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FDA’s green signal to a noval screening device to recognize possible biomarkers indicative of COVID-19

FDA’s green signal to a noval screening device to recognize possible biomarkers indicative of COVID-19 FDA’s green signal to a noval screening device to recognize possible biomarkers indicative of COVID-19
FDA’s green signal to a noval screening device to recognize possible biomarkers indicative of COVID-19 FDA’s green signal to a noval screening device to recognize possible biomarkers indicative of COVID-19

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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.

Source:

FDA

Article:

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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