Reducing the burden of COVID-19; diagnostic tests and the patient pathway

9 December 2020

Tony Cambridge looks at a changing healthcare landscape as the service continues to respond to the ongoing coronavirus pandemic, and considers the role of point-of-care tests and combination testing…

 

New models of care are now the main topic of discussion beyond SARS-CoV-2 vaccines and test availability. It has been clear for some time that healthcare must be delivered in a different way in order to preserve the core services within the healthcare landscape. Patients need to be assessed and managed under new protocols and in new locations in order to safeguard the acute and critical services provided by secondary and tertiary organisations. The impact of a well-governed and accessible diagnostic testing programme is well known, both in hospitals and the community. Now more than any other time, the community settings can provide the support patients need, not only in identifying health conditions at the earliest opportunity, but to manage the progression and resolution of that condition; all without visiting secondary care establishments. In those situations, where secondary and acute care is required, effective diagnostic tools must be adopted in order to optimise care delivery and protect non-infected patients and staff.

The unseen impact of a pandemic

During the SARS-CoV-2 pandemic, diagnostics tests have been central to detecting infections, helping to quarantine and isolate those individuals, but what has been the impact on the population not infected? There have been concerns around mental health, gambling and substance addiction, and significant backlogs for cancer services and surgery, to name a few. Socioeconomic issues have also been evident, not least business and financial implications of the pandemic, restricted freedom of movement and disruption to normal life activities. The full impact of the pandemic is now being realised. Enforced changes to someone’s day-to-day routine can have serious implications for their health and wellbeing. The disruption to education, work life, home life, local and national productivity, has impacted on the accessibility of care. How can accessible diagnostics help to avoid or resolve these issues? A new approach is required, delivered within a new framework of diagnostic testing, standardised across countries and territories.

The power of testing

The true power of a diagnostic test is immeasurable. It is not just the knowledge of whether the patient is affected, positive/negative, normal or abnormal. It is the wider effect that we as healthcare professionals, with the right tools, can have on the impact of each of these elements. Health organisations have the opportunity to transform the way in which the healthcare system approaches the health and wellbeing of global populations. Global and national diagnostics companies, technology start-ups, distributors and adopters all have a valuable part to play in shaping the future of public health. From personalised to precision healthcare, leaders must take a close look at outcomes, assess the effectiveness and viability of current protocols, and support the wave of change that has been lapping at the shores of healthcare in recent years. There have been many initiatives that purported to change the face of global health. Sadly, there remains a gulf between what has been achieved, what can be achieved, and what should be achieved. There is a siloed mentality to healthcare. No matter the territory, each region appears to be looking after its own. With the spectre of local financial governance, unrealistic targets, competition and national pressures, it is no wonder that collaborative working has not brought about the sea change the proposed design will have aspired to deliver.

Enabling long-term change

Global health crises should be enablers for change, but what has been achieved from previous pandemics? Where is the global community output? Information shared relates to mortality and not morality. Where is the global network whose mission statement is to revolutionise healthcare, work together for the common goal, offer transparency and collaborate on the greatest of challenges? The tools are available, the support on offer. It is time to take the initiative. The global healthcare community now needs to grasp the opportunity to forge partnerships with proven diagnostics manufacturers and distributors. Trust is a strong word with many connotations.

This is the time for trust, and not a time for empty promises from leaders outside the healthcare landscape who will not fully understand the solutions they are presenting as the next ‘game changer’. Where a challenge exists there are teams of scientific and clinical staff willing to face it, push the boundaries of science, and deliver a viable solution. The first solution may not be the final solution in all cases, but the commitment to those solutions is unparalleled and should be widely acknowledged. The upscaling of laboratory functions during the SARS-CoV-2 pandemic has shown this is achievable, albeit with personal and professional sacrifices.

Understanding innovation and adoption

This is where the development of new tests astounds and the healthcare industry and research organisation must be congratulated. The speed at which new assays can be added to existing or new platforms is something to both appreciate and be wary of. In the wake of a global health crisis a large number of new tests can flood the health market, causing confusion among the adopters, and inadvertently arrest progress with regard to adoption. Tests released for emergency use only should be used with caution in a long-term clinical setting. Those tests lacking compelling performance data should be avoided. If the data do not give confidence to the user, then how can the best outcome be reliably delivered for the patient? The clear message is to work with trusted and renowned companies. Those who publish their results, freely offer well-defined performance characteristics of their tests, and support implementation and interpretation of the new solution. Knowing the limitations of a new test is as valuable as knowing its best attribute. Working with the supplier to understand the full utility and application of a testing system is key to the success of translating that result into effective care.

Choosing the most effective and impactful solution

One such solution that has stood out in the marketplace is FebriDx (developed and manufactured by Lumos Diagnostics and distributed by Una Health), a rapid point-of-care (POC) triage test which can help prevent the spread of infection and reduce risk in clinical settings. The FebriDx product was shown to be highly accurate in rapid identification of SARS-CoV-2 infections and could be deployed as a front door triage tool in hospitals and urgent care centres, overcoming current issues of delayed diagnosis from reverse transcriptase-polymerase chain reaction (RT-PCR) testing – a methodology with varying turnaround times and sensitivity. FebriDx as a rapid triage tool that detects both influenza and SARS-CoV-2 is likely to be of utility in the coming winter months. FebriDx allows clinicians to identify viral patients in 10 minutes from a capillary whole blood sample; facilitate immediate patient isolation; ensure patients with bacterial infections are not missed; and rule out non-clinically-significant infection. Delays mean that infected and non-infected patients may come into unnecessary contact, resulting in those who are well becoming infected. The situation is compounded by the limited availability of single isolation units, meaning that patients are temporarily held in assessment areas or inpatient wards until results are available. The impact on patient flow and effective care puts additional pressure on already overwhelmed acute services. The use of FebriDx will allow clinicians to make an initial decision for each individual, while waiting for the result of a confirmatory test from the medical laboratory.

Combination testing improves clinical decision-making

The use of FebriDx as a triage tool can help prevent the spread of infection, being the only rapid test able to differentiate viral from bacterial infection due to the detection of both C-reactive protein (CRP), an acute-phase inflammatory protein elevated in acute bacterial and viral infection, and myxovirus resistance protein A (MxA), an intracellular protein with a fast induction time of one to two hours that only becomes elevated in the presence of acute viral infection. By detecting both markers, the sensitivity and negative predictive value of the test is optimised. FebriDx has been demonstrated to be highly accurate at detecting SARS-CoV-2 infections rapidly, including identifying infections that have been missed by RT-PCR testing. Similarly, FebriDx will be important outside the hospital in community diagnostic hubs, care homes and GP practices, and could be deployed in any of the settings previously discussed. It has also been shown that FebriDx is an effective tool in improving antibiotic stewardship and reducing antimicrobial resistance (AMR). It is estimated that 50% of antibiotics prescribed for acute respiratory infections (ARIs) are unnecessary, and this is the leading cause of AMR on a global scale. Rapid identification of patients that need antibiotics and avoiding unnecessary prescribing has a significant impact on the healthcare economy and improves the outcomes for patients requiring treatment. Antimicrobial resistance is a global healthcare issue with the potential to render many therapies and medications ineffective, increasing morbidity and mortality across all territories.

The power to disrupt care pathways

The term ‘game changer’ is used all too frequently, mainly as a political battering ram. The public are not easily convinced, as may have been the case historically. The power needs to be returned to the term, and multi-centre decentralised diagnostics have the potential to do this. The right test delivered at the right time, provided on a reliable platform, used by trained staff who can interpret and act on the results, has the power to disrupt the delivery of care as it is presently known. Might FebriDx be a true game changer?The test performance is compelling,
the impact realised and presented in multiple studies. How can the change be facilitated?National bodies in global territories need to be receptive to change in the first instance. No change is no longer an option. Leading clinicians need to influence the direction of travel. Diagnostics companies need to understand the problem to be solved. Together, an array of solutions to common and complex health conditions and diseases are possible. Each of these solutions has the
ability to positively impact on morbidity, mortality and long-term outcomes for patients from all backgrounds. Geographical, demographical or sociological implications must not figure when it comes to population health.

A standardised approach

A standardised approach to the adoption of new tests is required. This starts with the verification work need to confirm the performance characteristics stated by the provider. It concludes with the implementation of the solution at ground level where clinicians can have complete confidence in the tools adopted to inform their care decisions. Ultimately, the patient should benefit from the information provided by the test, but it should not be forgotten that inaccurate information offered by a diagnostic test can have widespread implications across society when viewed on a national and global level. This is where policy-makers must be single-minded in the intended outcome of their decisions. Where a positive outcome is expected, what are the relative risks? What might be the impact of adopting a test that could generate an inaccurate result? Is this fully understood? How is this communicated, reinforced and monitored following adoption? Clear information to clinicians on the limitations is key, where clinical knowledge and experience can override where necessary. No test is 100% accurate or precise. It should not be anticipated or expected.

Diagnostics companies work tirelessly to remove the element of doubt, but there is no substitute for clinical presentation and patient history. Test results together with the clinical interpretation will yield the most effective care. The most effective care for any individual would be based on their history, presentation and analytics. Precision care and personalised care can only be achieved when reliable solutions are accessed rapidly by the clinical teams providing care. If there is a narrow spectrum of diagnostics available to the clinician, then patient care slips back into generalised medicine where a battery of tests is ordered on a ‘just in case’ basis. This is not good for the clinician or the patient. It is also a real problem for health economics, patient flow, and limited resources.

Accessibility of diagnostics tests

Where should these diagnostics solutions be offered? There is a growing body of evidence to suggest that performing more tests outside the traditional medical laboratory can yield improved results. The problem remains that the infrastructure cannot currently support this approach, and models of test provision in multiple settings must be devised, for example:

 

  • GPs and Health Centres
  • Primary Care Network Hubs
  • Minor Injury Units
  • Local Care Centres
  • Urgent Care Centres
  • Ambulatory Units
  • Community Clinics (sexual health/family planning)
  • Pharmacies
  • High street wellness centres
  • Community Team home visits Paramedics
  • Ambulance Service (including air)
  • Mobile Units (see list below)
  • Prisons
  • Gyms and Health Centres

 

Areas where large numbers of people would normally gather or visit are also prime locations for diagnostics and require mobile solutions, such as:

 

  • supermarkets
  • sporting events
  • care homes
  • concerts
  • festivals
  • other large gatherings.

 

It is clear that what is needed is a national network of community diagnostics with all results generated available through a complete and accessible patient health record. This requires significant vision and appropriate levels of investment shared between government organisations. Patients presenting with early symptoms of common conditions should be managed away from acute services. Likewise, those presenting with acute symptoms must be able to access diagnostics regardless of the day of the week, or the time of day. Provision of care must not be a lottery; instead it should be standardised to the level that the same care is received when it is required, not based on where or from whom it is received. The banner of community diagnostics covers a multitude of settings and demands an overhaul to the system. From environmental to technical to staffing issues, the redesign of services required is wholesale and could be too much of a challenge for some. However, if patients and clinicians are to benefit from the health system they deserve, the blueprint needs to be designed and implemented now in order to reach the outcome; a more effective, efficient and financially viable service. One that all involved in can be proud.

Future relationships

The system we have become accustomed to is not the system that patients require for the future. Identifying common illnesses early is key to reducing the burden on acute and secondary services. Managing known conditions more effectively will improve measurable outcomes and thus prove the model. Cost avoidance and financial savings will rapidly become apparent, leading to further investment of time and effort in rolling out nationwide and global initiatives. Now is the time for bravery; for leaders in all areas of the healthcare landscape to embrace the solutions clearly available, and engage with global, national and grass-roots diagnostics companies in delivering patient services of the future. Setting firm foundations now is essential for future successes and galvanises the partnerships required to safeguard the longevity of the diagnostics industry and the effectiveness of patient care.