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Viral inactivation and concentration through a method of faecal filtration, for the safe testing of patient samples using PCR or EIA methods.

B: One to watch

Apacor’s Parasep faecal concentration devices are marketed worldwide as the leading pre-analytical method for faecal filtration and parasite concentration. By utilising a patented vertical filter design, these devices are able to separate and concentrate parasitic ova/cysts from faecal matter through a simple centrifugal process.

 

Apafix is a patented universal fixative able to effectively neutralise parasites within a sample, whilst retaining complete capacity for PCR and EIA testing to take place. Apafix utilises a targeted approach to fixation through its formulation, allowing the chemical to be safe enough to be used within patient care packs, which are directly used by members of the public in several countries where sold.

 

The Apafix fixative is simple to produce in bulk, safe for the general public to handle, and potentially an excellent medium for faecal sampling and further testing for the COVID-19 virus. Apacor would utilise its existing injection moulding facility to mass produce faecal sample kits. These could be easily distributed to homes across the UK, reducing the need for close proximity between patients and health care professionals, allowing a wide arc of testing to be accomplished through a simple testing medium.

 

The proposed contents of the kit would likely include a vial (two potential sizes – the smaller measuring around 70mm in length and 17mm in width, the larger measuring around 70mm in length and 30mm in width) containing a small volume of Apafix fixative solution, with a sample spoon integrated into the cap of the device. The patient, upon receipt, would take a pea sized sample of stool and place into the fixative solution, before sending to a designated lab for testing.

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

 

Validations have taken place to ensure that Apafix solution is applicable in PCR and EIA testing with no interference after a period of up to 14 days. This minor study was conducted on one species of protozoa, and was only to show the applicability for these forms of testing. Wider sampling has shown that Apafix is able to fix parasitic cysts within a period of 2 minutes, and ova within a period of 10 minutes. The formulation includes compounds considered to be bactericidal, mycocidal, and viricidal, however extensive testing with these organisms has not been conducted due to the target organisms being parasites only.

 

The filtration system has been widely validated for the concentration of ova and cysts in human stool samples, but again, only for parasitic organisms. The Midi Parasep is considered to be the gold standard for UK parasitological filtration and pre-analytical processing of human stool samples.

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

The product is already produced in a large capacity (millions of units per year) and we are able to scale up exponentially due to a recent increase in production capacity. Tests could be release in as little as 1-2 weeks.

What is the likely production volume?

Estimated to be around 10,000 tests per day.

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

Testing will need to be done to determine complete viral inactivation of COVID-19 whilst retaining the necessary structure to be tested post-fixation with Apafix solution. This could be completely negated should the sampling wish to be done on an empty vial basis, however quick transportation would then be necessary for lab fixation.

Who are you already partnering with on this?

Our product is used worldwide in both small and large scale laboratories. Apacor has the capacity to manufacture all required parts and to mass-produce in a short time-frame.

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Bev Matthews May 24, 2020

Status label added: C: Further assessment

Reply 0

Bev Matthews May 24, 2020

Thank you Chloe, our assessors would like to look at your idea a little more closely and we will come back to you if we need more information. Bev

Reply 0

Tom Jordan Jul 9, 2020

Status label added: E: A connection is helpful

Status label removed: C: Further assessment

Reply 0

Tom Jordan Jul 9, 2020

Thanks Chloe - the reviewers have taken a look at this and believe a couple of connections will help this idea. I will post more details shortly today.

Kind regards,
Tom
Testing Methods team

Reply 1

Chloe Winchcombe Jul 9, 2020

Thank you Tom, I look forward to speaking with you.

Kind regards

Chloe Winchcombe
Global sales and marketing manager

Reply 0

Chloe Winchcombe Jul 14, 2020

Dear Tom,

I have not heard anything yet, will you be contacting via email?

I fully understand any delays I just want to check I have not missed anything.

Kind regards

Chloe Winchcombe
Global Sales and Marketing Manager

Reply 0

Tom Jordan Jul 17, 2020

Hello again Chloe, my apologies for the delay.

The reviewers wanted to connect you with colleagues to test out how this inactivates faecal samples. They suggested colleagues at PHE and Oxford are well placed to consider this. If you are happy for me to I will make the connection.

Happy to discuss,

Tom

Reply 0

Chloe Winchcombe Jul 17, 2020

Hi Tom,

Thank you for your reply, yes I am happy for the connection. Do you have my email address?

Thank you

Chloe Winchcombe

Reply 0

Tom Jordan Jul 17, 2020

Hi Chloe, I have your details registered on the platform. I am just checking that colleagues based in PHE and Oxford are also happy to be connected and will join you as soon as they get back to me. Tom

Reply 0

Tom Jordan Jul 23, 2020

Status label added: B: One to watch

Status label removed: E: A connection is helpful

Reply 0

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