Members may already be aware through discussions in recent working parties, and the wider NHS Diagnostic Advisory Group about work that is ongoing with NHS England for the piloting of point of care tests in ARI Hubs.
Acute respiratory tract infections in patients place a major burden on health systems each winter. There is an eightyfold increase in respiratory admissions during this period, which has a profound impact on elective activity and hospital targets. Moreover, delays in admission and multiple ward transfers are unsatisfactory for patients and carers, reducing the quality of care and add to length of stay.
Many of these patients who attend emergency departments (ED) with respiratory symptoms are not admitted. Depending upon the underlying condition they may be discharged home but the time for assessment in emergency departments adds an additional burden to already stretched organisations.
To reduce these attendances acute respiratory infection (ARI) hubs have been suggested to assess patients within the primary care setting in an attempt to minimise ED attendances.
Currently, these hubs lack diagnostics, which reduces the potential for managing patients in an appropriate way. Clinical assessment can confirm the most likely reason for the presentation is infection, but hubs are otherwise limited in their ability to offer further management.
There is some confusion across the sector which candidly is due to comms and a number of different projects being undertaken that are linked.
There are some pilots which are underway already, which have been discussed in other meetings and roundtables relating to routes to collaboration between industry and the NHS – notably with Roche, Abbott and bioMerieux which are independent of the NHS England pilot. However, because they are close in scope to the objective, it is understood that the outputs from these will factor into the overall pilot outcome, albeit the original scope may be slightly different, and they will conclude to demonstrate the original objectives of those pilots and feed some data into the ARI pilot.
The objective of this particular work is to pilot the use of point of care tests in acute respiratory infections (ARI) hubs to understand the extent to which they can support clinical decision making in the management of patients and:
- Triage patients to the most appropriate care.
- Enable antimicrobial stewardship.
- Reduce hospital admissions and future attendances at ED.
This is with a view to provide the evidence for a wider roll-out across the NHS in time for Winter 2023/2024. This is anticipated to be absorbed into operations and existing settings and not a newly commissioned (funded) service. Current NHS England funds only cover the pilot phase and expire on 31st March.
The pilot will include tests for C-Reaction Protein (CRP) and Respiratory Syncytial Virus (RSV).
These point of care tests will be obtained from nationally procured overstock that is being made freely available by the UK Health Security Agency (UKHSA) and NHS Supply Chain, respectively. The free provision of these tests enables nationally procured stock to achieve value for money.
To ensure the pilot remains commercially neutral:
- ARI hubs piloting these devices will not be able to specify which they use.
- The devices will not be compared for effectiveness and pilots will focus on clinical decision making and patients’ outcomes blinded to which device was used.
- Results from the pilots will not be specific to either device.
- Any wider roll out of the pilots’ results will require open procurement.
There is also potential to combine these point of care tests with a newly UKHSA evaluated lateral flow device (LFD) multiplex test for Covid and Flu A/B, which has demonstrated effective sensitivity and specificity for flu. UKHSA can make more than 1000 of these tests available to ARI Hubs in combination with Polymerase Chain Reaction (PCR) multiplex tests.
These tests are intended to enable UKHSA to assess whether the LFD multiplex can provide a faster result that is equal to a PCR test. However, the inclusion of these tests in the pilot will depend on flu prevalence, which is currently past its peak. Should these tests be included, they will be used prior to the CRP and RSV point of care tests. A pathway diagram will be developed for the pilot’s scope.
It is not proposed to use the allocated devices to test for Flu A/B, as these have not been UKHSA evaluated.
Use of any point care tests by ARI hubs will require local pathology laboratory validation.
This will require that the hubs participating in the pilots to have access to a mature pathology network with the capacity and processes in place to provide validation and governance.
For the purposes of the pilot, it may also be possible to have pathology networks with point of care experience that are not local to the ARI hubs to provide validation.
As ARI hubs may have limited capacity to collect data it is likely that the evaluation of the pilots will need to qualitative, with ARI hubs completing a short survey for each patient during the consultation to enable results to be gathered throughout the pilot activity.
The survey will require ARI hubs to provide the following:
- Key patient demographics.
- The patient management they would pursue at first assessment of the patient.
- The patient management they will pursue after using point of care tests.
- The immediate outcomes for the patient.
Solutions to assisting the pilot sites with data collection and evaluation would be very helpful.
This pilot should demonstrate that these hubs are a good idea and worth the investment of the Trusts, so to be prepared, members should ensure that they have a compliant route to market in time for a potential roll out (presuming pilot success) and engage with potential customers locally, as the delivery and procurement model (is currently) expected to be through local settings. For members who have indicated that they have solutions to NHS England, these were gratefully received, but the excess stock held will be used. BIVDA will keep members updated on the output of the pilot as it progresses and if funding streams/ or delivery expectations change following the conclusion of this work.
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|Activity||Timescales (week beginning)|
|Identify ARI hubs to participate in the pilots||13 February|
|Obtain overstock of point of care tests|
|Decide on inclusion of LFD / PCR multiplex||20 February|
|Develop evaluation survey – ensuring it can be repeatedly completed|
|Ensure validation of point of care tests||27 February|
|Run pilots||13 March|
|Pilots end||X number of patients in each hub|