The recent COVID-19 pandemic was a humanitarian and economic disaster, directly contributing to at least three million deaths and costing as much as US$15.8 trillion1. The pandemic also had many indirect effects on our health, with routine operations and medical diagnoses being delayed due to strict lockdown measures and the overwhelming impact of COVID-19 on healthcare systems2. Finally, the fear, isolation and anxiety caused by the pandemic are more difficult to quantify but will be felt by many people for years to come3.
Molecular diagnostics (MDx) played an important role in life ‘returning to normal’. However, things could have been very different if high-performance MDx devices had been widely available from the beginning of the COVID-19 pandemic.
In this blog, we reflect on the benefits and limitations of MDx during the pandemic. We then imagine a future pandemic scenario where polymerase chain reaction (PCR) testing at the point of care, or point of need, could prevent large numbers of deaths , allow life to continue to a greater extent, and make QuantuMDx’s vision of democratised healthcare a reality.
Molecular diagnostics and the UK’s response to COVID-19
Healthcare infrastructures, economic situations and governmental attitudes to COVID-19 varied enormously between countries. Hence, this blog will focus on the United Kingdom (UK). We use the term ‘point-of-need’ to describe the use of rapid diagnostics not only in healthcare settings, but also out in the community.
Lockdown: the first months of COVID-19
On 23rd March 2020, the UK government announced the start of a national lockdown. Official COVID-19 case numbers and fatalities were increasing rapidly, and it was believed (correctly) that this was only the tip of the iceberg due to limited diagnostic testing.
Over the next few months, as COVID-19 cases and excess deaths continued to rise, individuals and businesses tried to adapt to an unprecedented situation. Working from home, furlough schemes, wearing face coverings- and social distancing measures became the norm.
A key problem was not knowing exactly who had COVID-19 at any one time. Many COVID-19 symptoms are similar to those of other respiratory viruses, such as influenza (Flu). Some people only experienced mild COVID-19 symptoms (or were entirely asymptomatic). Furthermore, COVID-19 sufferers could be contagious days before the symptoms of the virus began to present themselves.
In the early days of the pandemic, the only way to determine who had COVID-19 was by using a PCR test.
Access to PCR-based COVID-19 testing
According to the Foundation for Innovative New Diagnostics (FIND), “Accurate… PCR tests for SARS-CoV-2 were available for limited use in laboratories within 8 days of the WHO declaration of COVID-19 as a Public Health Emergency”, and the production of PCR tests was scaled-up for use in larger health centres within 2-3 months4.
Initially, COVID-19 testing was focussed on those in greatest need, such as healthcare workers and immunocompromised individuals. However, processing swab specimens and returning a COVID-19 diagnosis often took many days. This was due to
- the expert handling required for nucleic acid extractions,
- the relatively low number of Biosafety Containment Level 3 (CL3) laboratories,
- the limited capacity of PCR machines in centralised CL3 laboratories,
- the limited availability of PCR test kits.
This hampered well-intentioned initiatives such as NHS Test & Trace.
Even many months later, PCR testing capacity was limited, and COVID-19 test results were not returned for some time. This made it impossible for the UK government to offer the daily testing of symptomatic (and asymptomatic) individuals that may have allowed any kind of normality to return.
The availability of antigen-based COVID-19 testing
As well as PCR-based testing, the development of lateral flow tests (LFTs) for COVID-19 was an important step towards the lifting of lockdown measures. LFTs were easy to use and returned diagnostic test results within minutes.
LFTs for COVID-19 were tested and trialled in 2020, but were not universally available until April 20215, more than a year after the first national lockdown was imposed in the UK.
In addition, the limited sensitivity of LFTs could often cause ‘False Negative’ results for individuals in the early stages of a COVID-19 infection. ‘False Positive’ results were also commonplace (often in people who had previously had COVID-19 but were no longer symptomatic or contagious). The numbers of ‘False Negative’ and ‘False Positive’ results may have been reduced if PCR-based testing had been as accessible as LFTs.
A future pandemic scenario
‘Disease X’ is a term used in the field to refer to ‘the next pandemic’. For our purposes, we will assume that Disease X is a highly contagious, potentially fatal respiratory virus in the same vein as COVID-19.
A rapid PCR test before work?
Even before the emergence of COVID-19, it was acknowledged that the financing and adaptability of MDx devices – and their integration into existing healthcare systems – required significant improvement if the world was to be adequately prepared for future pandemics6.
With a portable, user-friendly instrument that offers rapid PCR-based diagnostic testing, a member of the general public could provide a swab sample and receive an accurate Disease X diagnosis in less than half an hour.
If PCR-based diagnostic testing was widely distributed and easily accessible, there would be no need to transport a large number of swab samples to a centralised laboratory. All tests could be done at the community level, meaning that a diagnostic result could be within walking distance for most people.
It is possible to envisage a scenario where a person goes to their nearest clinic in the morning, returns a ‘Negative’ test result for Disease X, and continues their daily routine safe in the knowledge that they pose no danger to others. Conversely, a ‘Positive’ test result could allow individuals to isolate themselves quickly enough to avoid spreading the virus to others.
Regular PCR-based MDx testing (of symptomatic and asymptomatic people) has the potential to significantly limit the spread of Disease X and improve the effectiveness of NHS Test & Trace and similar initiatives.
Finally, introducing MDx devices into settings with an urgent need for rapid, accurate Disease X diagnoses – such as care homes – could significantly reduce the number of fatalities and relieve some of the pressure on healthcare systems.
A much shorter lockdown?
Realistically, any future pandemic scenario would probably involve a ‘lockdown’ of some kind. After the genetic sequence of Disease X is discovered, any PCR tests would need to be designed, tested, transferred to a MDx device, validated, and finally scaled-up for mass manufacture before community testing could begin.
A ‘100 Days Mission’ – aiming to mount an effective response to a future pandemic within 100 days – is an ambitious but achievable target, and would build on the lessons learned from COVID-197.
A portable, PCR-based MDx device could offer significant help in achieving this target:
- Worldwide pathogen surveillance could identify Disease X in the early stages.
- The spread of Disease X could be limited by rapid, accurate diagnostic test results at the point of need.
A matter of time
It seems inevitable that the world will experience another pandemic similar to COVID-19 in the future. A future pandemic could result in significant loss of life, economic consequences and global uncertainty.
However, hindsight is 20/20, and the importance of quality MDx devices is now widely appreciated. A focus on pathogen research and on the funding, manufacturing and distribution of MDx devices would limit the impact of a future pandemic and ensure that the COVID-19 experience is not repeated.
QuantuMDx: high-quality MDx at the point of need
Since the company was founded in 2008, QuantuMDx has focussed on developing high quality, affordable & rapid molecular diagnostics.
QMDx technology incorporates PCR-based testing into our portable instrument, the Q-POC™ and is currently expanding its product portfolio to include many more MDx tests. If you are interested in more information or have a molecular assay which would benefit from automation at the point of need , we invite you to get in touch with the QuantuMDx team.
