Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”
The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider.
The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples. “InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”
Brasil Últimas Notícias, Brasil Manchetes
Similar News:Você também pode ler notícias semelhantes a esta que coletamos de outras fontes de notícias.
FDA authorizes first Covid-19 breath testThe US Food and Drug Administration has granted emergency use authorization to the first Covid-19 test that spots chemical compounds associated with the coronavirus in breath, the agency said Thursday.
Consulte Mais informação »
FDA authorizes 1st breath test for COVID-19 infectionCOVID BREATH TEST: The Food and Drug Administration on Thursday issued an emergency use authorization for what it said is the first device that can detect COVID-19 in breath samples.
Consulte Mais informação »
FDA Authorizes First COVID-19 Breath TestThe Food and Drug Administration on Thursday authorized the first COVID-19 test that uses breath samples.
Consulte Mais informação »
FDA authorizes first breath test to detect COVID-19The FDA has granted emergency use authorization to the first Covid-19 test that spots chemical compounds associated with the coronavirus in breath, the agency said.
Consulte Mais informação »
FDA Authorizes First Covid-19 Breath TestThe FDA said the InspectIR Covid-19 Breathalyzer, which is about the size of a piece of carry-on luggage, can be used in medical offices and mobile testing sites. It can give results in less than three minutes.
Consulte Mais informação »