"Now, just a 'Hoo~' blow reveals COVID-19 infection status within 3 minutes"…No need to poke the nose

FDA Grants Emergency Use Authorization for InspectIR COVID-19 Breathalyzer

New COVID-19 diagnostic testing equipment granted emergency approval by the FDA on the 14th. / Photo by InspectIR Systems website capture

[Asia Economy Reporter Na Ye-eun] A device that can determine COVID-19 infection within 3 minutes by blowing out breath has received approval from the U.S. Food and Drug Administration (FDA) for the first time.

On the 14th (local time), according to CNN and The New York Times, the U.S. FDA announced in a statement that it had approved the emergency use of the 'InspectIR COVID-19 Breathalyzer,' a test device that can diagnose coronavirus from breath samples.

This device does not require collecting samples by inserting a swab deep into the nose like existing rapid antigen tests for COVID-19. Instead, by holding a long straw-like tube resembling a breathalyzer and exhaling for about 10 seconds, the infection status is determined within 3 minutes.

The testing device uses a technology called gas chromatography-mass spectrometry, which distinguishes and identifies five chemical compounds related to COVID-19 among the chemical components contained in a person's breath.

The FDA explained that the diagnostic accuracy of this device was verified in a large-scale study. Among 2,409 people with and without COVID-19 symptoms, the test accurately identified 91% of COVID-19 positives and 99.3% of negatives. A separate study focusing on the Omicron variant showed similar accuracy.

Professor Yvonne Maldonado of Stanford University School of Medicine said, "The original test (which collects samples from the nose) was quite unpleasant. The easier the diagnosis becomes, the better our lives will be."

The manufacturer, InspectIR, stated that it can produce about 100 units of this device weekly and that each device can conduct 160 tests per day. The FDA estimates that if commercialized, approximately 64,000 tests could be conducted monthly using this device.

The device, about the size of a carry-on suitcase, can be installed and used in hospitals, clinics, or mobile COVID-19 testing sites. However, the FDA noted that if a positive result is obtained with this breathalyzer, a confirmatory test using polymerase chain reaction (PCR) must be conducted.

An FDA official said this testing method is the first of its kind and added, "Today's approval is another example of rapid innovation related to COVID-19 diagnostic testing," and "The FDA will continue to support the development of new COVID-19 testing methods."

This content was produced with the assistance of AI translation services.