The U.S. Food and Drug Administration (FDA) said it has granted emergency use authorization to the first COVID-19 diagnostic test to detect chemical components in breath samples linked with a SARS-CoV-2 infection.
FDA Authorizes First COVID Breath Testing Device
The FDA said on Thursday, April 14, that the "InspectIR COVID-19 Breathalyzer," the first COVID-19 diagnostic test to detect chemical components in breath samples linked with a SARS-CoV-2 infection, has received an emergency use authorisation (EUA) from the agency.
This means that the InspectIR COVID-19 Breathalyzer, which is about the size of a piece of carry-on luggage, can be used in environments where the patient specimen is both collected and analyzed, such as in medical offices and mobile testing sites. It can produce results in just three minutes.
The test is administered by a qualified, trained operator under the supervision of a health care provider who is licensed or permitted by state law to prescribe tests.
The breathalyzer correctly identified positive samples 91.2% of the time and negative samples 99.3% of the time in a study of 2,409 people. CNN mentioned that similar sensitivity was found in another study that focused on the Omicron coronavirus variant. However, it was noted that a positive result should be confirmed with a PCR test.
How Can the InspectIR COVID-19 Breathalyzer Determine Positive and Negative Test Results?
FDA said that the InspectIR COVID-19 Breathalyzer employs a technique called gas chromatography gas mass spectrometry (GC-MS) to separate and identify chemical mixtures, as well as rapidly detect five Volatile Organic Compounds (VOCs) linked with SARS-CoV-2 infection in exhaled breath.
When the SARS-CoV-2 VOC markers are detected by the InspectIR COVID-19 Breathalyzer, a presumptive (unconfirmed) positive test result is returned, which should be confirmed with a molecular test.
Negative results should be viewed in the context of a patient's recent exposures, medical history, and the existence of COVID-19-like clinical signs and symptoms. FDA noted that this is because they don't rule out SARS-CoV-2 infection and shouldn't be relied on solely for treatment or patient management decisions, including infection control.
How Many Samples Can a Single InspectIR COVID-19 Breathalyzer Evaluate in a Day?
InspectIR aims to be able to create around 100 instruments per week, each capable of evaluating around 160 samples per day. FDA said that the testing capacity for the InspectIR COVID-19 Breathalyzer is estimated to rise by roughly 64,000 samples per month at this level of production.
Other COVID-19 Breathalyzer Technology
NASA said, on a news release on April 7, 2021, that the Department of Health and Human Services has provided NASA with $3.8 million to improve the E-Nose device developed at NASA's Ames Research Center in California's Silicon Valley using patented nanosensors and nanosensor array technologies for COVID-19 detection.
E-Nose is a smartphone-based gadget that NASA is developing to detect COVID-19 by "sniffing" a person's breath.
In a similar way that temperature checks are used to screen individuals before entering shared indoor places like a local grocery shop or restaurant, E-Nose could help minimize the communal spread of the virus.
