First Breath Test for Covid Approved by FDA

We are now in year three of the pandemic. When the virus first started to make headlines, it was a mystery. Then it became a global threat. But, in a shockingly short amount of time, researchers have made huge leaps in diagnosing, preventing and treating Covid-19.

The FDA granted emergency use authorization for a Covid-19 breath test. The InspectIR Covid-19 Breathalyzer is almost 100 percent accurate in spotting a negative result and more than 91 percent correct in diagnosing people as positive. Meaning if it says a person is negative, they are, and if it says a person is positive, they almost certainly are. That is considered highly accurate. It’s authorized for use on people above the age of 18.

It works by detecting five chemical compounds in the breath associated with the virus. The test isn’t something you would use at home. The InspectIR Covid-19 Breathalyzer is the size of a carry-on suitcase. It could be used at testing sites, hospitals and doctors’ offices. It has the benefit of giving results in under three minutes. But it does require a trained health professional to operate the machine.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said that the test’s authorization “is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19. The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency.”

The company that makes the InspectIR Covid-19 Breathalyzer can produce 100 of the machines a week. Each device can be used about 160 times a day.

At this level of production, testing capacity using the InspectIR Covid-19 Breathalyzer is expected to increase by approximately 64,000 samples per month,” said the FDA.

Philadelphia has brought back mask mandates for indoor public spaces as new surges have made its health officials feel it was necessary. Better, faster, more accurate and more accessible testing is one tool in fighting the spread of the virus. When people know they are infected, they can do everything to avoid spreading it to others.

Moreover, with the subvariants of omicron spreading around, it underscores the need to be prepared for what’s next. Breakthroughs made now could “future-proof” against other breakouts. And, at-home tests are being developed for Covid-19 that could someday be used to detect the flu with a single swab. These medical advancements could make flu season safer in the future.  

Image: InspectIR Systems, LLC

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