The US Food and Drug Administration has granted emergency use authorization to the first Covid-19 test that can detect infections with only a sample of a patient's breath, within three minutes and with a high degree of accuracy.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for Covid-19,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement on Thursday.
The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using the InspectIR Covid-19 Breathalyzer, an “instrument about the size of a piece of carry-on luggage”.
A single machine can analyze about 160 samples per day.
Yvonne Maldonado, an infectious disease specialist at Stanford University School of Medicine who is working on another Breathalyzer test, told The New York Times that having more options to test will only help the transition to the endemic phase of the pandemic.
The performance of the InspectIR Covid-19 Breathalyzer was validated in a large study of 2,409 individuals, including those with and without symptoms.
In the study, the test was shown to have 91.2% sensitivity (the percent of positive samples the test correctly identified) and 99.3% specificity (the percent of negative samples the test correctly identified).
The test performed with similar sensitivity in a follow-up clinical study focused on the Omicron variant.
The InspectIR Covid-19 Breathalyzer uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly detect five Volatile Organic Compounds (VOCs) associated with Sars-CoV-2 infection in exhaled breath.
The FDA cautioned that “negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with Covid-19, as they do not rule out Sars-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions”.
InspectIR, the company that produces the breathalyzer, expects to be able to produce about 100 machines per week.
