- Rapid molecular point-of-care diagnostic system reliably detects SARS-CoV-2, Flu A, Flu B, RSV and Human Rhinovirus
- Clinical test results for CTDA validation achieved 100% sensitivity and 100% specificity
- UK approval follows CE-IVD mark
LONDON, Feb. 6, 2023 /PRNewswire/ -- ProtonDx'sDragonfly™ Respiratory Panel – a rapid, accurate, and portable point-of-care molecular test that identifies multiple common respiratory pathogens - has been validated and approved for sale under the UK Health Security Agency's Medical Devices (Coronavirus Test Device Approvals) Regulations 2021 (CTDA).
Developed by ProtonDx using its propriety rapid sample preparation and molecular diagnostic system, Dragonfly™ achieved 100% sensitivity and 100% specificity in the CTDA validation.
Using a single patient respiratory swab, Dragonfly can specifically detect and identify Influenza A Virus (IAV), Influenza B Virus (IBV), Respiratory Syncytial Virus (RSV) and Human Rhinovirus (HRV) and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in just one test.
Bob Enck, Chairman and President of ProtonDx, stated: "At ProtonDx, our focus is on supporting virus detection to prevent the spread of infectious disease. Respiratory infections often have similar symptoms, but treatments should be targeted. So being able to rapidly identify the pathogen can influence treatment decisions, including in determining whether antibiotics are required.
"That is why cost-effective, rapid, accurate multi-pathogen identification tests, like the Dragonfly 5-in-1 Respiratory Test Panel, have the potential to revolutionise rapid infectious disease diagnosis and tracking worldwide and aid in the global fight to address the issue of antimicrobial resistance (AMR)."
Dragonfly uses proprietary ultra–fast nucleic acid extraction and isothermal detection, combined with single-use test panels, to deliver portable, cost-effective multi-pathogen detection. It provides PCR-equivalent sensitivity and specificity in less than 30 minutes from sample to result - without the need for a lab.
With the addition of Dragonfly to the CTDA register of approved COVID-19 diagnostic products, UK healthcare providers can have confidence in the performance and quality of the single-use disposable detection kit. The system is also available as an in vitro diagnostic tool in Europe, following ProtonDx receiving a CE–IVD mark last year. The CE-IVD mark confirmed that the Dragonfly system complies with the European In–Vitro Diagnostic Directive (IVDD 98/79/EC).
Assistant Professor Jesus Rodriguez-Manzano, Co-Founder and Chief Scientific Officer at ProtonDx, and Deputy Director of the Centre for Antimicrobial Optimisation (CAMO) at Imperial College added: "Having a rapid and accurate diagnostic that can test for multiple pathogens at the point-of-care enables an understanding of which viruses might be causing respiratory infection symptoms. This can then help inform guidance on whether self-isolation is required to help prevent the spread of the infection(s) to others – which is particularly critical in hospital and care situations."
Within the UK population, COVID-19 remains prevalent and an important area of research and monitoring.
Notes to Editors
About (Coronavirus Test Device Approvals) CTDA validation
On 28 July 2021, legislation came into force which introduced validation for antigen and molecular coronavirus (COVID-19) detection tests. The statutory instrument made under the Medicines and Medical Devices Act 2021 requires manufacturers or distributors of antigen and molecular COVID-19 tests to apply to the Department of Health and Social Care (DHSC) to undergo mandatory desktop review to assess tests performance before being put into service, supplied and permitted for sale on the UK market.
The review is intended to prevent products that are below the minimum standards from progressing to the market as set out in the Medical Devices (Coronavirus Test Device Approvals) Regulations 2021.
Dragonfly is a portable, rapid molecular diagnostic system able to accurately identify multiple viral pathogens at the point-of-need. It is uniquely suited for infectious disease testing in healthcare settings where portability and quick access to accurate results can support timely treatment decision–making, helping to minimise unnecessary antibiotic use.
It is suitable for trained users in hospitals, care homes, the workplace, at sporting and entertainment events, and for travel where testing prior to close contact can avoid disruption and minimise risk to health and wellbeing. The system was successfully employed at the 2022 Commonwealth Games and by Team GB at the 2022 Winter Olympic Games in Beijing, China.
Each Dragonfly Test Panel has been developed using proprietary chemistry/reagents to facilitate detection of specific pathogens, when used in conjunction with the Dragonfly platform. The 5-in-1 Respiratory Test Panel delivers cost efficient accurate determination of the presence of up to five respiratory pathogens from a single sample - Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A Virus (IAV), Influenza B Virus (IBV), Respiratory Syncytial Virus (RSV) and Human Rhinovirus (HRV).
By receiving a CE–IVD Mark, the Dragonfly system complies with the European In–Vitro Diagnostic Directive (IVDD 98/79/EC) which means it is commercially available as an in vitro diagnostic tool in Europe.
ProtonDx Ltd was founded in 2020 by Professor Pantelis Georgiou (CEO), Assistant Professor Jesus Rodriguez-Manzano (CSO), and Dr Nicolas Moser (CTO), of Imperial College London to deliver ultra- rapid, extremely precise, molecular testing for everyone at the point-of-need to facilitate detection of infectious pathogens worldwide.
Its core technology builds on a decade of innovative research in diagnostics and collaboration between engineering, medicine and molecular biology carried out at Imperial College London by a dedicated multidisciplinary team. ProtonDx team's ambition is to ensure tests can be conducted quickly, accurately and cost-effectively, wherever and whenever they are needed.
Further information: www.protondx.com
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