The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulator of medical devices, responsible for ensuring their safety, quality and effectiveness, has accepted the Virolens® rapid testing system for use and sale in Great Britain.
Virolens is a breakthrough technology in virus detection combining holographic microscopy and AI software to analyse the resultant images. A saliva sample is taken using an oral swab. The saliva sample is smeared on a sample slide and images are captured using holographic microscopy techniques. In the case of a positive COVID-19 sample these images contain unique diffraction patterns created by each SARS-CoV-2 virus. The AI software has been trained to look for and count these patterns. The device delivers a yes/no result in around 20 seconds.
Evaluation trials have demonstrated that the Virolens system has a 98.1% sensitivity and 99.7% specificity.
Virolens has been brought from a concept to an approved device in 11 months by a small team working for i-Abra Ltd, based in Bedfordshire, led by Greg Compton in conjunction with TT Electronics, their exclusive global manufacturing partner.
A network of global distributors is in place who are responsible for obtaining regulatory approval in their jurisdictions. Trials are underway in several global markets in support of further regulatory approvals.