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One tube COVID kit that does it all in less than 1 hour (POC) or 2 hours (96 plate)

D1: Path Lab Bulletin
D3: Catalogue of Resources

Complete testing kit that contains swabs, specimen tubes, PCR tubes, proprietary enzymes and reagents. For COVID testing includes positive and negative controls.

Detection limit 200 copies/ml.

Works on several proprietary PCR machines and also on open technology PCR machine.

Have you validated this method, if so, how and what were the results of the validation?​

Not personally. We have access to full COVID kit manufactured in China, CE marked that uses one tube technology to process the sample. The kit contains proprietary sample preparation reagent and it takes approximately 10 minutes to prepare a test tube that then goes into real PCR machine. Kit is compatible with several proprietary machines and also Open technology Per machine that the sam manufacturer can provide.

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

Time from order to delivery is currently 20 days although for larger orders it could potentially be shortened to 14. Price is CIT and it will be delivered to UK customs (probably London). Customs duties and VAT, if applicable, would need to be settled by the client.

What is the likely production volume?​

The manufacturer has full production capacity and has the required export certificate.  European based distributor has already delivered both machines and kits to several European countries and these are working. The challenge is reverse: the client (NHS, government, lab) needs to tell us and the manufacturer how many kits you would like over the next month or 3 and we can then come back with a firm offer within 24 hours.

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

For scale the process probably should be automated. The manufacturer of the test kit proposes a machine that automates sample processing and can prepare 96 plate in 30 minutes followed by real time PCR 90 minutes. total time for 96 plate is 2 hours. Detection limit is 200 copies per ml.

Who are you already partnering with on this?

We have proposed this to PHE  via email to covidtestingtriage@dhsc.gov.uk and via testing website where we have uploaded all documentation (which at the moment remains confidential). We have been doing this since 17th March but there is no interest which we find quite sad. Yes the manufacturer is based in China and yes it might be a challenge getting this transported but all the kits and equipment are CE marked and deployed in other countries. It is also very competitively priced. I hope that this message board might help to get this product at least tried?

I will also post for POC (we have real time PCR in POC) and I am checking virus inactivation (it seems that sample can be heat inactivated and the kit will still work but I am waiting for confirmation from the distributor and manufacturer). Please feel free to contact us

margot.gralinska@healhtlinked.co.uk

ronnie monaghan@healthlinked.co.uk

Commenting is closed

Panagiotis Pantelidis Apr 13, 2020

I noticed that the test uses "No extraction - unique formula of lysis buffer allows rapid lysis and release of target DNA/RNA at room temperature"
This means that the samples is not heat inactivated and therefore the test should be performed in CL3.

Dr Margot Apr 13, 2020

Apologies I should have made it clear the sample is inactivated before testing in water/liquid 56c for 30 minutes. I am trying to confirm whether the sample can actually be inactivated at testing site and then transported for processing within 24 hours which would also address the challenge of viral transport. The manufacturer provides swab and test tube with Lysis Buffer.

Dr Margot Apr 13, 2020

This test kit is used with POC device and as far as its use in other countries it is done in simple laboratory as all equipment is compact and fits on lab bench. I do no think they use laminar flow cabinets although each lab and hospital selects its own procedures. I will be posting on POC later this afternoon.

Kathryn Perera Apr 13, 2020

Dr. Gralinska, thank you for the summary and attached file. Kathryn

Kyle Beacham Apr 14, 2020

Status label added: D

Dr Margot Apr 14, 2020

Good morning
Could you please explain what the different labels mean?
Thank you

Kyle Beacham Apr 14, 2020

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

Dr Margot Apr 14, 2020

cheers

Kyle Beacham Apr 14, 2020

The idea has been progressed to the next milestone.

Dr Margot Apr 14, 2020

Good evening
I have got a notification that I need to answer additional questions in edit function but I cannot see any questions except boxes for experts. If you can clarify that would be great
tx Margot

Users tagged:

Kyle Beacham Apr 14, 2020

Hi Dr Margot, the questions are for the Expert Review team to answer. No further questions are required from yourself at this time, however the review team may be in touch (either via this commentary section or directly) to further discuss your idea. Sorry for the confusion. Thank you

Bev Matthews Apr 23, 2020

Status label added: D1

Dr Margot Apr 23, 2020

Good afternoon
I am happy to provide any additional information. As far as I know 10 million tests have been sold in china and 6 million internationally and they are currently being used. Should we decide to progress to meet the testing targets in the UK I will try to get more specific references. MG

Bev Matthews Apr 25, 2020

The idea has been progressed to the next milestone.

Bev Matthews Apr 25, 2020

Status label removed: D

Tom Jordan Apr 28, 2020

Dear Dr. Margot,

Thank you for sharing this with us. Our champions were keen to share your submission more widely. We have added this page to our weekly Testing Methods bulletin, to encourage labs to consider this in detail, test and scale-up.

You can access the weekly bulletins from the COVID-19 resources hub on the RCPath website: https://www.rcpath.org/profession/coronavirus-resource-hub.html

Kind regards,
Tom Jordan
On behalf of the Testing Methods team

Tom Jordan Apr 28, 2020

The idea has been progressed to the next milestone.

Tom Jordan 10 months ago

Status label added: D3: Catalogue of Resources

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