FDA Grants EUA to COVID Screening Device for Asymptomatic People
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The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for a screening device that identifies biomarkers that may indicate asymptomatic SARS-CoV-2 infection in people ages 5 and older.
The Tiger Tech COVID Plus Monitor (Tiger Tech Solutions, Inc) is designed for use after a temperature reading indicates no fever in settings where temperature checks are being performed in accordance with federal and local infection prevention and control guidelines, the FDA said.
“Combining use of this new screening device, which can indicate the presence of certain biomarkers, with temperature checks could help identify individuals who may be infected with the virus, thus helping to reduce the spread of COVID-19 in a wide variety of public settings, including healthcare facilities, schools, workplaces, theme parks, stadiums, and airports,” Jeff Shuren, MD, director of the FDA Center for Devices and Radiological Health, said in a statement.
This device is for use by trained personnel, is not a substitute for a COVID-19 diagnostic test, and is not for use in people with symptoms of COVID-19, the agency said.
The armband device has embedded light sensors that obtain biometric signals from the body over 3 to 5 minutes. Once complete, a small computer processor extracts key features of the signals, such as pulse rate.
This information is fed into a probabilistic machine-learning model trained to predict whether the person is showing potential signs of infection, such as hypercoagulable state (which is often seen in COVID-19 patients) or hyperinflammatory states (such as severe allergic reactions).
The results are given in color-coded lights used to indicate if an individual is demonstrating certain biomarkers, or if the result is inconclusive.
The clinical performance of the device was validated in a hospital setting of 467 asymptomatic individuals, including 69 confirmed positive SARS-CoV-2 cases.
In this study, the device achieved 98.6% positive percent agreement (proportion of COVID-19 positive individuals correctly identified to have certain biomarkers) and 94.5% negative percent agreement (proportion of COVID-19 negative individuals correctly identified not to have the biomarkers).
A confirmatory study conducted in school settings showed similar performance.
More information on the device is available online.
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