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September 18, 2020 5:21:56 pm
The test is currently being used with success in eight London hospitals and will be implemented nationwide in the UK as data from the test device continues to be collected for ongoing evaluation. (Figurative)
A new small box COVID-19 rapid test device, which gives results in 90 minutes, has been found to have a high level of precision and produced very few false negatives and no false positives in a UK study.
Lab-in-Cartridge tests can be performed on cartridges smaller than a mobile phone and do not require a laboratory.
The study, led by scientists at Imperial College London and published in ‘The Lancet Microbe’ this week, involved high-speed tests on 386 National Health Service (NHS) employees and patients and found to have more than 94 percent sensitivity and 100 percent specificity.
“These results suggest that the test, which can be performed at the bedside of a patient without the need to manipulate any sample material, has a precision comparable to standard laboratory tests,” said Professor Graham Cooke, lead author. from the study of the Department of Infectious Diseases at Imperial College London.
“Many tests involve a compromise between speed and precision, but this test achieves both. Developing an effective bedside test in less than three months has been an incredible collaboration between teams of engineers, physicians and virologists, ”he said.
The test is currently being used successfully in eight London hospitals and will be rolled out nationwide in the UK as data from the test device continues to be collected for ongoing evaluation.
Imperial College London said the UK government recently placed an order for 5.8 million test kits.
To perform the test, a pediatric-sized nasal swab from a patient is inserted into the device, which then looks for traces of genetic material belonging to SARS-CoV-2 or the novel coronavirus, causing the infection.
A result is available in 90 minutes, compared to conventional COVID-19 tests that provide a result in 24 hours.
According to the research team, the test is now being developed to simultaneously test for influenza A, influenza B, and RSV, as well as COVID-19.
The device, produced by London-based Imperial start-up DnaNudge, was used on 280 NHS staff with suspected COVID-19, 15 Accident and Emergency (A&E) patients with suspected COVID-19 and 91 patients. hospitalized, some of whom showed no symptoms of COVID-19.
The percentage of those who tested positive for COVID-19 during the study at the peak of the pandemic was 18 percent.
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, representing the value of 94 percent sensitivity.
“The DnaNudge test was developed as an on-site, lab-free consumer service that can be delivered at scale, so we clearly believe that it offers very significant potential in terms of mass population testing during the Covid-19 pandemic.” said Regius Professor Chris Toumazou, CEO and co-founder of DnaNudge and founder of the Institute of Biomedical Engineering at Imperial College London.
“The platform is suitable for testing in community and primary care settings with the potential for use in non-healthcare settings, such as nursing homes, schools, transportation hubs, offices, and to help restore the arts in theaters and venues. However, more real-world efficacy studies in non-clinical settings would be needed before widespread implementation, ”he said.
The research team, which included scientists and physicians from Imperial and various NHS hospital trusts, evaluated sensitivity and specificity.
Sensitivity is a measure of how well a test is positive for people who have the disease and is an indication of how likely a test is to produce 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 probability of false positive results.
“As an organization, we are focused on using research and innovation to continually drive improvements in care. Getting accurate results for physicians and their patients as quickly as possible makes a huge difference in how we safely manage clinical pathways. and we are very looking forward to the future. ” to implement this more widely, ”said Dr. Bob Klaber, director of strategy, research and innovation at Imperial College Healthcare NHS Trust.
The device has been approved by the UK Health and Medicines Regulatory Agency and has also been CE marked, allowing for further use in non-clinical locations. The team explains that each device is Wi-Fi-enabled, allowing the test result to be sent securely to a hospital’s record system.
Testing for the study took place between April 10 and May 12 at three NHS sites: St Mary’s Hospital, Imperial College Healthcare NHS Trust, London; Chelsea & Westminster Hospital NHS Foundation Trust, London and John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford.
It was supported by the National Institute for Health Research, Imperial Biomedical Research Center.
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