Diagnostics
In comparison, point-of-care testing solutions – including both lateral flow and PCR assays – were widely rolled out during the pandemic, and testing was carried out rigorously on all patients showing signs of a respiratory illness. At the same time, preventative strategies – such as physical distancing, increased hand washing, mandatory wearing of face masks and greater ventilation – helped to curb the spread of the disease. Despite a reduction in cases of SARS-CoV-2, the global infectious disease burden has, in fact, increased now that society has emerged from the safety net of widely implemented social distancing measures. The reinstatement of both domestic and international travel – as well as large social events – has resulted in a resurgence of influenza and RSV strains that, until recently, were either dampened by lockdown protocols, or went unnoticed due to diminished public reliance on doctors and hospitals during this time.8 The overlapping symptoms of these common
respiratory illnesses – which often present with congestion, coughing, malaise, myalgia and the potential for fever – can make it challenging to tell them apart. However, there is a growing awareness that distinguishing between respiratory pathogens is necessary to care for patients appropriately, and to effectively contain outbreaks of more contagious diseases. This resurgence of seasonal illnesses has
raised formidable challenges for the healthcare industry, and highlights a key limitation of the COVID-19-specific assays rolled out during the pandemic. These tests were highly sensitive and specific, could detect the virus in a matter of hours, and were constantly updated based on emerging strains of the pathogen, but they could only reveal whether patients were infected with SARS-CoV-2 or not, neglecting the potential for diagnosing additional respiratory diseases. Instead of this, there is an urgent need for enhanced, differential disease testing to discriminate between various respiratory infections (Figure 1).
Adapting to a new diagnostics era One promising solution to meet evolving diagnostics needs in respiratory health is multiplexed assays.9
Multiplexed testing
kits provide a comprehensive approach to pathogen detection, allowing the simultaneous assessment of multiple different viruses and viral strains in a single sample. While these diagnostics solutions hold huge potential to streamline respiratory disease testing, producing an effective multi-target assay presents a number of challenges.
The first hurdle when looking to produce a multiplexed diagnostic test is narrowing down the broad spectrum of current respiratory illnesses to determine which viruses to include in an assay. This requires diagnostics companies to collaborate with clinicians and healthcare services to identify the pathogens of primary concern. In addition, ongoing input from bioinformaticians can be highly valuable to determine any recent shifts in the genetic background of these organisms, and to ensure that the diagnostic assays remain up to date. The second challenge presents itself when designing the diagnostic technology itself; most existing laboratory testing equipment can only run four channels at a time – including controls – so the assay design needs to be compatible with this format, limiting the number of pathogens that can be efficiently tested. Lastly, effective multiplexed assays need to be able to differentiate between various strains of the same pathogen – such as influenza A and B, which need to be reported distinctly to the MHRA – something that not all tests currently on the market can achieve.
Redefining respiratory care with multiplexed assays An effective multiplexed testing kit needs to be designed to detect the most prevalent viruses and strains that currently affect the global population, and to be repeatedly updated based on genomic surveillance data. Fortunately, multiplexed assays – such as the genesig SARS-CoV-2 Winterplex assay (manufactured by Primerdesign, part of the Novacyt Group) – offer a comprehensive and adaptable diagnostics solution to a constantly
changing disease landscape (Figure 2). These specific and sensitive diagnostic tools allow the simultaneous detection of multiple pathogens – including SARS-CoV-2, influenza A/B and RSV – to effectively differentiate between the various seasonal respiratory conditions that may be causing a patient’s symptoms. Multiplexed assays can reinforce existing infectious disease management protocols within a healthcare system, offering a one-stop testing solution to enable more effective management of patients with a range of respiratory conditions. This has benefits for clinicians and patients alike, as the ability to carry out a single test – rather than multiple separate tests for each respiratory illness – conserves valuable resources, while also reducing the time to diagnosis. Multiplexed assays can therefore enable healthcare providers to make faster and better-informed treatment decisions, and quickly implement appropriate isolation measures to prevent disease transmission. In turn, this can help to streamline patient care and reduce strain on healthcare systems, by minimising unnecessary treatments and hospitalisations. Timely diagnosis is especially crucial for the effective medical management of vulnerable populations – including young children, older adults and those with a weakened immune system – who may be more susceptible to severe respiratory complications. Quickly identifying the root cause of their symptoms can enable early intervention, while also reducing the likelihood of misdiagnosis and preventing subsequent transmission of diseases. Multiplexed testing kits also offer patients peace of mind through quicker identification
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