The US Food and Drug Administration said Thursday that the first Covid-19 test, which detects chemical components linked to the coronavirus in-breath, has been given emergency use authorization.
The inspection Covid-19 Breathalyzer, which is roughly the size of a carry-on suitcase, can be utilized in medical offices and mobile testing facilities, according to the FDA. It can produce results in just three minutes.
To detect five molecules linked to SARS-CoV-2 infection, the technology separates and detects chemical combinations.
According to research, the InspectIR Breathalyzer correctly recognized more than 91% of positive samples and nearly 100% of negative samples.
Another study focused on the Omicron coronavirus subtype and found similar sensitivity. According to the FDA, a positive result should be validated with a PCR test.
In a statement, Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said, “Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”
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“With the goal of advancing technology that can assist address the present pandemic and better prepares the United States for the next public health emergency, the FDA continues to support the development of innovative COVID-19 tests.”