FDA Authorizes First Breath Test for Covid Infections

You may soon be able to tell if you have Covid by simply breathing into a Breathalyzer. 

The Food and Drug Administration issued an emergency use authorization for what it says is the first device yet to detect Covid in breath samples. 

Nearly 100 percent of negative samples were properly detected, and just over 91 percent of positive ones were properly detected. It reportedly is 91.2 percent accurate at identifying positive test samples, and 99.3 percent accurate at identifying negative results. 

The InspectIR Covid-19 Breathalyzer can be used in hospitals, doctor’s offices, and mobile testing. The device is about the size of a piece of carry-on luggage or a large briefcase. The test can provide results in under three minutes. 

The FDA’s Center for Devices and Radiological Health Director Dr. Jeff Shuren said that the device was another example of rapid innovation happening with Covid testing. 

The test will not soon be coming to your home, nor to public spaces like bars, restaurants, hotels and airports. This is because the test needs to be carried out under the supervision of a licensed healthcare provider. 

The FDA said that InspectIR will be able to produce about 100 instruments a week, which can take about 160 samples a day. Testing capacity is expected to increase by approximately 64,000 samples a month. 

The test spots chemical compounds associated with Covid, separating and identifying chemical mixtures to detect the compounds. 

Experts are saying that while the new Breathalyzer test may not completely rule out the need for nose tests, it will rule out cases, which is a big step forward. Most likely, the test will either return a confirmed negative result, or an unconfirmed or unofficial positive. If positive, that person will likely then have to be confirmed positive with a PCR test. 

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