It can detect infection with a small sample of patient’s breath and can be performed using a device that takes less than three minutes to produce results.
According to the agency, the InspectIR COVID-19 breathalyzer can only be used by a trained operator who is qualified and under the supervision of a healthcare provider.
“The FDA continues support the development COVID-19 test with the goal to advance technologies that can help address this pandemic and better position U.S. for next public health emergency,” said Dr. Jeff Shuren (FDA’s top COVID-19 testing official) in a statement.
This test is intended for hospitals, doctors offices, and mobile testing sites. It requires equipment that is about the same size as a piece luggage. According to the FDA, the company can produce approximately 100 instruments per week. Each test can assess around 160 samples per day.
InspectIR’s test uses “gas chromatography gas-mass-spectrometry” to analyze a person’s breathing and detect five compounds that are commonly exhaled by people infected with SARS-CoV-2.
The FDA found that the device could detect 91.2% of patients with symptoms and only 0.7% of false positives. Although the company has announced that it will begin clinical trials in 2020 the FDA claims that a follow-up study found similar accuracy in detecting Omicron variants.
According to InspectIR’s website the company has used similar technology to detect drugs in peoples’ breaths.
According to COVID, the company’s COVID breath test can be used to screen employees as they return to work. It is less invasive than the traditional swabs that are used for most other tests.
Our device(s), in less than three (3) minutes can determine if someone is actively infected. If so, they will prevent them from entering/admissioning a facility. In a 2021 post, the company’s president stated that understanding if people are healthy enough to be there “right now” is the only way to create a safety protocol.
Similar to the popular at home COVID-19 test, FDA states that positive breathalyzer results “should be confirmed by a molecular test.”
The FDA has approved other methods to test for the presence of the virus. In August 2020, the FDA authorized a Yale test that tested for the presence of the virus using saliva samples. An antibody test was approved by FDA last year using a finger poke.
Federal government also supported the development a variety of COVID-19 test types, including at-home kits that could one day allow you to test for COVID-19 and flu with just one swab.
Shuren stated, “Today’s approval is yet another example the rapid innovation occurring in diagnostic tests for COVID-19.”
