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Rapid 90-Minute COVID-19 Test Shown to Be Highly Accurate


The blue circular CovidNudge cartridge in the NudgeBox analyzer. Photo credit: Thomas Angus / Imperial College London

A 90 minute COVID-19 In a new study it was shown that the test has a sensitivity of over 94 percent and a specificity of 100%.

A new study showed that a 90-minute COVID-19 test had a sensitivity of over 94 percent and a specificity of 100 percent.

The work, published in the journal The Lancet Microbe, was conducted by scientists Imperial College London. In the research, the high-speed tests, which do not require a laboratory and can be performed in cartridges smaller than a cell phone, were conducted 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%, which means that it has a high level of accuracy and produced very few false negatives and no false positives.

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 patient SARS-CoV-2 Virus that causes COVID-19.

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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 to simultaneously assess Flu-A, Flu-B and RSV as well as COVID19.

Professor Graham Cooke, lead author of the study at Imperial’s Infectious Diseases Division, 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 manages 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 all people in the study were analyzed using both the rapid test device known as the CovidNudge test and standard hospital laboratory equipment, 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 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 an indication of the likelihood of false positive results.

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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 67 samples tested positive in the CovidNudge test, compared to 71 positive results against a range of standard NHS laboratory machines, representing a value of 94 percent sensitivity. The study was supported by the National Institute for Health Research of the 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 that can be delivered on a large scale. We therefore firmly believe that that it offers very great potential for mass population testing during the COVID-19 pandemic. The platform is well suited for primary and community testing with potential for use in non-healthcare settings such as nursing homes, schools, transportation hubs, offices and, to bring the arts back, in theaters and venues. However, more actual efficacy studies in non-clinical settings would be required before widespread use. ”

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 Medicines and Health Authority).

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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’s Hospital, Imperial College Healthcare NHS Trust, 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, we focus 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 evaluate the practicality and validity of this exciting test. Getting accurate results back to physicians and their patients as quickly as possible has a huge impact on how we safely manage clinical pathways and we look forward to expanding them further. ”

Reference: September 18, 2020, The Lancet Microbe.

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