VIDIIA Hunter: a low-cost, smartphone connected, artificial intelligence-assisted COVID-19 rapid diagnostic platform approved for medical use in the UK
Introduction: Accurate and rapid diagnostics paired with effective tracking and tracing systems are key to halting the spread of infectious diseases, limiting the emergence of new variants and to monitor vaccine efficacy. The current gold standard test (RT-qPCR) for COVID-19 is highly accurate and s...
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| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2023-09-01
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| Series: | Frontiers in Molecular Biosciences |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmolb.2023.1144001/full |
| _version_ | 1797643730461655040 |
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| author | Aurore C. Poirier Ruben D. Riaño Moreno Leona Takaindisa Jessie Carpenter Jai W. Mehat Abi Haddon Mohammed A. Rohaim Craig Williams Peter Burkhart Chris Conlon Matthew Wilson Matthew McClumpha Anna Stedman Guido Cordoni Manoharanehru Branavan Mukunthan Tharmakulasingam Nouman S. Chaudhry Nicolas Locker Anil Fernando Wamadeva Balachandran Mark Bullen Nadine Collins David Rimer Daniel L. Horton Muhammad Munir Roberto M. La Ragione Roberto M. La Ragione |
| author_facet | Aurore C. Poirier Ruben D. Riaño Moreno Leona Takaindisa Jessie Carpenter Jai W. Mehat Abi Haddon Mohammed A. Rohaim Craig Williams Peter Burkhart Chris Conlon Matthew Wilson Matthew McClumpha Anna Stedman Guido Cordoni Manoharanehru Branavan Mukunthan Tharmakulasingam Nouman S. Chaudhry Nicolas Locker Anil Fernando Wamadeva Balachandran Mark Bullen Nadine Collins David Rimer Daniel L. Horton Muhammad Munir Roberto M. La Ragione Roberto M. La Ragione |
| author_sort | Aurore C. Poirier |
| collection | DOAJ |
| description | Introduction: Accurate and rapid diagnostics paired with effective tracking and tracing systems are key to halting the spread of infectious diseases, limiting the emergence of new variants and to monitor vaccine efficacy. The current gold standard test (RT-qPCR) for COVID-19 is highly accurate and sensitive, but is time-consuming, and requires expensive specialised, lab-based equipment.Methods: Herein, we report on the development of a SARS-CoV-2 (COVID-19) rapid and inexpensive diagnostic platform that relies on a reverse-transcription loop-mediated isothermal amplification (RT-LAMP) assay and a portable smart diagnostic device. Automated image acquisition and an Artificial Intelligence (AI) deep learning model embedded in the Virus Hunter 6 (VH6) device allow to remove any subjectivity in the interpretation of results. The VH6 device is also linked to a smartphone companion application that registers patients for swab collection and manages the entire process, thus ensuring tests are traced and data securely stored.Results: Our designed AI-implemented diagnostic platform recognises the nucleocapsid protein gene of SARS-CoV-2 with high analytical sensitivity and specificity. A total of 752 NHS patient samples, 367 confirmed positives for coronavirus disease (COVID-19) and 385 negatives, were used for the development and validation of the test and the AI-assisted platform. The smart diagnostic platform was then used to test 150 positive clinical samples covering a dynamic range of clinically meaningful viral loads and 250 negative samples. When compared to RT-qPCR, our AI-assisted diagnostics platform was shown to be reliable, highly specific (100%) and sensitive (98–100% depending on viral load) with a limit of detection of 1.4 copies of RNA per µL in 30 min. Using this data, our CE-IVD and MHRA approved test and associated diagnostic platform has been approved for medical use in the United Kingdom under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals, CTDA) Regulations 2022. Laboratory and in-silico data presented here also indicates that the VIDIIA diagnostic platform is able to detect the main variants of concern in the United Kingdom (September 2023).Discussion: This system could provide an efficient, time and cost-effective platform to diagnose SARS-CoV-2 and other infectious diseases in resource-limited settings. |
| first_indexed | 2024-03-11T14:20:15Z |
| format | Article |
| id | doaj.art-4604e3de3f93494b8195e3590bbe53aa |
| institution | Directory Open Access Journal |
| issn | 2296-889X |
| language | English |
| last_indexed | 2024-03-11T14:20:15Z |
| publishDate | 2023-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Molecular Biosciences |
| spelling | doaj.art-4604e3de3f93494b8195e3590bbe53aa2023-10-31T17:05:37ZengFrontiers Media S.A.Frontiers in Molecular Biosciences2296-889X2023-09-011010.3389/fmolb.2023.11440011144001VIDIIA Hunter: a low-cost, smartphone connected, artificial intelligence-assisted COVID-19 rapid diagnostic platform approved for medical use in the UKAurore C. Poirier0Ruben D. Riaño Moreno1Leona Takaindisa2Jessie Carpenter3Jai W. Mehat4Abi Haddon5Mohammed A. Rohaim6Craig Williams7Peter Burkhart8Chris Conlon9Matthew Wilson10Matthew McClumpha11Anna Stedman12Guido Cordoni13Manoharanehru Branavan14Mukunthan Tharmakulasingam15Nouman S. Chaudhry16Nicolas Locker17Anil Fernando18Wamadeva Balachandran19Mark Bullen20Nadine Collins21David Rimer22Daniel L. Horton23Muhammad Munir24Roberto M. La Ragione25Roberto M. La Ragione26Department of Comparative Biomedical Sciences, School of Veterinary Medicine, University of Surrey, Guildford, United KingdomVIDIIA Ltd., Surrey Technology Centre, Guildford, United KingdomDepartment of Comparative Biomedical Sciences, School of Veterinary Medicine, University of Surrey, Guildford, United KingdomVIDIIA Ltd., Surrey Technology Centre, Guildford, United KingdomDepartment of Microbial Sciences, School of Biosciences, University of Surrey, Guildford, United KingdomBerkshire and Surrey Pathology Services, Molecular Diagnostics, Royal Surrey County Hospital, Guildford, United KingdomDivision of Biomedical and Life Sciences, Faculty of Health and Medicine, The Lancaster University, Lancaster, United KingdomThe Royal Lancaster Infirmary, University Hospitals of Morecambe Bay NHS Foundation Trust, Kendal, United KingdomThe Royal Lancaster Infirmary, University Hospitals of Morecambe Bay NHS Foundation Trust, Kendal, United KingdomGB Electronics (UK) Ltd, Worthing, United KingdomGB Electronics (UK) Ltd, Worthing, United KingdomGB Electronics (UK) Ltd, Worthing, United KingdomDepartment of Comparative Biomedical Sciences, School of Veterinary Medicine, University of Surrey, Guildford, United KingdomDepartment of Comparative Biomedical Sciences, School of Veterinary Medicine, University of Surrey, Guildford, United KingdomCollege of Engineering, Design and Physical Sciences, Brunel University London, Uxbridge, United KingdomCentre for Vision, Speech and Signal Processing, University of Surrey, Guildford, United KingdomCentre for Vision, Speech and Signal Processing, University of Surrey, Guildford, United KingdomDepartment of Microbial Sciences, School of Biosciences, University of Surrey, Guildford, United KingdomCentre for Vision, Speech and Signal Processing, University of Surrey, Guildford, United KingdomCollege of Engineering, Design and Physical Sciences, Brunel University London, Uxbridge, United KingdomGB Electronics (UK) Ltd, Worthing, United KingdomBerkshire and Surrey Pathology Services, Molecular Diagnostics, Royal Surrey County Hospital, Guildford, United KingdomVIDIIA Ltd., Surrey Technology Centre, Guildford, United KingdomDepartment of Comparative Biomedical Sciences, School of Veterinary Medicine, University of Surrey, Guildford, United KingdomDivision of Biomedical and Life Sciences, Faculty of Health and Medicine, The Lancaster University, Lancaster, United KingdomDepartment of Comparative Biomedical Sciences, School of Veterinary Medicine, University of Surrey, Guildford, United KingdomDepartment of Microbial Sciences, School of Biosciences, University of Surrey, Guildford, United KingdomIntroduction: Accurate and rapid diagnostics paired with effective tracking and tracing systems are key to halting the spread of infectious diseases, limiting the emergence of new variants and to monitor vaccine efficacy. The current gold standard test (RT-qPCR) for COVID-19 is highly accurate and sensitive, but is time-consuming, and requires expensive specialised, lab-based equipment.Methods: Herein, we report on the development of a SARS-CoV-2 (COVID-19) rapid and inexpensive diagnostic platform that relies on a reverse-transcription loop-mediated isothermal amplification (RT-LAMP) assay and a portable smart diagnostic device. Automated image acquisition and an Artificial Intelligence (AI) deep learning model embedded in the Virus Hunter 6 (VH6) device allow to remove any subjectivity in the interpretation of results. The VH6 device is also linked to a smartphone companion application that registers patients for swab collection and manages the entire process, thus ensuring tests are traced and data securely stored.Results: Our designed AI-implemented diagnostic platform recognises the nucleocapsid protein gene of SARS-CoV-2 with high analytical sensitivity and specificity. A total of 752 NHS patient samples, 367 confirmed positives for coronavirus disease (COVID-19) and 385 negatives, were used for the development and validation of the test and the AI-assisted platform. The smart diagnostic platform was then used to test 150 positive clinical samples covering a dynamic range of clinically meaningful viral loads and 250 negative samples. When compared to RT-qPCR, our AI-assisted diagnostics platform was shown to be reliable, highly specific (100%) and sensitive (98–100% depending on viral load) with a limit of detection of 1.4 copies of RNA per µL in 30 min. Using this data, our CE-IVD and MHRA approved test and associated diagnostic platform has been approved for medical use in the United Kingdom under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals, CTDA) Regulations 2022. Laboratory and in-silico data presented here also indicates that the VIDIIA diagnostic platform is able to detect the main variants of concern in the United Kingdom (September 2023).Discussion: This system could provide an efficient, time and cost-effective platform to diagnose SARS-CoV-2 and other infectious diseases in resource-limited settings.https://www.frontiersin.org/articles/10.3389/fmolb.2023.1144001/fullrapid diagnosticsLAMP (loop mediated isothermal amplification)COVID-19artificial intelligenceinfectious diseases |
| spellingShingle | Aurore C. Poirier Ruben D. Riaño Moreno Leona Takaindisa Jessie Carpenter Jai W. Mehat Abi Haddon Mohammed A. Rohaim Craig Williams Peter Burkhart Chris Conlon Matthew Wilson Matthew McClumpha Anna Stedman Guido Cordoni Manoharanehru Branavan Mukunthan Tharmakulasingam Nouman S. Chaudhry Nicolas Locker Anil Fernando Wamadeva Balachandran Mark Bullen Nadine Collins David Rimer Daniel L. Horton Muhammad Munir Roberto M. La Ragione Roberto M. La Ragione VIDIIA Hunter: a low-cost, smartphone connected, artificial intelligence-assisted COVID-19 rapid diagnostic platform approved for medical use in the UK Frontiers in Molecular Biosciences rapid diagnostics LAMP (loop mediated isothermal amplification) COVID-19 artificial intelligence infectious diseases |
| title | VIDIIA Hunter: a low-cost, smartphone connected, artificial intelligence-assisted COVID-19 rapid diagnostic platform approved for medical use in the UK |
| title_full | VIDIIA Hunter: a low-cost, smartphone connected, artificial intelligence-assisted COVID-19 rapid diagnostic platform approved for medical use in the UK |
| title_fullStr | VIDIIA Hunter: a low-cost, smartphone connected, artificial intelligence-assisted COVID-19 rapid diagnostic platform approved for medical use in the UK |
| title_full_unstemmed | VIDIIA Hunter: a low-cost, smartphone connected, artificial intelligence-assisted COVID-19 rapid diagnostic platform approved for medical use in the UK |
| title_short | VIDIIA Hunter: a low-cost, smartphone connected, artificial intelligence-assisted COVID-19 rapid diagnostic platform approved for medical use in the UK |
| title_sort | vidiia hunter a low cost smartphone connected artificial intelligence assisted covid 19 rapid diagnostic platform approved for medical use in the uk |
| topic | rapid diagnostics LAMP (loop mediated isothermal amplification) COVID-19 artificial intelligence infectious diseases |
| url | https://www.frontiersin.org/articles/10.3389/fmolb.2023.1144001/full |
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