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FDA authorises breath test to detect COVID-19 in three minutes

A breath test that can pick up COVID-19 infections in patients in less than three minutes has been granted emergency use authorisation by the US Food and Drug Administration (FDA).

The agency says the InspectIR COVID-19 Breathalyzer will be available for tests only “by a qualified, trained operator under the supervision of a health care provider”.

CBS News reports that the test, designed for use in hospitals, doctors’ offices or mobile testing sites, requires a piece of equipment about the size of a piece of carry-on luggage. The FDA says the company will be able to produce around 100 instruments weekly. Each test can evaluate around 160 samples a day.

It works by analysing a person’s breath using gas chromatography gas mass-spectrometry to detect five compounds typically exhaled when people are infected by SARS-CoV-2.

In a study of 2,409 people with and without symptoms, the FDA says the device detected 91.2% of cases – and yielded false positives in only 0.7% of results. The company announced initial clinical trials back in 2020, though the FDA says a follow-up study also found the tests had similar accuracy at detecting the Omicron variant.

While most COVID-19 tests rely on swabs, the FDA has green-lighted other alternatives seeking signs of the virus. In August 2020, the agency authorised a test from Yale University that looked for infection using saliva samples. Last year, an antibody test earned the FDA’s emergency authorisation using a finger prick.

 

CBD News article – FDA authorizes breath test that can detect COVID-19 in three minutes (Open access)

 

See more from MedicalBrief archives:

 

Saliva can be more effective than nasopharyngeal swabs for COVID-19 testing

 

UK statisticians: 'Spiking' of COVID-19 saliva tests is distorting claimed accuracy

 

Detection efficacy of self-collected saliva and deep nasal swabs — large US study

 

Saliva-based COVID-19 diagnostic test given FDA emergency use authorisation

 

 

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