The US approved the Covid-19 test machine through the first breath, with results in 3 minutes
In a notice posted on its homepage on April 14, the FDA said it has granted an emergency use authorization (EUA) for the diagnostic test. Covid-19 the first method to detect chemical substances in breath samples related to SARS-CoV-2 infection.
Many manufacturers have launched Covid-19 breathing testing devices, but this is the first time the FDA has approved a device – Illustration from TIME OF ISRAEL
“Testing can be performed in any environment such as clinics, hospitals and mobile testing sites, collecting and analyzing specimens at the same time, using an instrument the size of a piece of luggage. Addiction testing should be performed by a qualified, trained person, under the supervision of a health care provider authorized or authorized by law,” the FDA wrote in the announcement.
The performance of the Covid-19 breathalyzer was confirmed in research based on 2,409 individuals. The meter gives results within 3 minutes and has a sensitivity of up to 91.2% (percentage of positive samples correctly identified by the test) and specificity of 99.3% (percentage of negative samples correctly identified). corpse).
The test was equally sensitive in a follow-up study focusing on the Omicron variant.
The Covid-19 breathalyzer uses gas chromatography-mass spectrometry (GC-MS) to separate and identify chemical mixtures, and quickly detects 5 related volatile organic compounds. to SARS-CoV-2 infection in the breath.
FDA recommends that positive results returned from this device be further confirmed by molecular biology (PCR); while a negative test may be considered based on epidemiological factors.
The company that manufactures the VerifyIR machine is expected to be able to produce about 100 devices per week, each of which can evaluate 160 samples per day, helping to generate a testing capacity of 64,000 samples per month.
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