Testing Times: Final report on the role of rapid diagnostics in tackling antimicrobial resistance (AMR)

POC CRP has been shown to reduce antibiotic prescribing by 22-36% for respiratory tract infections (RTI)¹, and 22% for COPD,² making it a significant diagnostic intervention in the context of AMR, with RTI and COPD being key indications for antibiotic prescribing in primary care.

Contributors to the interview programme underlined that, despite various pilots and trials, including more than 10 randomised or cluster randomised clinical trials using CRP alone, the use of POC diagnostics has not been significantly adopted by primary care in the UK. They underlined challenges to adoption including funding and commissioning barriers; practical barriers to implementing and embedding diagnostic technology within primary and community care settings; issues surrounding the acceptance of rapid diagnostics amongst clinicians and the need to ensure available evidence on the effectiveness of rapid diagnostics is appropriately shared.

These reflections on the limited uptake of rapid diagnostics echo the UK 5 Year Action Plan on Antimicrobial Resistance: 2019-2024, which underlined that the UK does not make the best use of available diagnostic technology.³ This is despite the fact that POC CRP is widely used in other European countries, such as the Nordics and the Netherlands, with demonstrable impact on antibiotic prescribing levels – these countries having low primary care prescribing rates and strong AMR stewardship programmes.¹

In recent years there have been innovations in diagnostic technology and over the course of the pandemic, health services have increasingly used diagnostic platforms to manage COVID-19 that could support the use of CRP POCT to inform antibiotic prescribing if effectively redeployed across health settings. Going forward, leveraging the potential of these innovations, which are an asset currently held by NHS services, and supporting more widespread use of diagnostic technology should be a central aim of efforts to tackle the threat of AMR.

The scale of the challenge in relation to AMR has been acknowledged by the government in the UK 5 Year Action Plan on Antimicrobial Resistance: 2019-2024. The UK Action Plan sets out a range of objectives in relation to i) reducing the need for and unnecessary exposure to antimicrobials ii) optimising the use of antimicrobials and iii) investing in innovation, supply and access to tackle AMR.³

In May 2022, the government published an addendum to the Action Plan, integrating key learning from COVID-19 in relation to approaches to tackling AMR and revising some of the commitments made in 2019.⁶

A central measure of success in relation to the government’s AMR agenda remains a commitment to be able to report on the percentage of prescriptions supported by a diagnostic test or decision support tool by 2024.³ The addendum to the UK Action Plan makes welcome progress via commitments to support uptake of diagnostic technology and to standardise data collection in relation to their use to inform antibiotic prescribing.⁶

The UK Action Plan was informed by the Review of Antimicrobial Resistance, led by Jim O’Neill, which reported in 2016. The Review made specific recommendations on the use of rapid diagnostics to inform antibiotic prescribing – underlining that high income countries should make it mandatory for all antibiotic prescribing to be informed by data and testing technology by 2020.⁵ It remains the case that rapid diagnostic tools are not widely utilised or effectively integrated into pathways, representing a significant area for reform and innovation in practice that could progress the AMR agenda.

* Figures from The Review on Antimicrobial Resistance. Tackling Drug-Resistant Infections Globally:
Final Report and Recommendations. May 2016. Available: https://amr-review.org

This extends to the fact that many secondary care settings will have purchased diagnostic platforms during the pandemic, some of which could now be redeployed to other settings, such as primary and community care, and used to support AMR stewardship objectives.

A crucial development during the pandemic was the creation of a new informatics infrastructure that was used for surveillance and monitoring of COVID testing, with the system now able to transfer antigen and PCR test results into the patient records of 80-90% of the population. There is an opportunity to leverage this infrastructure to support AMR stewardship, with the potential to expand the diagnostics that are captured within the system and provide improved insights into surveillance of antibiotic prescribing.

At a structural level, the pandemic revealed some of the challenges within the diagnostics sector. One interviewee highlighted that, in comparison to research and development in vaccines, the UK diagnostic sector was more fragmented; received less investment; and was subject to difficult regulatory frameworks – all of which had hindered initial efforts to develop responses and solutions to COVID-19. These points have similarly been made in a recent report published by the Academy of Medical Sciences, which highlighted the need to develop a more ‘fit for purpose regulatory process’ for diagnostics and a need for greater transparency across the pathway from research on diagnostics, through to implementation in community and health care settings.⁸

This provides the necessary assurance for clinicians and managers that the correct governance, training and auditing is in place to support use. They also underlined that embedding technology includes practical challenges, such as decisions regarding where diagnostic platforms are kept within a practice (particularly where practices operate over more than one site).

At a systemic level, another participant reflected that the challenge of practically implementing new technologies into historic health systems was often underestimated, underlining that this will only have been made harder by the additional pressures primary care is facing as a result of COVID-19.

Multiple participants underlined the difficulty in making a business case for diagnostic technology within single practices, stressing that economies of scale and higher throughput of patients were needed to sustain and validify the use of diagnostic platforms. These insights have implications for new service models and pathways going forward.

Despite these practical barriers, it was noted by interview participants that patients do accept the use of rapid diagnostics and can feel reassured by a test that informs clinical prescribing decisions, particularly where the clinical decision is not to prescribe. It was observed that this acceptability will likely increase, in light of the widespread use of rapid diagnostics during COVID-19 and greater patient familiarity with point of care testing. This acceptability is crucial – interview participants agreed that a key element of tackling AMR is to change patient expectations and demand surrounding antibiotic prescribing, making the reassurance and educational opportunity provided by diagnostic interventions a significant benefit for patient care in the future.

In 2014, NICE recommended within Pneumonia in Adults: Diagnosis and Management [CG191] that GPs should consider using POC CRP testing during the community assessment of suspected Pneumonia (LRTI) and outlined suggested levels of CRP that indicated an infection requiring an antibiotic versus those that did not.⁹

During the Testing Times interview programme, participants had mixed views as to the scope of the clinical guideline, with one participant stating that the instruction to consider CRP POCT alongside clinical symptoms was the correct emphasis for clinicians, whilst other contributors underlined the need to make guidance stronger in relation to the use of CRP POCT.

CG191 was withdrawn early in the pandemic for review, in light of the advent of COVID-19 and the need to re-evaluate respiratory infection management pathways during the pandemic. This led to a period where there was no effective replacement NICE guideline in place, although CG191 has since been reinstated, as of July 2022. Whilst it is welcome that the guideline has been reinstated, there is an opportunity to carry out a more comprehensive review of the guideline, with a view to including key patient cohorts, such as those with COPD, within the scope of the guidance and to develop a more robust recommendation on the use of rapid diagnostics to inform clinical decision making.

The Primary Care Respiratory Society (PCRS) recently published a pragmatic guide and algorithm for members on the use of POC CRP for RTI and COPD patients, which provides valuable guidance to clinicians in relation to using rapid diagnostics to inform antibiotic prescribing decisions for patients with respiratory symptoms. Developments such as this should inform NICE’s consideration of the use of CRP within the Pneumonia in Adults: Diagnosis and Management [CG191] guideline, to ensure that it reflects best practice and is fit for purpose.

Additionally, participants in the roundtable meeting highlighted that Managing Common Infections guidelines have been expanded to consider diagnosis and, as a consequence, certain rapid diagnostic tests have been referred via those guidelines to NICE for review. Whilst it is welcome that diagnosis is now considered within the guidelines and providing a pathway for NICE recommendation, some stakeholders underlined the limitations in the current assessment process, which does not incorporate a quantitative economic assessment of the impact of AMR. Whilst NICE will qualitatively consider how a diagnostic test may support AMR stewardship, it is a serious shortcoming that NICE do not use robust economic modelling on AMR within decisions to recommend a test that may support a reduction in antibiotic prescribing.

Overall, there is a need to ensure that NICE is taking a robust and comprehensive approach when assessing the use of rapid diagnostics in clinical pathways and integrating an assessment of the social and economic impact of AMR. The recent addendum to the UK 5-Year Action Plan on AMR retains an incentive to develop and evaluate rapid diagnostics,⁶ but there still exists a gap in relation to incentivising the use of existing diagnostic technology and ensuring that clinical guidelines reflect the value of wider uptake.

Interview participants agreed that funding and commissioning arrangements are also a barrier to uptake of rapid diagnostics in primary care. One participant outlined that Clinical Commissioning Groups (CCGs – now replaced by Integrated Care Systems) rarely included funding for rapid diagnostics to inform antibiotic prescribing within local commissioning arrangements – meaning individual practices would incur additional cost in order to introduce platforms. The participant reflected that ultimately, this was a matter of prioritisation for CCGs – in the absence of stronger expectations and incentives at a national level, prioritisation of AMR does not frequently occur.

One contributor underlined the importance of pilots for the use of rapid diagnostics having clear exit strategies agreed with the relevant CCG, so that necessary funding arrangements can be sustained, with a full understanding of the value of diagnostics as compared to the cost. It was noted that, whilst studies have demonstrated the utility of CRP POCT in reducing index prescribing to patients with respiratory symptoms1 and pilots in primary care have underlined benefits to services, there has been limited sustained uptake – with long-term funding arrangements being a significant hurdle to overcome.

This includes evidence that use of point of care testing to triage acute respiratory infection can reduce unnecessary antibiotics and antibiotic related adverse effects, resulting in significant cost savings.¹¹

One interview participant stressed the significance of the system-wide benefits that would likely follow from embedding rapid diagnostics within health services – supporting greater productivity and efficiency across primary and secondary care, whilst also supporting AMR stewardship. They called for analysis of such benefits to be taken forward by the government as a priority. As highlighted above, current approaches to assessing diagnostics for recommendation in clinical guidelines do not make a quantitative assessment of the economic impact of AMR, limiting the extent to which cost-effectiveness can be meaningfully assessed. A system-wide cost analysis has the potential to support a benchmark against which to consider the utility and value of diagnostic tools in the broader context of the impact of AMR.

These reflections on both cost effectiveness and efficiency in health services are particularly meaningful in the context of pressure on health services as they recover from the pandemic and there is an evident platform to utilise diagnostics to support a more efficient use of primary and secondary care resources.

Contributors highlighted that there has been a consistent focus within AMR policy on innovation and the development of new pipeline antimicrobials and new diagnostic technologies, underlining that current available technology can be overlooked.

One participant underlined that diagnostics are one of the most important elements in the fight against AMR, supporting an overall reduction in antibiotic use, where new antimicrobials sustain the risk of drug resistance ultimately developing.

This view was shared by other participants – and is expressed in the UK 5 Year Action Plan on AMR – that available technology is not optimised across health services and more should be done to support uptake of existing diagnostic solutions.

The refreshed commitments for the AMR Action Plan, published in May 2022, provide some welcome progress towards a stronger focus on facilitating uptake of existing technology, whilst also supporting research and development.

Additionally, stakeholders outlined that there are significant differences between the needs of primary and secondary care when it comes to the diagnostic tests that support clinical decision making. In the context of primary care, the use of prognostic tools – ones that enable clinicians to exclude a need for antibiotic prescribing, can effectively support practice, without a need for more specific diagnostic tools that will determine the infection a patient has.

It was underlined that prognostic tools, such as CRP POCT, can be overlooked when a ‘whole pathway’ approach is taken to assessing the value of diagnostics, as there is an emphasis on specific diagnostics that can siphon patients down a particular route of care and treatment.

In primary care, significant progress in AMR stewardship might be made by identifying patients who have a self-limiting infection that does not need antibiotics – without a need to determine the nature of the infection. There is a need to consider the varying needs of particular settings and not just consider how diagnostics fit into a specific pathway, such as for RTIs or UTIs.