Washington DC: The Food and Drug Administration has authorised a first-of-its-kind test that detects coronavirus using breath samples. The agency says the test delivers results within three minutes, but cautioned that it would fail to detect nearly one in 10 positive cases.
The InspectIR COVID-19 Breathalyser, which is about as big as a piece of carry-on luggage and was designed by Frisco, Texas-based InspectIR Systems, requires test subjects to blow into a straw attached to the device for up to 10 seconds.
The InspectIR COVID breathalyser gives fast results, but has to be administered by a trained operator.
According to the US’ chief medical approvals agency, the breath test detected 91 per cent of positive cases and more than 99 per cent of negative cases in a trial of about 2,400 patients, putting its performance roughly on par or better than at-home nasal swab tests. But unlike at-home tests, the breath test must be administered by a trained operator.
People who test positive using the breath test should then get a second, confirmatory PCR test, the agency said.
Experts said that the breath test could eventually be used as a quick screening device at large events, given its ease-of-use and quick turnaround time compared to rapid tests that often require at least 15 minutes to wait for results.
“It looked good, not great, in terms of sensitivity,” said former agency commissioner Scott Gottlieb. “So good enough as a belt-and-suspenders if you want to have an extra layer of protection at an event like the Gridiron Dinner,” he added, referring to a gala held earlier this month in Washington DC, which resulted in dozens of infections.
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Since authorising the InspectIR Breathalyzer on Thursday last week, the agency has received many inquiries about the device’s potential to be used at large events, said an agency official, speaking on condition of anonymity to discuss agency inquiries.
Officials also said that a noninvasive approach to coronavirus testing could expand the pool of people willing or able to be tested, but cautioned that the breath test is unlikely to be widely adopted in the near future. InspectIR plans to produce only about 100 systems per week, whereas manufacturers of other kinds of coronavirus tests, such as nasal swabs, have produced millions of devices in recent months.
US authorises coronavirus breath test with results in three minutes
Source: Philippines Alive
