COVID breath test: fascinating technology, limited potential?

April 15, 2022 – A first-of-its-kind test that detects coronavirus in the breath could provide results in less than 3 minutes, but the real-world impact could be limited.

The test, from InspectIR Systems, delivers results faster than the 15 minutes required for existing COVID-19 rapid tests – and represents a leap forward in testing technology.

The FDA granted emergency use approval for the test Thursday, which will be available in licensed facilities. But the COVID-19 breath test is not intended for home use.

That’s one reason the effects of the test may be limited, says William Schaffner, MD. The manufacturer says it can produce about 100 test instruments a week, and “it’s not like they’re producing 10,000,” he says.

Capacity is also limited: each test system can evaluate 160 breath samples per day.

“So this can’t be used at a concert or a big ball game or anything like that,” said Schaffner, a professor of medicine at Vanderbilt University Medical Center in Nashville.

It is more likely that the COVID-19 breath test will be used in “an average doctor’s office or clinic … a circumstance where the capacity of the machine would be appropriate.”

New technology

“Today’s authorization is yet another example of the rapid innovation happening with diagnostic testing for COVID-19,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in a press release.

“The FDA continues to support the development of new COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the US for the next public health emergency,” he said. .

The new technology is “fascinating,” Schaffner says. “It’s a new diagnostic advancement. There are some very smart people out there making better vaccines, therapeutics and diagnostic tests.”

The breath test was evaluated in a study involving 2,409 people, including those with and without COVID-19 symptoms.

The test accurately identified 91.2% of the positive samples and 99.3% of the negative samples, so it is very sensitive and specific.

A negative result means people are likely to be really negative, as the test had a negative predictive value of 99.6%, the FDA notes. People who test positive should consider using a lab test to confirm the result. In a separate study specific to the Omicron variant, the performance of the test was comparable.

The research that led to the EUA “certainly seems very rigorous,” Schaffner says.

Unanswered questions

“How much training does one actually take to do this?” asked Schaffner.

It takes someone with a testing license to oversee the testing – therefore this is not a home test – as well as a technician trained and competent to perform the test and interpret the results.

Schaffner added, “We’ll just have to see how well it works in the real world.”

It remains unknown how much the breath test will cost, whether insurance is likely to cover all or the cost, and when the test is likely to be available in hospitals, doctors’ offices, or mobile testing sites. Questions to the manufacturer were not answered by publication time.

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