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US Grants Emergency Use Authorization for COVID-19 Respiratory Test Machine

The FDA licensing review demonstrates the rapid progress in the development of test methods for the detection of COVID-19.

On April 14, the US Food and Drug Administration (FDA) approved the emergency use of the first nationally developed COVID-19 diagnostic test machine.

This testing machine detects chemicals in the breath that appear when the body is infected with the SARS-CoV-2 virus.

Testing can be done in doctor’s offices, hospitals, and mobile testing stations where samples can be collected and tested. Results will be available in 3 minutes.

[Perspective of the breath test to detect traces of SARS-CoV-2]

The trial, called the COVID-19 Experimental Ventilator, was shown to be effective in a large study of 2,409 participants, including people with the disease with and without symptoms.

Test results show that this tester has a sensitivity of 91.2% and a clarity and accuracy of 99.3%.

The FDA licensing review demonstrates the rapid progress in the development of test methods for the detection of COVID-19.

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