In a bid to improve COVID-19 screening, the FDA has recently approved a machine-learning device that can detect disease biomarkers in asymptomatic patients. This device is set to be used in public places along with routine temperature checks to help prevent further spread.
Asymptomatic COVID Patients
Many COVID-19 patients remain asymptomatic. This means that, on the surface, they do not show any signs of having the infection. Not even the hallmark fever. This is a serious issue because such people won’t know that they have the disease and will not isolate themselves. They may also enter public places, risking exposure to others.
A Machine-Learning Device
Made by Tiger Tech solutions, the COVID plus monitor can screen asymptomatic patients who don’t show signs of fever. It is a non-invasive screening device that can help detect certain invisible biomarkers to confirm the presence of the disease.
“Combining use of this new screening device, that 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, M.D., J.D., director of FDA’s Center for Devices and Radiological Health
The monitor consists of an armband with sensors and a computer processor which employs a machine-learning model. Using the sensors, the device detects pulsatile signals as blood flows in the veins. It completes measurement within three to five minutes, after which the processor analyses the data to compare the biomarkers and recognize signs that confirm the presence of COVID, such as hypercoagulation in blood.
Prior to FDA approval, Tiger-tech held two trials to test the monitor’s efficacy. The first, a hospital study, studied 467 asymptomatic individuals, 69 of which tested positive for COVID. The result showed that the monitor correctly detected 98.6% of the positive patients and 94.5% of the negative patients. A confirmation study held at a school showed a similar result.
While the FDA has approved this device for emergency use in public places in conjunction with temperature screening, they caution that it is not a diagnostic test. This is because an individual’s underlying condition may interfere with the device’s performance, leading to an incorrect result.