We’ve known for years that the coronavirus that causes COVID-19 can travel with every breath we take. Now, for the first time, the FDA has given the green light to a test that can detect COVID-19.
A handheld breathalyzer developed by InspectIR Systems is said to provide a result in three minutes by looking for exhaled chemicals that can lead to infection.
The device contains its miniature mass spectrometer, reduced to about the size of a suitcase. It is intended for use under the supervision of healthcare professionals in locations such as doctor’s offices, hospitals, and mobile testing centers.
By blowing into a tube connected directly to the machine, the inspection test looks for five specific volatile organic compounds produced by the body in the fight against COVID.
Although positive results must be confirmed with a secondary PCR test, the FDA said negative results from the device could be accurate enough to be used in expanded screening settings when placed in the context of exposure to people who have died recent history and its current signs and symptoms.
In a large study of more than 2,400 people with or without symptoms, emergency clearance was granted after a breathalyzer examination. The study showed a false-negative rate of less than 1%, according to the agency.
With only 4.2% of study participants being confirmed positive, the expected negative test value reached 99.6%, meaning negative results are likely to be very negative even for those with low prevalence or community spread of COVID-19. . The FDA said the test produced similar results in a follow-up study looking at the omicron variant of the virus.
inspection previously developed its system as a potential roadside device for recent opioid or cannabis screening. The company expects to be able to produce around 100 COVID-19 breathalyzers per week, each capable of evaluating around 160 samples per day.
Due to the burgeoning area of using exhaled breath for diagnosis, other companies are testing for COVID-19, including Breathonix, a start-up founded by the National University of Singapore that has received approval to allow temporary traffic in the country.
Other companies, like former Fierce 15 winner Owlstone Medical, are developing breath biopsy tests for cancer and diseases affecting the lungs, liver, and digestive system. Owlstone raised $58 million last year after rolling out its first commercial screening panel to differentiate between various inflammatory airway diseases, including asthma, idiopathic pulmonary fibrosis, and chronic obstructive pulmonary disease.