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StableSpot – a stabilised dried blood spot system

A: Not for current challenges

StableSpot is a simple, low cost blood sampling kit which can be deployed rapidly at scale. At the centre of the kit (see attached RADAR study instructions) is a Protein Saver 903 card, which is pre-treated with a proprietary stabilising compound to prevent haemolysis and protein degradation at ambient temperature. A provided finger lancet is used to collect 3-5 droplets of blood onto the card. The card is left to dry for 3 minutes then folded into a foil ziploc bag with dessicant. This is placed into a pre-addressed business reply envelope and posted back to the laboratory or health service collating the samples. The sample can be easily retrieved and eluted at the lab for immunoglobulin or DNA analysis.  

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

Yes the whole sample collection service by post, sample elution and protein assay (C-reactive protein) have been validated by the Gibson lab at Ulster University as part of the RADAR study of 100 arthritis patients over a 6 week follow up (NCT02809547). A copy of the study manuscript currently in peer review can be found at: https://www.researchsquare.com/article/rs-20680/v1

Previous work by the Gibson lab indicates immunoglobulin can be readily recovered by this method. They have also recovered cytokine TNFalpha assayed by ELISA, drug metabolites quantified by LC/MS and DNA to perform both whole genome sequencing and targeted SNP analysis.

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

Could be deployed at scale within 3 weeks. dependent on availability of Protein Saver cards, or similar DBS filter paper, foil bags and finger lancets. Both readily available at relative low cost. Remaining pieces of kit are paper based instructions, barcode labels, preaddressed envelope which can be produced at scale in District Health Trusts.

An app to accompany the kit could be designed from scratch in 6 weeks from below partners.   

What is the likely production volume?​

100,000-200,000 per month for complete kit (as described in attached instructions).

Could be increased nationally, depending on regional distribution centres.

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

Automation preferable to scale addition of stabiliser to cards. Possible with extra lab staff practicing social distancing.

If app is used, software development lead time and publication on apple and android stores.

Who are you already partnering with on this?

Northern Ireland Centre for Stratified Medicine, Ulster University, UK. ( https://www.ulster.ac.uk/research/topic/biomedical-sciences/research/northern-ireland-centre-for-stratified-medicine )

3Advance, Washington DC, USA  app development company ( https://3advance.com/ )

How does this fit into a tracked sample pathway?

Barcode/QR sample card labelling can be used to provide the user with a unique sample ID. Users would be required to add their initials and date/time information of sample prior to posting (particularly if multiple household occupants to be sampled simultaneously).

An app could be used to automate linkage of sample ID and user via a QR code. Registration via app could also be used to collect other demographics, geolocation and history of proximity to other mobile phone users (very useful for contact tracing). All info could be blinded by sample ID and data  encrypted before being relayed to a secure cloud server. Registration would be incentivized, as results of the test could be relayed quicker via the app.

 

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David Gibson

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Simon Parker 8 months ago

There have been numerous examples in the literature to show this methodology can and will work with antibody testing in UK going back to the days when antibody screening for HIV was first done on DBS residues from Guthrie cards. The issue is can the assay overcome the loss of sensitivity associated with using much less sample than would be used in serum or plasma testing without a corresponding loss of specificity. Its a tricky conundrum.

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David Gibson 8 months ago

Some ELISAs can work with relatively small plasma volumes such as Immunodiagnostik ELISAs (https://tinyurl.com/ycogslj5) which need 10ul plasma per well. These DBS cards can hold five blood droplets with at least 12ul each spot.

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Bev Matthews 8 months ago

The idea has been progressed to the next milestone.

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Bev Matthews 8 months ago

Status label added: C

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David Gibson 8 months ago

Appears this has been in review for a couple of weeks and assessed as a 'C', please do get in touch for further info, had no direct contact

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Bev Matthews 7 months ago

Hello David, your solution has been assessed and they would be interested to hear new information when it become available. Our follow up team will be in contact early next week. Bev

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Upamali (Mali) Perera 7 months ago

Hello Bev, I am able to assist David with further information. Cytiva (formerly GE healthcare) manufacture the 903 cards, if I can get a contact email I will pass on more information. my email upamali.perera@cytiva.com

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Upamali (Mali) Perera 7 months ago

Hello David, thank you for your post. I am from Cytiva (formerly GE healthcare) I can most definitely help you with further information we have. My email address is upamali.perera@cytiva.com. if you drop me an email I can send the information through. Thank you Mali

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Bev Matthews 7 months ago

Status label added: B: One to watch

Status label removed: C: Further assessment

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Bev Matthews 7 months ago

The idea has been progressed to the next milestone.

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Tom Jordan 6 months ago

Hello David, everyone,

Thanks for sharing this and for the discussion in the comments. In light of the MHRA's 8 June letter on results using capillary blood sample collection kits, we are not able to pursue this at the moment. As with all ideas on the platform we are keeping a record of what people have posted in case it is helpful to make future contact.

I hope you understand and we're very grateful again for your input on the platform.

Tom
Testing Methods team

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Tom Jordan 6 months ago

The idea has been progressed to the next milestone.

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Tom Jordan 6 months ago

Status label added: A: Not for current challenges

Status label removed: B: One to watch

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