The U.S. health authority has approved for the first time a test device that checks whether a person is infected with COVID-19 by breathing like a breathalyzer.
The New York Times and CNN reported on the 14th (local time) that the US Food and Drug Administration (FDA) has approved the emergency use of the ‘Inspect IR Corona 19 Respirometer’.
This device breathes out like a breathalyzer for 10 seconds. Distinguish and identify 5 compounds related to COVID-19 during exhalation.
Test results are available within 3 minutes. If a positive result is obtained here, the final confirmation should be done through PCR test.
The size of a carry-on suitcase, it can be installed in a medical facility or mobile testing station. One device can perform about 160 tests per day. Manufacturers can produce 100 pieces of equipment per week, which could result in about 64,000 tests per month, the FDA predicts.
According to the FDA, the device correctly identified 91% of positive samples and 99% of negative samples in a study of 2409 people.
However, because a negative test does not completely rule out infection, the patient’s exposure to infection, history, and symptoms must be considered, and the FDA said that this equipment should not be the only criterion for determining a patient’s treatment or condition.
“Today’s approval is another example of rapid innovation in testing for COVID-19,” an FDA official said.