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Dry swab and test medium provided with one tube COVID kit and validated

D2

The swab and transport media are part of our complete one tube kit (posted under RNA extraction challenge). The IFU states for swabbing: "after rotation/sample collection" quickly put into specimen collection tube containing lysis buffer (proprietary) or sample storage reagent containing RNA inhibitor. Insert swab, then break the sterile swab near rod near the top, tighten tube cap and seal with sealing film". 

Specimens to be tested can be immediately processed, stored at 4C if processed within 24 hours. Specimens that cannot be tested for 24 hours should be transported in sealed frozen pitcher with ice.

Given the 24 hour validated is feasible to take a sample anywhere and transport to the lab. The kit works on several platforms such as Roche and ABI so it could address the challenge if there is spare capacity.

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

We also have swabs from another manufacturer, dry flocked, comes with 2 types of viral reservation media.

Second medium is virus inactivation BUT our primary manufacturer would need to validate this for his complete kit. Subject to interest from the U they would be prepared to do the validation in their facility in the next 3-4 weeks.

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

Available now with COVID test kits (see entry under RNA challenge)

What is the likely production volume?

At the moment will be made available with CE marked kits. 

Separate query could be raised for the supply of dry swabs and containers if there is interest.

 

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

None

Who are you already partnering with on this?

We represent the manufacturer for the UK.

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Sonia Gandhi Apr 19, 2020

Status label added: C

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Dr Margot Apr 20, 2020

Sonia
Just to add to this: we have access to swabs from another manufacturer that has 2 types of media "normal" and viral inactivation. For the second one (swab plus tube with inactivation media) it would need to be validated that it still works with our PCR kit but if there is interest at some point we could combine providing validated swab plus tube and in parallel test additional media (first manufacturer wold do that for us). Please let me know

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Bev Matthews Apr 21, 2020

The idea has been progressed to the next milestone.

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Bev Matthews May 13, 2020

Status label added: B: One to watch

Status label removed: C: Further assessment

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Tom Jordan Jun 9, 2020

Thank you for sharing this product with us. We have referred this to colleagues leading on the supply of swabs and, if this is appropriate for them, they will make direct contact with you.

Kind regards,
Tom Jordan
On behalf of the review team

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Tom Jordan Jun 9, 2020

The idea has been progressed to the next milestone.

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Tom Jordan Jun 10, 2020

Status label added: D2

Status label removed: B: One to watch

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