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Rapid remote COVID-19 testing: a convenient and accessible testing alternative

Additional information

SH:24 is a multi-award winning health tech company, delivering online sexual and reproductive health services across the UK, 24:7. We offer a range of services including home STI testing, treatment, remote diagnosis, contraception, interactive sexual health risk assessments, all supported by unrivalled specialist clinical advice and support. Having delivered over 300,000 tests in the past year, we are seen as the leading STI test provider and are fully integrated into the NHS.

Using our well-established home testing model we propose a rapid remote COVID-19 testing service that would allow key workers and the general population (targeted through an intuitive risk assessment) to access testing by either ordering a COVID-19 test kit online to be delivered to the home or by picking-up a test kit from a designated location.

We would use our existing technology and approach to online / remote testing to quickly build the new testing service, capitalising on our design-led approach. Our online and offline user journeys would be adapted to gather key personal information (e.g. name, age, contact details, address) and risk status (e.g. symptoms / type of symptoms) so that users could order or pick-up a COVID-19 test kit. Kits ordered online would be dispatched on the same day and sent out by 1st class Royal Mail. As we currently do for our testing services, we would verify users’ mobile phone numbers during the ordering process to ensure contact with them can be maintained throughout the user journey (up to issuing results and providing subsequent medical advice +/- referral).

On receiving the kits service users would complete the sample at home using a straight forward test kit with clear and visual instructions (including the option of nasal and oral swabs). Samples would be inserted into their protective cover (UN3373, PI650 compliant), placed in a prepaid envelope and returned by Royal Mail or courier to one of our partner laboratories (UKAS 15189 accredited) for PCR testing, one of which uses Hologic’s fully automated Panther Fusion System.

Results would be transferred from the laboratory to SH:24 within 72 hours via our established secure digital transfer protocol and we would automatically send the results to the user by SMS, advising them on any next steps. We would share results with PHE / other bodies as required by the Government. Once the testing model was established SH:24 could potentially adapt its contact tracing service to undertake digital contact tracing with those who test positive.

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

Yes. We would be using leading UKAS 15189 accredited laboratories, undertaking established PCR testing methodologies, one of which is using Hologic's fully automated Panther Fusion Systems. Both laboratories are approved to undertake COVID-19 testing offering both very high sensitivity and specificity.

Transit of samples would be UN3373 and PI650 compliant.

SH:24 was established in 2013 and is commissioned for its testing services by the NHS, local government and Public Health England.

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

The rapid remote COVID-19 testing service could be spun-up within 1 week as it would be an extension of our current testing services. We would harness our existing infrastructure and partners to achieve this and run an agile intensive lead-in, prioritising this work to support the government meet its targets.

Both of our laboratories are currently PCR testing COVID-19 for the Government and have confirmed that they have the capacity and reagents to test the samples that would be acquired through our rapid remote COVID-19 testing model. Alternatively, we could develop a digital transfer link with the three mega laboratories currently being set-up allowing them to manage all the pathology. We currently hold significant stock of dry swabs that could be used for this proposal and have access to a reliable supply chain to source more (or different swabs) if required.

Our experienced designers and developers would be able to design and deploy a short online journey and test kit instructions / supporting collateral within 1 week by adapting our current platform, and then optimising once live through our ‘build-test-learn’ development cycle. 

Our operations and logistics team are able to source the test kit consumables and build the test kits ready for dispatch to users. We have a fully operational logistics centre in the Midlands that has continued to send out same day dispatch testing kits throughout the COVID-19 outbreak due to business continuity measures undertaken whilst COVID-19 was impacting other countries. Our logistics centre sends out test kits for a wide range of infections and across multiple product lines and is well accustomed to preparing large volumes of kits ready for new testing services.

What is the likely production volume?

Whilst we currently work with 2 major laboratories in the UK, our platform can plug into multiple laboratories – so the production volume would contingent on how many laboratories we launched with, and if these were the three mega laboratories. 

Our laboratories could immediately process 1,100 tests per day for us – with the opportunity to increase volumes if this became a preferred route of testing for the government.

Our model is built to scale, so as other partner laboratories came on board, we would be able to deliver significant increases in testing volumes. Our proposal offers the opportunity to undertake mass testing of the population in a rapid and convenient manner, negating the need for others to take the samples from the users.

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

Our unique design and clinically-led approach to developing digital testing, diagnosis and treatment services has helped us to mitigate the risks traditionally associated with digital development. Our refined operating model (using lean principles) and robust supply chain (including our pathology providers) provides us with an excellent foundation for scaling testing up and sustaining it on a long-term basis if required.

We’ve highlighted 3 primary risks (and responses) that would need to be considered:

Risk 1

Developing a service that users don’t want to use or having a poor test kit return rate

Response

We would mitigate this by using our tested design-led approach to create a simple user journey (both digital and non-digital) with few potential ‘cliff-edges’. Our learning since 2014 has helped us to understand how test kit design and effective communication (especially via SMS) can support users effectively to order and return samples. Our user journey replicates the best of e-commerce models creating an experience that is rapid, convenient and trusted. Our test kit return rate is typically 85 – 96% (much higher than any other online testing services).

Risk 2

Risk of people not testing appropriately 

Response

Our clinical team harnesses leading clinical expertise and has extensive experience of working with pathology providers. SH:24 also has public health experts working within our multidisciplinary team, including our managing director was also a public health consultant. Combining this experience / knowledge with our designers would help ensure that test kit instructions and support would equip users to effectively complete the tests. Our error rate for swab based testing is currently less than 1%.

Risk 3

Concerns of Royal Mail sorting offices re: cross infection from handling the prepaid return envelopes

Response

We have a strong relationship with the Hazardous Goods Department at Royal Mail and would work with them to agree the most appropriate postage categorisation for the return of samples. We could also create a bespoke courier sample return service. One our laboratory partners already has an established courier service within London to transport samples, which could be used for London testing.

Who are you already partnering with on this?

SH:24 works in partnership with 2 leading pathology providers in the UK (and worldwide). We have worked with these laboratories on a long-term basis, delivering a diverse portfolio of tests across the UK and in Europe. The laboratories have the highest level of accreditation with excellent testing capacity and are currently testing for COVID-19 using high performing platforms. SH:24 also has well-established relationships with local authorities, NHS Trusts and government executive bodies such as Public Health England (which commissions SH:24 to deliver the National HIV Testing programme). The nature of our relationships, which support health promotion, triage and referral, means that we can integrate our services seamlessly and effectively into any onward service if required.

edited on Apr 16, 2020 by Glyn Parry
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gpom Apr 16, 2020

Great organisation, excellent track record of delivering diagnostic tests with speed and high quality - they would be the perfect team to undertake this and would love them to turn their hand to Covid-19 testing.

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C Ebanks Apr 16, 2020

Are you already supplying these test kits with instructions? is there an example to view and what is the cost or predicted cost for such a service?

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Glyn Parry Apr 16, 2020

Hello,

We would supply these kits with carefully designed instructions and other support materials (such as videos) to support the users. We can share examples of some of our current instructions if helpful.

Testing in this way decreases the overheads associated with testing at physical locations - so we anticipate this is a more efficient way of testing for the government and could free-up resources to support other work related to COVID-19.

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Sue Hill Apr 19, 2020

has there been any validation on viral detection using dry swabs or are you looking at a different swab ?

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Bev Matthews Apr 21, 2020

The idea has been progressed to the next milestone.

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Bev Matthews Apr 21, 2020

Status label added: Requested more information

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Bev Matthews Apr 21, 2020

Hello Glyn, thank you for your submission. we are awaiting your response to Sue Hill's question below regarding validation. Looking forward to hearing from you. Bev

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Glyn Parry Apr 22, 2020

Hello Bev / Sue,

Apologies for not responding sooner - I did try yesterday and thought I couldn't respond to the question post the application moving to the next stage.

The dry BD swab is validated for use and is already being used for testing on the UK population at the moment for the testing. TDL / The Doctors Laboratory (the lab we use for testing) are already undertaking COVID-19 testing as part of the current testing programme and use both the wet and dry swabs. TDL is listed on the Capacity Data Site for NHSE – so their activity is included in the country’s data and all positives are reported by TDL to PHE every morning on a daily basis

There is published performance for no extraction material - which I will share this morning when the director I work with at TDL gets into work.

Some further information that might also be helpful
- RNA = 6 days stability
- we have the current instructions for the test kit we could share if helpful (SH:24 can review these if necessary - to optimise return rate / align with name / any required official branding of the service). Lab turnaround has been confirmed as 2-3 days (so slightly faster than in our application)
- COVID-19 swabs are confirmed acceptable as CATB postal pathology; we have other approved delivery mechanisms to the lab we can provide more detail on too
- TDL do not currently run the antibody test (IgG/IgM) at the moment but when they do, it will be an automated ELISA laboratory test, not a Rapid linear flow (cartridge) test. So once / if efficacy of the IgG/IGM test is confirmed - this could be another testing product in addition to the PCR added to the service/platform at a later date.

Hope this is helpful and please do not hesitate to get in contact for further information

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Bev Matthews Apr 22, 2020

Thank you Glyn, the milestone was just catching up with the conversation, rather than progressing it :). I'll amend the status label now that you have responded and will come back to you once Sue has reviewed your response.

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Glyn Parry Apr 22, 2020

Hi Bev / Sue,

As promised further information- with regard to assay performance I have attached details which show sensitivity 98%, specificity 100%, accuracy 98.8% for the main assay (direct PCR method). As for all PCR results these would be reported as Negative, Positive or Failed.

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Glyn Parry Apr 28, 2020

Is there any update on the status of this response. We provided a response almost a week ago but the status still says 'requires more information'. Many thanks Glyn

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Glyn Parry May 13, 2020

Could you confirm the outcome of this submission please? There was a guarantee that all submissions would be assessed.

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