As fact that “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 agency’s last step today was to grant emergency use authorization to a new COVID-19 test that can detect infections with only a sample of a patient’s breath, using a device that can yield results in less than three minutes. According to InspectIR, the test is performed by exhaling into a tube in a similar manner to blowing up a balloon. However, for the instant, the InspectIR COVID-19 Breathalyzer will only be available for tests “by a qualified, trained operator under the supervision of a health care provider,” being designed for use in hospitals, doctors offices or mobile testing sites. InspectIR’s test works by analyzing a person’s breath using “gas chromatography gas mass-spectrometry.
When it detects the presence of infection, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test. “During tests, the system produced false positives in only 0.7% of results. The testing instrument is about the size of a piece of carry-on luggage. Approximately 100 instruments units can be produced in a week. Testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month. The producer is not releasing at this moment the price of the machine or when it will be available. Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”
