020

Hi Jan, many thanks for your suggestion. Does the Arcis reagent contain pH buffer? We have discovered that they can interfere with the readout colour change.

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Jan Rogers Apr 14, 2020

The reagents are not buffered, we have previously used isothermal amplification for bacterial diagnostic sucessfully. Hopefully there would be no interference

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Kyle Beacham Apr 14, 2020

Status label added: E

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Simon Bayly Apr 14, 2020

Hi Kyle, what does this mean?

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Kyle Beacham Apr 14, 2020

Hi Simon, information on status labels can be found here: https://testingmethods.crowdicity.com/hubbub/communitypage/108570 Thank you for your contribution.

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Simon Bayly Apr 14, 2020

Hi Kyle, thanks for the info. It's rather disappointing that you are sticking to a strict interpretation of 'desktop PCR equipment' when our technology could very rapidly speed up POC testing by removing the need for costly and slow to manufacture instrumentation.

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Kyle Beacham Apr 14, 2020

Hi Simon, I work for the company supplying the platform for this campaign - so unfortunately I cannot personally assist in connecting you with the appropriate group for further discussion. I am aware that communication is underway and someone will certainly be in touch over the next few days. Thank you.

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Simon Bayly Apr 14, 2020

Hi Kyle, did you make the decision to categorise this submission as 'E' yourself or are you just responsible for adding the label?

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Kyle Beacham Apr 14, 2020

Hi Simon, no - I do not have a decision in what status labels an idea receives. I am only responsible for adding the label.

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Simon Bayly Apr 14, 2020

Thanks Kyle, I would be grateful if you could put me in touch with the person responsible for deciding the category.

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Kyle Beacham Apr 14, 2020

No problem, perhaps Doris could help point you to the right person for further discussion.

Users tagged:

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Simon Bayly Apr 15, 2020

Many thanks Kyle

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Elen Withycombe Apr 14, 2020

Hi Simon, Really interesting technology. Just wondering if it possible to label two of the primers and link up with a LFA for assay read out?
https://testingmethods.crowdicity.com/post/3167380

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Simon Bayly Apr 14, 2020

Hi Elen, I think that would be possible. What are the advantages of using LFA rather than colour change as a readout?

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Elen Withycombe Apr 15, 2020

Hi Simon, I was just thinking that the LFA would offer an alternative read out, if sourcing of components to meet the demand became an issue. The LFA is a familiar format to the majority of end users and could therefore also be considered for home testing. If of interest, it would also be possible to pair the LFA with our App, enabling results to be recorded immediately alongside test location and automatically uploaded to a central/clinical hub.

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Andrew Burrows Apr 15, 2020

As with many currently considered testing methods the key to success in terms of speed of testing, accuracy of the result and reporting is for the government to source the work through the many clinically trained personnel in the private sector, particularly professional Occupational Health Providers and thus taking the workload off the NHS and supporting their staff.

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Eswar Ramalingam Apr 16, 2020

1) This is an excellent test for COVID19 detection in primary and secondary health centres in resource deprived regions of Africa, Asia and Latin America.
2) The simplicity of the test results hide the complexity of the technology underpinning it.
3) I expect the tests to be multiplexed for community screening in developing economies.
4) the technical personnel in small towns of developing economies may not have the same technical expertise of the kit developers.
5) To prevent visual fatigue of technicians when doing multiplexing in vast numbers, or those with colour blindness and to prevent confirmation bias, it is imperative that the test results be captured by a smart phone camera app which recognizes the colour change without bias.
6) there is a smart phone camera app based testing protocol for urinalysis/ www.healthy.io.
7) Perhaps an app with hyperspectral imaging and machine learning algorithm embedded inside will get was rly benefit technicians to score the tests without visual bias.
8)The RT enzyme has to have the same price or lower price as Taq Polymerase.
9)Need to see whether the RT enzyme manufacturer will provide enzyme at a low price-given that it is a pandemic and requires public-private co-operation.
10) Need to convince governments worldwide that this test protocol enables community monitoring to have an idea of infection cluster expansion and shrinkage in cities and towns and villages based on underlying GIS data.

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Eswar Ramalingam Apr 16, 2020

This is the template for the smartphone camera based app testing protocol-https://healthy.io/urinalysis-products/

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Eswar Ramalingam Apr 16, 2020

The test can also be adopted by commonwealth nations if UK approves adopts it. This will cover vast swathes of Asia and Africa.

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Jo Martin Apr 18, 2020

May not be directly pertinent to the specific call, but is interesting! Presume being taken through the CE/FDA development route?

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Simon Bayly Apr 18, 2020

Hi Jo, many thanks for responding. The results of the (no RNA extraction step) validation study now underway in Oxford should allow us to obtain CE for professional use.

Please could you explain why you think this solution is not pertinent to this call to add "testing capacity through reliable and standards based testing at the point of care". The test would be simple to implement at point of care, precisely because it does not require an instrument.

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Jo Martin Apr 18, 2020

Relevant at this stage, that’s all...needs further development to become a ‘desktop PCR’..looking forward to seeing it come though the validation and CE process and will keep eyes peeled for the product!

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Luke Wainwright Apr 20, 2020

Dear Simon,

Many thanks for sharing the information above regarding a RT-LAMP method for SARS-CoV-2. Further to Jo's comments above, this does not fall within the remit of the current testing methods campaign, but is nevertheless of interest to the wider COVID-response, therefore please refer to the following webpage:

https://www.gov.uk/guidance/help-the-governme...esting-capacity

Best wishes,
Luke

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Simon Bayly Apr 20, 2020

Hi Luke,
Thank you for your message. I still have not received a good explanation of how this testing method is out of remit when it has the potential to add testing capacity at point of care and to be able to scale up very quickly. Furthermore 'CRISPR DETECTOR lateral flow field diagnostic' has been deemed within remit and operationally it is a very similar proposition (ie not a desktop PCR).
Also, the link you provided is 'page not found'.

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Luke Wainwright Apr 20, 2020

Hi Simon,
My apologies for the faulty link, does the following work -
https://www.gov.uk/coronavirus-testing

With regard to remit, I'll chase with colleagues.

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Bev Matthews Apr 21, 2020

The idea has been progressed to the next milestone.

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Simon Bayly Apr 26, 2020

A peer-reviewed paper on this method has just been published:
https://sfamjournals.onlinelibrary.wiley.com/...1751-7915.13586

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Luke Wainwright 11 months ago

Hi Simon,

I do apologise that it's taken so long to get back to you with a satisfactory update. Since we last spoke, I have shared your submission directly with the Viral Detection Test Advisory Group (VTAG), who have assessed your testing method and updated their records accordingly. The verdict is that, at present, the solution is too early stage to progress. As and when your testing solution matures, please get back in touch.

Good luck!

With kind regards,

Luke

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Simon Bayly 11 months ago

Hi Luke,
Thank you for sharing the idea with VTAG. The feedback is not particularly informative or actionable. What does 'when your testing solution matures' mean? My understanding was that through participating in this platform we would be connected to people who can help us progress the technology.

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Luke Wainwright 11 months ago

The idea has been progressed to the next milestone.

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Simon Bayly 11 months ago

We now have clinical data showing that the test works direct from swab samples.

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Simon Bayly 10 months ago

Oxford University has launched a spinout company - Oxsed Ltd - to bring this technology to market. CE registration is expected very soon.
https://www.ox.ac.uk/news/2020-07-08-oxford-s...d-19-virus-test
www.oxsed.com

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