First-of-its-Kind Breath Test Approved in US to Detect COVID-19

” said Cristina Davis, the associate vice chancellor of Interdisciplinary Research and Strategic Initiatives at the University of California, Davis, who has been developing her own COVID-19 test. She also said, “

The company claims that the InspectIR COVID-19 breathalyzer is only available for testing “by a qualified, trained operator under the supervision of a health care provider.”

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,” as told by Dr. Jeff Shuren, the FDA’s top COVID-19 testing official, said in a statement announcing the authorization.

Some COVID-19 breath tests have already been tested in pilot programs or approved for use in other countries, but the InspectIR breathalyzer will be the first to hit the market in the United States.

The test, designed for use in hospitals, doctors’ offices, or mobile testing sites, requires a device around the size of a piece of carry-on luggage. The FDA says the company can produce about 100 tools a week. Each test can evaluate approximately 160 samples each day.

Shuren has also said, “Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.

InspectIR’s test is performed by analyzing a person’s breath with “gas chromatography gas mass-spectrometry” to detect five compounds that are commonly excreted when people are infected with SARS-CoV-2.

The FDA says the device was able to detect 91.2% of cases in a study of 2,409 people with or without signs — and gave only 0.7% false positive results.

The company has announced that COVID-19 breath tests will resume clinical trials in 2020, although the FDA has found in a follow-up study that the tests have similar accuracy in detecting Omicron variation.

InspectIR will use similar technology in other tests to detect drugs in people’s breath, according to the company’s website. The company claims that its COVID-19 breath test can be used to screen employees returning to the office one day, using a less aggressive process than most tests currently rely on.

In less than three (3) minutes, our device(s) can tell if a person may be actively infected and precluded from entrance/admission to a facility. The only way to ensure a true safety protocol is to understand if people are well enough to be there ‘right now,’” the company’s president wrote in a 2021 post.

Scientists have noted that some foods and substances can throw up breath tests. The instructions for the InspectIR breathalyzer state that people should not eat, drink, or consume any tobacco products for 15 minutes before the test. They also said that those who test positive should confirm the result with PCR or other similar testing.

Similar to the rapid COVID-19 tests that have become popular in recent months, the FDA says the positive results of a newly authorized breathalyzer must be “confirmed by molecular testing”.

While most COVID-19 tests rely on swabs, the FDA has given the green light to other alternatives to detect symptoms of the virus. In August 2020, the agency approved a test to diagnose the infection using saliva samples from Yale. Last year, an antibody test received emergency approval from the FDA using finger prick.

The federal government has supported the development of a series of new types of COVID-19 tests, including home-based devices that can one day test for influenza and COVID-19 infections with a single swap.

Source: Medindia

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