The blue circular CovidNudge cartridge in the NudgeBox analyzer. Photo credit: Thomas Angus / Imperial College London
In a new study, a 90-minute COVID-19 test was shown to have a sensitivity of over 94 percent and a specificity of 100 percent.
The work, published in The Lancet Microbe, was led by scientists from Imperial College London. The study used high-speed, laboratory-free tests that can be performed in cartridges smaller than a cellphone on 386 NHS staff and patients.
The lab-in-cartridge rapid test device, which can be performed at a patient's bedside, has been shown to have a sensitivity of over 94% and a specificity of 100%, meaning it has a high level of accuracy and only very few false negatives and no false negatives generated positive.
The test is currently being used successfully in eight London hospitals and is expected to be rolled out nationally. The data will continue to be collected by the tester for continuous evaluation. The UK government recently ordered 5.8 million test kits.
To perform the test, a patient's pediatric nasal swab is inserted into the device, who then looks for traces of genetic material related to the SARS-CoV-2 virus that causes COVID-19.
A result is available within 90 minutes compared to conventional COVID-19 tests that provide a result in 24 hours. The test is currently being developed for the simultaneous assessment of Flu-A, Flu-B and RSV as well as COVID19.
Professor Graham Cooke, lead author of the study in the Infectious Diseases Division at Imperial, said, "These results suggest that the test, which can be performed at a patient's bedside without handling specimens, is as accurate as standard laboratory tests. Many tests involve a tradeoff between speed and accuracy, but this test does both. Developing an effective bedside test in less than three months has been an incredible collaboration between teams of engineers, clinicians and virologists. "
Manufactured by DnaNudge, an Imperial start-up headquartered in White City, the device was found in 280 NHS workers suspected of COVID-19, 15 patients in A&E with suspected COVID-19, and 91 inpatients (some of them) used showed no COVID-19 symptoms).
The samples from each person in the study were analyzed on both the rapid test device known as the COVIDNudge test and on the standard equipment of the hospital laboratory, and the results were then compared.
The research team, which included scientists and clinicians from Imperial, the NHS Trust of Imperial College Healthcare, DnaNudge, the NHS Foundation Trust of Chelsea & Westminster Hospital, and the NHS Trust of Oxford University Hospitals, assessed the sensitivity and specificity. Sensitivity is a measure of how well a test will give a positive result for people with illness and an indication of how likely it is that a test will give false negative results. Specificity, on the other hand, is a measure of the ability of a test to give a negative result for people who do not have the disease and is an indication of the likelihood of false positive results.
The percentage of those found positive for COVID-19 was 18 percent (the study was conducted at the peak of COVID-19). The results showed that 67 samples tested positive in the COVIDNudge test, compared to 71 positive results against a range of standard NHS laboratory machines, a value of 94 percent sensitivity. The study was supported by the National Institute for Health Research at Imperial Biomedical Research Center Regius Professor Chris Toumazou, CEO and Co-Founder of DnaNudge and founder of the Institute of Biomedical Engineering at Imperial, said, "The DnaNudge test was developed as a laboratory-free, on-site consumer service, which can be offered at We therefore strongly believe that it offers very significant potential for mass population testing during the COVID-19 pandemic, and the platform is well suited for testing in primary care and in the community with potential for use in facilities outside of healthcare such as nursing homes, schools, transportation hubs, offices and, to bring the arts back, in theaters and venues. Further studies of actual effectiveness in non-clinical settings would be needed before full deployment. "
The research team added that the device recently received a CE mark allowing its additional use in non-clinical locations (it was previously approved by the UK's Medicines and Healthcare Regulatory Authority).
The team explains that each device is Wi-Fi enabled so the test result can be securely sent to a hospital's recording system.
Testing for this study took place between April 10 and May 12 at three NHS sites: St. Mary & # 39; s Hospital, NHS Trust of Imperial College Healthcare, London; NHS Foundation Trust of Chelsea & Westminster Hospital, London, and John Radcliffe Hospital, NHS Foundation Trust of Oxford University Hospitals, Oxford.
Dr. Bob Klaber, director of strategy, research and innovation at Imperial College Healthcare NHS Trust, said. "As an organization, our focus is on using research and innovation to continuously improve care. It has been great to work so closely with scientists, clinicians and innovators from DnaNudge, Imperial College London and the Trust along with many of our patients and staff To assess the feasibility and validity of this exciting test. Getting accurate results back to doctors and their patients quickly makes a huge difference in how we safely manage clinical pathways and we look forward to expanding them further. "
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Quick 90-minute COVID-19 test has been shown to be very accurate (2020, September 17)
accessed on September 17, 2020
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