Over the last 12 months, as we collectively sought a way to avoid Covid transmission, the terms 'lateral flow' and 'rapid antigen test' became an accepted part of the general public's vocabulary, but the technology is not new. For years these easy-to-use devices have been used widely with success: the pregnancy test being the most well-known.
The market – now projected to reach $10.2bn by 2025 – was growing before the influence of the pandemic, and the latest market growth drivers – the increasing prevalence of infectious disease, ageing populations and the demand for point-of-care testing – that were relevant pre-COVID-19 will remain relevant well into the future.
Gardian, an Australian-based digital health company sees the increased awareness of lateral flow's patient-centric capabilities as a major factor as to why the technology will be used more widely going forward.
The response to COVID-19 The spread of SARS-CoV-2 was fast, catching most countries off guard. Governments, policymakers, and stakeholders rallied to try and introduce testing strategies that could deliver fast result turnaround times. Throughout the world, organisations mobilised their operations and developed tests in short timeframes; manufacturing capacities were scaled up to meet demand; testing trials and programmes were initiated to quickly assess the state of the COVID-19 situation and formulate response strategies; and vaccine development programmes were initiated across the globe.
During a trial in the UK, nearly 100,000 lateral flow antigen tests were carried out over a two-week period. Although very important in times of crisis, it was not the volume of tests performed that was of interest for future diagnostic strategies – rather, it was the capability to easily test patients across multiple locations and produce results on site in minutes.
And it was not just COVID-19 rapid tests that hit the headlines in 2020. Sky News reported 'the number of HIV self-testing kits [which included lateral flow] issued in London was 20 per cent higher during the first eight weeks of Covid lockdown than the same period a year before.'
The pandemic has reiterated the value of mass screening and illustrated how getting a broad picture of the status of disease infection as easily and quickly as possible contributes to establishing appropriate and targeted response strategies.
Various diagnostic methods have played their role during the pandemic response. Swab testing at specialised testing centres for a confirmatory result via PCR (Polymerase Chain Reaction) were hailed as the gold standard in Australia until the sheer number of infections overwhelmed the system and the government conceded to the public having access to self-testing.
The global response to the SARS-CoV-2 pandemic suggests however, that laboratory methods may not be the sole solution for infectious disease testing in the future, especially where the need for results is time critical due to a disease's short incubation or latency period: Ebola being one example.
Accurately producing and reporting results on the same day – for all infectious diseases, irrespective of their incubation period – not only delivers a patient-centric response but could potentially also offer resourcing benefits through reducing the number of people needed to process and interpret a result.
It is also important to understand the dynamics and demographics of global populations, to demonstrate fully why the use of rapid tests is beneficial for future testing programmes. It is projected that throughout the world, the number of people aged 60 or above will be approximately 1.4 billion in 2030 and 2.1 billion in 2050. When infectious disease risks are coupled with the fact that ageing populations, with ever greater numbers of chronic ailments and autoimmune conditions, lead to an increase in demand for primary care, patient care systems will be under greater pressures and will need to be responsive and deliver effective diagnostics quickly.
The speed and ease of use of rapid tests could potentially alleviate the pressures on primary care diagnostics by offering a testing solution that does not need several departments to deliver a result. The public have had their eyes opened to the benefits of rapid tests; and this will lead to an increase in demand, with some patients expecting test results to be delivered quickly or immediately. In turn, doctors, by their very nature, will want to supply fast and efficient diagnosis to deliver the best service.
Gardian believes that using rapid tests as a part of 'best practice' approach could benefit diagnostic services in the future. By using lateral flow testing, healthcare systems have an appropriate tool that that may help stop local outbreaks becoming a national or worldwide problem.
Precision medicine, decentralisation, and data Lateral flow technology is not one-dimensional. As COVID-19 research continues it is possible that rapid tests could regularly test positive COVID-19 patients or vaccinated individuals, over months or years, in order to gather evidence for better understanding how long immunity markers stay present in the body.
In another area of diagnostics, the creation of isothermal amplification molecular tests, such as Recombinase Polymerase Amplification (RPA) and loop mediated isothermal amplification (LAMP), has allowed molecular testing to take place in multiple environments with limited resources. A complementary rapid test could negate the use of the traditional method and support a true decentralised, point of care molecular testing solution. So, when combining molecular testing with portable nucleic acid detection rapid tests, the two technologies would become a powerful partner in creating the opportunity to deploy in-field or point-of-care (POCT) molecular testing to multiple locations.
Diagnostics data is an increasingly important commodity for gaining insights into accurately guiding patient treatments or aiding epidemiology studies. Combining smartphone apps, such as Gardian Self Check with rapid tests allows real-time Covid test result data to be captured in situ via the phone's camera and shared via readily available connectivity technology. Collating data in this way provides secure reporting and means treatments, response strategies, improvements or solutions are based on real-time data.
Conclusion While a handful of international organisations were promoting rapid tests and their potential in global diagnostics long before the coronavirus crisis, it is now highly likely, with future pandemic or non-pandemic situations, that the use of rapid tests will be considered more readily.
Rapid and accurate diagnosis technology is available and may be used to deliver the best patient care while protecting the wider public and avoiding bumps in economic productivity.
The role of rapid tests in response to COVID-19 cannot be ignored. It is just a shame that it has taken a global health crisis to raise them on the agendas of government, medical professionals and lay people. As a very small consolation, future generations may well reap the benefit.
The many benefits of lateral flow in decentralised point-of-care testing offer the potential to contribute positively to people's overall well being. Deliver a negative result in minutes to someone who thought they might have a disease: no long anxious wait for the result. Conversely, a positive result means treatment can start there and then: the quick result has a positive impact on both physical and mental health. From a humanistic, commercial and resource management perspective the benefits of offering an easy-to-use fast screening tool, that can also be a companion or complementary diagnostic or combine with data platforms, is the reason why rapid tests may be in greater demand from now on.
