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Rapid RNA purification and stabilisation by cost-effective lateral flow technology

B: One to watch
FloNASep is a simple & rapid biological sample extraction technique for obtaining nucleic acids (including RNA). FloNASep is based on widely-used lateral flow device (LFD) technology and is well-suited to use in the field or at the point-of-care (POC). Please see the product description PDF and take note of the comparable extraction performance with widely-used spin columns. 

 

FloNASep is suitable for extracting, purifying and preserving nucleic acids, antibodies and virus particles (including antigens) from a range of Covid-19 diagnostic samples: including swabbed nasopharyngeal (NP) and oropharyngeal (OP) secretions, sputum, saliva and blood. The extracted target molecules are presented, within a few minutes, in an easily accessible part of the LFD ready for direct inclusion in suitable liquid-based diagnostic tests, e.g. RT-PCR and ELISA. Alternatively the LFD may be dried, without damaging the extracted target molecules contained therein, for long-term storage (years) at room temperature.

 

Unlike existing processes, using FloNASep would mean:

- No shipping of liquid virus transport media containing sample in tubes between collection point and testing laboratory

- No cold-chain shipping required

- No multi-step extraction process of sample upon receipt in laboratory; sample in FloNASep LFD section is ready for immediate RT-PCR analysis, with potential for integration with automated analysers

- No maximum time limit before sample needs to be tested once extracted into LFD

- No refrigeration required for stored samples

 

Additional benefits of FloNASep:

- Shipping an LFD easier than sample in liquid VTM; LFD has much smaller form factor, is lighter and much more robust 

- Single sample LFD provides multiple aliquots for analysis which may be accessed randomly

- Each sample LFD aliquot provides a range of the sample's constituent molecules including cells, proteins, nucleic acids, lipids and other particles

- Sample LFD section is agnostic to downstream processing; for example any nucleic acid amplification technology may be used

 

Applications:

- FloNASep technology could be incorporated into a home sample collection system, if easy-to-provide sample such as saliva delivers satisfactory test performance (sensitivity and specificity)

- Individual FloNASep sample collection kits could be provided rapidly to people showing symptoms of infection; or pre-positioned to improve rapidity of test cycle

- Individual FloNASep sample collection kits could be provided rapidly to people as part of a public-health track and trace virus eradication programme 

- FloNASep technology could also be used by Health Care Professionals (HCP) running public sample collection sites, should testing require NP and/or OP samples

- FloNASep technology could be incorporated into a POC RNA molecular test for Covid-19

 

Outstanding work before FloNASep may be used:

- Validation of FloNAsep extraction on spiked and then clinical samples to demonstrate satisfactory RT-PCR sensitivity

- Development of product packaging to eliminate both potential for sample contamination and infection of transporters and HCPs

 

Scale up:

- FloNASep samples available now

- Scale up of FloNASep production does not pose significant problems
edited on Jul 2, 2020 by Alex Marshall
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Tom Jordan Jul 6, 2020

Status label added: B: One to watch

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Tom Jordan Jul 6, 2020

The idea has been progressed to the next milestone.

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Tom Jordan Jul 6, 2020

Thank for you for this Alex. Our reviewers do think this is an interesting idea. They would like further information on the development of the technology to make it ready to use. In particular one of their questions they had was around how to maximise acceptance of the technology in labs given the multi-step process it requires. Grateful for your thoughts and updates here.

Given the challenge is closed you might need to email me - which you can do at tom.jordan1@nhs.net.

Kind regards,
Tom
Testing Methods team

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Bev Matthews Aug 25, 2020

The idea has been progressed to the next milestone.

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