The consortium has developed a range of diagnostic tests capable of supporting COVID-19 control at different locations and stages of the COVID-19 pandemic. To effectively control the spread of SARS-CoV-2 and allow an increasing return to normal life, it is important that healthcare providers have a diverse range of diagnostic tools at their disposal. The consortium has focused on optimisation of a rapid, point-of-care (PoC) diagnostic tool to allow high-sensitivity SARS-CoV-2 testing that can be strategically deployed at a range of sites. Such PoC devices, giving results under 1 hour, will be critical in protecting high risk populations from the disease. Examples include admission of patients into intensive care units or allowing entry of visitors into care homes. As vaccination and increased immunity continues to suppress levels of SARS-COV-2, such systems will be a key tool in controlling localised outbreaks due to their relative portability and high sensitivity.
The consortium has developed diagnostic panels which screen for multiple respiratory pathogens (including SARS-CoV-2) causing similar respiratory symptoms. These automated, high-throughput (HTP) testing can be used detect both the presence of a SARS-CoV-2 infection but also the presence of co-infections with other respiratory pathogens. This gives increased information to clinicians to support treatment decisions and improve patient outcomes. Furthermore, as the incidence of COVID-19 gradually decreases with time, COVID-19-only diagnostics will likely become less cost-effective relative to diagnostic panels which screen patients for a range of common respiratory pathogens. The importance of such diagnostics cannot be understated as a decrease in the circulation of a number of respiratory pathogens (such as Influenza A/B) over the last 2 years due to the presence COVID-19 restrictions is predicted to have led to lower levels of community immunity and thus to a risk of higher incidences of these respiratory pathogens in the coming years. These respiratory panels will be critical in supporting treatment decisions whilst maintaining surveillance on SARS-CoV-2, supporting control of SARS-CoV-2 spread and allowing rapid identification of potential localised outbreaks of new variants.
We have achieved the following in respect to the overall objectives:
1. Two CE marked respiratory panel assays covering a broad spectrum of viruses and bacteria, passing all internal verification and validation criteria
2. An enhanced robotic platform that transitioned from a prototype to a final system where the accreditation file for CE-IVD has been submitted
3. A prototype software capable of interpreting melt curve assays, with an accurate decision algorithm and a user-friendly interface, capable of LIS integration
4. Clinical testing of the respiratory panels with samples collected from both Spain and France
All of the above contributed towards a fully HTP testing workflow, demonstrating the added value of such workflow to address the changing needs of testing labs post-pandemic.
We have also evaluated a PoC system that's capable of detecting SARS-CoV-2 at a comparable performance level to a market-leading supplier. We propose that that under certain healthcare settings, a first line PoC for fast turnaround and second line triage of HTP testing can be beneficial especially in the context of addressing changing testing requirements.
