UK approves Dragonfly Respiratory diagnostic

ProtonDx’s Dragonfly Respiratory Panel has been validated and approved for sale under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) Regulations 2021 (CTDA).

Dragonfly achieves 100 per cent sensitivity and 100 per cent specificity in the CTDA validation.

Using a single patient respiratory swab, Dragonfly can detect and identify Influenza A Virus (IAV), Influenza B Virus (IBV), Respiratory Syncytial Virus (RSV), Human Rhinovirus (HRV) and Severe Acute Respiratory Syndrome Coronvirus 2 (SARS-CoV-2) in one test.

Bob Enck, Chairman and President of ProtonDx, said: “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.”

He added: “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.

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, explained: “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.”