Page banner

#TestingMethods2020

NHS Mass PCR Screening Pillar - Pilot for screening all 8000 staff at East Kent: 3CR end-point PCR as a mass PCR screening covid

B: One to watch

Asymptomatic transmission of SARS CoV-2 is a recognised driver of current SARS CoV-2 prevalence and transmission in the community. A recent meta-analysis from Bern reported the symptomatic phase transmission accounts only for about 30% of onward transmission whilst the major contribution for sustained community transmission comes from pre-symptomatic category accounting for 40-50% and true asymptomatic through the entire initial virus exposure accounting for a further estimated 10% of secondary transmissions.

We propose to use end-point PCR validated and employed by 3CR https://testingmethods.crowdicity.com/post/3171230; to test all 8000 members of staff at East Kent Hospitals at weekly intervals for a total of 3 weeks to pilot the economics, logistics, feasibility and outcome measurement of community prevalence characteristics in the presumed higher risk hospital environment amongst the healthcare workers/employees. 

This pilot will cover all the categories of healthcare workers: clinical facing [covid + non-covid clinical area], support services [including all sectors such as pharmacy, estates, pathology and others], corporate [including management, administrative, executive].

This will map to the categorisations in the recent NHSE asymptomatic staff testing pilots:

1 - directly patient facing

2 - non-patient facing but potentially greater exposure e.g. domestic or laboratory staff

3 - non clinical e.g. administration

 

The proposal is to test all 8000 members of East Kent Hospitals over a 3 week period; which amounts to 25,000 tests, cost estimated at £57,000

The end-point PCR system is capable to testing all 25,000 tests in one go; however, we want to demonstrate time trends, persistence and clinical reproducibility and relevance of asymptomatic PCR screening/testing at mass scale to instruct both clinical as well as public health measures to deal with control SARS CoV-2.

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

We have validated the end-point PCR system as a separate and distinct pathway/pillar that is parallel to the Pillar 1 NHS PCR diagnostics. We tested with anonymised samples from current Pillar 1 positive as well as negative samples that were tested in our East Kent Laboratories as part of current 600-700 samples being tested daily. The end-point PCR data signals were analysed in comparison to the realtime PCR wells signals.

The results data plot is attached below in the FIle: "East Kent anonymised - Preliminary End point data"

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

The system can be deployed and the pilot done the moment NHS England and NHS Improvement (NHSE-I) gives approval; which on discussion with NHSE-I can be done as soon as the QCMD Qnostics Analytical Reference Q Panel is assessed by the 3CR end-point PCR system that is soon imminent; which we can update on in the next few days.  

The dependencies are:

NHSE-I being able to provision up logistics for mass PCR swabbing

And if saliva is validated, then the relevant efficiencies and overcoming of barriers related to nose and throat swabs can dependably be linked in to great effect

What is the likely production volume?​

The system can test up to 2500 tests per hour; and can easily be scaled up to testing 50,000 tests per unit. Many such units in one place or distributed locally in different networks can give multiplicity of scale as the needs can be. 

The system used 1/5th the reagent volumes with the up to 100 times higher throughput per unit time per unit

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

The risks are minimal if the IT integrations are worked out to cover individual requestor (be it employer or government agencies) and the community resident GPs and local government database 

Who are you already partnering with on this?

Already partnering with 3CR and we need the NHSE-I approval to facilitate as our Trust (East Kent Hospitals) are part of the Kent and Medway Pathology Network where there are active plans to initiate asymptomatic key workers staff screening across all health and social care organisations which amounts to a total of 25,000 key workers.

The cost of end-point PCR technique as such amounts to £2.50 per test, and that along with time efficiencies, reagent efficiencies will be a necessary alternative to current real-time PCR methods that carry the risk of running out of various reagents and kits as have been made much evident in this forum and others. 

edited on May 25, 2020 by Samuel Moses
Samuel Moses

Attach files

@

Samuel Moses 4 months ago

Posted proposal for pilot of end-point PCR

Reply 2

Quentin Hanley 4 months ago

Fully supportive of this proposal.

Reply 1

Bev Matthews 4 months ago

Status label added: B: One to watch

Reply 0

Bev Matthews 4 months ago

Hello Sam, this looks very interesting and we look forward to hearing the outcome of the pilot. Many thanks Bev

Reply 1

Samuel Moses 4 months ago

Thank you Bev. We are looking to receive the QCMD Qnostics assessment from 3CR soon. And once that is fed up to NHSE and funds for the pilot assured, we will go straight on to this. Thanks a lot for the tremendous help and support you and everyone at NHSE and the partners at National Pathology Alliance are providing over this. Much appreciated.

Reply 0

Samuel Moses 2 months ago

Thanks

Reply 0

Share