A 90-minute test for COVID-1
The work published in The magazine Lancet Microbe, was led by scholars from Imperial College London. In the study, high-speed tests that do not require a laboratory and can be performed in cartridges smaller than a cell phone were used in 386 NHS staff and patients.
The Lab-in-Cartridge rapid test device, which can be performed in the patient’s bed, has over 94% sensitivity and 100% specificity, which means that it has a high level of accuracy and gives very few false negatives and no false positives. .
The test is currently being used successfully in eight London hospitals and needs to be introduced nationally, and data continues to be collected from the test device for continuous evaluation. The UK government recently ordered 5.8 million of the test kits.
To perform the test, a pediatric-sized nasal swab is inserted into the device by a patient who then looks for traces of genetic material belonging to the SARS-CoV-2 virus that causes COVID-19.
The result is available within 90 minutes compared to conventional COVID-19 testing, which gives a result in 24 hours. The test is now being developed for the simultaneous assessment of influenza-A, influenza-B and RSV, as well as COVID19.
Professor Graham Cook, lead author of the study from Imperial’s Department of Infectious Diseases, said: “These results suggest that the test, which can be performed in a patient’s bed without the need to handle test material, has comparable accuracy. with standard laboratory tests. Many tests involve a trade-off between speed and accuracy, but this test manages to achieve both. Developing an effective bed test in less than three months is an amazing collaboration between teams of engineers, clinicians and virologists. “
The device, manufactured by DnaNudge, a White City-based startup Imperial, was used on 280 NHS employees with suspected COVID-19, 15 A&E patients with suspected COVID-19 and 91 hospital patients (some of whom show no symptoms of COVID-19).
Samples from all individuals in the study were analyzed on both a rapid test device called the COVIDNudge test and standard hospital laboratory equipment – and then the results were compared.
The research team, which included scientists and clinicians from Imperial, Imperial College Healthcare NHS Trust, DnaNudge, Chelsea & Westminster Hospital NHS Foundation Trust and Oxford University Hospitals NHS Trust, assessed sensitivity and specificity. Sensitivity is a measure of how well a test gives a positive result for people who have the disease, and is an indication of how likely the test is to give false negative results. Specificity, on the other hand, is a measure of a test’s ability 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 to be positive for COVID-19 was 18% (the study was conducted at the peak of COVID-19). The results showed 67 samples tested positive in the COVIDNudge test, compared to 71 positive results against a number of standard NHS laboratory machines, representing a value of 94 percent sensitivity. The study was supported by the National Institute for Health Research Imperial Biomedical Research Center .Regius Professor Chris Tumazu, CEO and co-founder of DnaNudge and founder of the Institute of Biomedical Engineering at Imperial, said: which can be delivered on a scale, so we clearly believe it offers very significant potential in terms of mass population testing during the COVID-19 pandemic. The platform is very suitable for testing in primary care and community settings with the potential for use in non-health facilities, such as nursing homes, schools, transport centers, offices and, to help return the arts, to theaters and facilities. However, further studies of the actual efficacy in a non-clinical set will be needed before widespread implementation. “
The research team adds that the device has recently received the CE mark, which allows its additional use in non-clinical locations (previously approved by the UK Medicines and Health Regulatory Agency).
The team explains that each device is activated with Wi-Fi, which allows the test results to be sent securely to the hospital’s recording system.
Testing for this study took place between April 10 and May 12 at three NHS locations: St. Mary’s Hospital, Imperial College Healthcare NHS Trust, London; Chelsea Hospital and Westminster NHS Foundation Trust, London and John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford.
Dr Bob Klaber, director of strategy, research and innovation at the Imperial College Healthcare NHS Trust, said. “As an organization, we are focused on using research and innovation to drive continuous improvement in care. It has been brilliant 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 evaluate the practicality and validity of this exciting test. Getting accurate results as quickly as possible from clinicians and their patients makes a huge difference in the way we safely manage clinical pathways and look forward to disseminating it more widely. ”
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Provided by Imperial College London
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