Study In The Lancet Microbe Shows CovidNudge Test Performs With Comparable Accuracy To Lab Tests – Delivering Results Within 90 Minutes
London, United Kingdom, September 17th 2020 – An academic paper published today demonstrates that DnaNudge’s pioneering rapid CovidNudge test, already successfully deployed in NHS hospitals and now being rolled out nationally, delivers highly accurate results without the need for a laboratory or any manual sample pre-processing. The details of the study – “CovidNudge: diagnostic accuracy of a novel lab-free point-of-care diagnostic for SARS-CoV-2” – have been published today in the peer-reviewed journal The Lancet Microbe. The research involved 386 NHS staff and patients and found that CovidNudge test’s average sensitivity – the ability to correctly identify those with COVID-19 – was 94.4% compared against standard NHS lab-based tests, while its specificity – correctly identifying those without the disease – was 100%, meaning no false positives were recorded. The full paper can be accessed at The Lancet Microbe website here: http://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(20)30121-X/fulltext
Following a major UK government order for 5.8 million CovidNudge test kits in August, the solution is in the process of being deployed UK-wide in NHS urgent patient care and elective surgery settings, plus out-of-hospital locations.
Professor Graham Cooke, lead author of the study from the Department of Infectious Disease at Imperial College London and NIHR Research Professor of Infectious Diseases said: “These results suggest that the CovidNudge test, which can be performed at a patient’s bedside without the need to handle any sample material, has comparable accuracy to standard laboratory testing. Many tests involve a trade-off between speed and accuracy, but this test manages to achieve both. Developing an effective bedside test in under three months has been an incredible collaboration between teams of engineers, clinicians and virologists.”
Access to rapid diagnosis is seen as crucial in the fight against the COVID-19 pandemic, however, Reverse Transcript Polymerase Chain Reaction (RT-PCR) testing usually requires a centralised laboratory and significant infrastructure, leading typically to a 1-2-day wait for results to be returned. This new study describes in detail the development and diagnostic accuracy assessment of DnaNudge’s portable point-of-care test, which has successfully miniaturised the gold-standard lab-based PCR test to be performed by a Wi-Fi-enabled device the size of a shoebox – the NudgeBox – that can accurately detect the genetic material of the SARS-CoV-2 virus from a swab sample in just over an hour.
During the study, swab samples were analysed from 280 NHS staff members with suspected COVID-19, 15 patients in A&E with suspected COVID-19, and 91 hospital in-patients (some of who were not displaying COVID-19 symptoms), comparing the accuracy of the CovidNudge test against NHS standard laboratory RT-PCR testing machines. The percentage of those found to be positive for COVID-19 was 18 per cent (the study was conducted during the peak of COVID-19). The results showed that 67 samples returned positive results using the CovidNudge test, compared with 71 positive results via standard laboratory analysis.
Testing for the study took place between 10th April and 12th May 2020 at three NHS sites: St Mary’s Hospital, Imperial College Healthcare NHS Trust, London; Chelsea & Westminster Hospital NHS Foundation Trust, London and the John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford. The study was led by a research team that included scientists and clinicians from Imperial College London, Imperial College Healthcare NHS Trust, DnaNudge and Oxford University Hospitals NHS Trust, and was supported by the National Institute for Health Research Imperial Biomedical Research Centre.
CovidNudge is a complete Lab-in-Cartridge system that works by placing a swab into a “DnaCartridge” that can extract RNA from both nasal and saliva samples. The cartridge is then inserted into the NudgeBox for analysis and reverse transcribing to DNA. This multiplex technology – which is adapted from DnaNudge’s in-store consumer DNA testing service – can assess the presence of several of the COVID-19 genes, including both the WHO and CDC assays, and also offers the capability to test for FluA, FluB and respiratory syncytial virus (RSV) – a crucial capability ahead of the winter flu season. The CovidNudge test ensures high accuracy and minimisation of ‘false negative’ results via a unique control that tests for human RNA, indicating inadequate swabbing and the potential need for a re-test.
Commenting on the study, the developer of the CovidNudge test, Professor Chris Toumazou FRS, FREng, FMedSci, CEO and co-founder of DnaNudge and founder of the Institute of Biomedical Engineering at Imperial College London said: “The decentralisation of mass testing is now being recognised as the key to addressing this unprecedented public health crisis, and these study results very clearly support the use of CovidNudge as a highly accurate, rapid and near-patient testing solution that can be delivered on-the-spot and at scale, in both clinical and non-clinical settings.”
Working with the UK’s Department of Health and Social Care, and with the authorisation of the Medicines and Healthcare Products Regulatory Agency, DnaNudge began an initial deployment of the CovidNudge RT-PCR test in April 2020 across eight London hospitals– including cancer wards, A&E and maternity departments. The CovidNudge test is authorised for clinical use by the MHRA and is CE-marked for use in non-clinical locations.
For more information about the CovidNudge test, please visit: https://www.dnanudge.com/en/COVID-Nudge
About DnaNudge (http://www.dnanudge.com)
DnaNudge is the developer of the world’s first service to use consumers’ own DNA plus lifestyle factors to nudge people towards healthier choices while shopping. The DnaNudge service analyses and maps users’ genetic profile to key nutrition-related health traits such as obesity, diabetes, hypertension and cholesterol, enabling customers to be guided by their DNA towards healthier eating. The service has been developed by world-renowned biomedical engineer Regius Professor Chris Toumazou FRS and published geneticist Dr Maria Karvela.
This ground-breaking in-store DNA testing service created to address an epidemic – obesity and Type 2 diabetes – has now been successfully adapted for the fight against a pandemic, with the development of the rapid, lab-free CovidNudge RT-PCR test. CovidNudge can accurately detect COVID-19 and other viruses in just over an hour, without the need for a laboratory, and is now in UK NHS roll-out.
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