Dragonfly Respiratory Panel reliably identifies five most common causes of respiratory infections, joins list of UK approved diagnostic products

Mon, February 6th 2023

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

Dragonfly Respiratory Panel reliably identifies five most common causes of respiratory infections, joins list of UK approved diagnostic products

London, UK – 06 February 2023 – ProtonDx’s Dragonfly 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.