Periodic Reporting for period 2 - RAPID-COVID (Robust Automation and Point of Care IDentification of COVID)
Berichtszeitraum: 2021-08-01 bis 2022-04-30
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.
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.
Successfully developed two syndromic respiratory panels undergone comprehensive analytical validation; compiled technical file; completed clinical evaluation at HCS and APHP; panels CE marked and have the appropriate regulatory approval for sale in the EU, with planned transition into IVDR compliance by 2025.
Successful transfer of assay on automation system to decrease hands-on time required for assay setup; additional hardware and software revisions implemented; systems used at both hospitals as part of clinical testing; technical documentation submitted to regulatory body for CE-IVD approval.
Successfully developed software prototype, conforming to ISO13485 and IEC62304, to automatically analyse test results to complete workflow; enables automatic analysis of qPCR data; the software has undergone clinical testing.
Clinically tested a PoC diagnostic with clinical samples.
Dissemination
1. Publication led by HCS "SARS-CoV-2 POINT-OF-CARE TESTING to the “World Journal of Microbiology and Biotechnology” accepted for publication
2. Manuscript“An economic evaluation of two PCR-based respiratory panel assays for patients admitted to hospital with community-acquired pneumonia (CAP) in the UK, France and Spain” submitted for publication
3. Presentation to PPI group at Portsmouth Hospital, UK, to two different groups and involved an informative Q&A session with Patient Research Ambassadors
4. Digital and print media including TV and radio interviews, press releases, social media posts, local and regional newspapers
5. Conference attendances jointly exhibited by PrimaDiag and GeneFirst
Exploitation
1. Increase in number of distributors, laboratories and hospitals showing interest in respiratory testing workflow; converted 3 labs; provisional annual turnover greater than 500K €/yr
2. Industrial and capital partnership between PrimaDiag and Biosynex in March 22' to further the automation development program at PrimaDiag, resulting in an investment of 2.4M € in PrimaDiag.
Successful transfer of assay on automation system to decrease hands-on time required for assay setup; additional hardware and software revisions implemented; systems used at both hospitals as part of clinical testing; technical documentation submitted to regulatory body for CE-IVD approval.
Successfully developed software prototype, conforming to ISO13485 and IEC62304, to automatically analyse test results to complete workflow; enables automatic analysis of qPCR data; the software has undergone clinical testing.
Clinically tested a PoC diagnostic with clinical samples.
Dissemination
1. Publication led by HCS "SARS-CoV-2 POINT-OF-CARE TESTING to the “World Journal of Microbiology and Biotechnology” accepted for publication
2. Manuscript“An economic evaluation of two PCR-based respiratory panel assays for patients admitted to hospital with community-acquired pneumonia (CAP) in the UK, France and Spain” submitted for publication
3. Presentation to PPI group at Portsmouth Hospital, UK, to two different groups and involved an informative Q&A session with Patient Research Ambassadors
4. Digital and print media including TV and radio interviews, press releases, social media posts, local and regional newspapers
5. Conference attendances jointly exhibited by PrimaDiag and GeneFirst
Exploitation
1. Increase in number of distributors, laboratories and hospitals showing interest in respiratory testing workflow; converted 3 labs; provisional annual turnover greater than 500K €/yr
2. Industrial and capital partnership between PrimaDiag and Biosynex in March 22' to further the automation development program at PrimaDiag, resulting in an investment of 2.4M € in PrimaDiag.
The diagnostic assays developed are state-of-the art. At the onset of the project in the early stages of the pandemic, no rapid, high-sensitivity, PoC options were available for the diagnosis of SARs-CoV-2. The consortium is proud to have developed and validated the a PoC option that not only identifies SARS-CoV-2 but also other key respiratory pathogens. The rapid development and validation of this state-of-the-art COVID diagnostic contributes to broaden the toolbox of diagnostics available to healthcare professionals and public health institutions allowing them to respond in different ways to the rapidly evolving COVID situation. This should allow continued effective suppression of SARS-CoV-2, protection against future outbreaks of COVID-19 via rapid deployment of diagnostic services and continued protection of at-risk facilities such as care-homes. The multiplex nature of the kit allows management of the ongoing COVID-19 pandemic whilst also responding to the imminent threat of increased influenza and RSV disease due to waning immunity in the community.
A completed clinical validation of the syndromic respiratory panels includes demonstration of the functionality of the automated system and data-analysis software also contributes to state-of-the-art. The high throughput nature of these panels support health services and society in multiple ways. It can be used to maintain low levels of COVID-19 disease via effective diagnosis of low incidence SARS-CoV-2. It can also aid in rapid identification of potential COVID-19 outbreaks, thus protect against potential future variants. Finally, it can protect against potential increases in the spread of other respiratory pathogens, incidence of which has been suppressed by COVID-19 control measures.
Together, these two diagnostics formats should help protect health services from the risk of upcoming respiratory pathogen peaks (whether SARs-CoV-2 or other) and support the return to normal social and economic functions.
A completed clinical validation of the syndromic respiratory panels includes demonstration of the functionality of the automated system and data-analysis software also contributes to state-of-the-art. The high throughput nature of these panels support health services and society in multiple ways. It can be used to maintain low levels of COVID-19 disease via effective diagnosis of low incidence SARS-CoV-2. It can also aid in rapid identification of potential COVID-19 outbreaks, thus protect against potential future variants. Finally, it can protect against potential increases in the spread of other respiratory pathogens, incidence of which has been suppressed by COVID-19 control measures.
Together, these two diagnostics formats should help protect health services from the risk of upcoming respiratory pathogen peaks (whether SARs-CoV-2 or other) and support the return to normal social and economic functions.