The Food and Drug Administration granted emergency-use
authorization to the first
COVID-19 test that can detect the coronavirus in a
breath sample, within minutes and with a high degree of accuracy, the agency
said Thursday.
اضافة اعلان
“Today’s authorization is yet another example of the rapid
innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, director
of the FDA’s Center for Devices and Radiological Health, said in a statement.
The InspectIR COVID-19 Breathalyzer, which is about the size of
a piece of carry-on luggage, can produce results in less than 3 minutes and can
be used in doctor’s offices, hospitals and mobile testing sites by trained
operators. A single machine can analyze about 160 samples per day.
Yvonne Maldonado, an infectious disease specialist at Stanford
University School of Medicine who is working on another Breathalyzer test, said
that having more options to test will only help the transition to the endemic
phase of the pandemic.
“If you think back from the original PCR, those were pretty
horrible,” Maldonado said. “They were very uncomfortable and seemed to last
forever — the easier we can make it, the better off we are.”
The device was tested in a study made up of 2,409 individuals
both with and without symptoms of the virus. In the study, the test identified
91% of positive samples correctly and 99% of negative samples correctly.
The Breathalyzer test uses a technique called gas chromatography
gas mass-spectrometry, which separates and identifies chemical mixtures to
detect five compounds associated with the coronavirus in exhaled breath. If a
test comes back positive on the Breathalyzer, it should be confirmed with a
molecular test, such as a PCR lab test.
The FDA warned that negative tests “should be considered in the
context of a patient’s recent exposures, history and the presence of clinical
signs and symptoms consistent with COVID-19” because they do not completely
rule out an infection, and noted that the device “should not be used as the
sole basis for treatment or patient management decisions, including
infection-control decisions.
InspectIR, the company that produces the Breathalyzer, expects
to be able to produce about 100 machines per week.
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