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A non-diagnostic screening device may now be used to
recognise biomarkers pertaining to COVID infection in specific asymptomatic
people without fever.
The first machine learning-based screening tool for COVID-19
was granted EUA status i.e. the
emergency use authorization by the FDA on 19th March, 2021.
This tool may help recognize particular biomarkers suggestive of some types of
disorders, for example hypercoagulation, commonly
observed in COVID-19 patients.
This COVID Plus Monitor is anticipated for use by trained
professional to avoid exposure to and spread of COVID-19 infection. This tool
recognizes specific biomarkers that may be indicative of COVID infection and
other hypercoagulable or hyperinflammatory conditions in people without
symptoms and aged over 5 years.
It should be noted that- this device is not an alternative
for a COVID-19 diagnostic test and not to be used in people with COVID-19
symptoms.
The device has an armband wrapped around an individual’s
undressed left arm above the elbow and a miniature computer processor to
display numerous colored lights indicative of certain biomarkers or if it is an
incorrect screening result.
The clinical performance of this device was planned in
hospital and school situations. The hospital study (validation study)
registered 467 asymptomatic people, plus 69 positive cases. A 98.6% positive percent agreement and a 94.5%
negative percent agreement were found. The school study (confirmatory study)
had similar outcomes.
FDA
Coronavirus (COVID-19) Update: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection
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