First non-invasive COVID-19 breath test approved by the FDA, much faster than antigen testing
The FDA has given emergency use authorization for the first COVID-19 detection test performed by a non-invasive method. InspectIR's COVID-19 Breathalyzer device doesn't require swabbing of throats or nostrils, but rather uses a combination of gas-chromatography and mass spectrometry to detect chemical compounds whose presence has been associated with an active infection.
The COVID-19 Breathalyzer's detection accuracy was tested with 2,409 individuals, some of which were asymptomatic, against the gold standard PCR testing method. The COVID-19 breath test proved to be more than 99% accurate when displaying negative results, but 91% correct for the positive ones, necessitating a PCR follow-up to confirm a positive test. Such a study was subsequently carried out specifically to determine the breath test's sensitivity towards the currently prevalent Omicron variant, and the results were very similar.
The FDA, however, issued the usual disclaimer about the exclusive reliance on the breath test for treatment:
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. When the InspectIR COVID-19 Breathalyzer detects the presence of VOC markers of SARS-CoV-2, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test. 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's COVID-19 Breathalyzer is not intended for at-home use, as it requires a mobile lab the size of a small suitcase that is more suitable for a doctor's office or a testing venue. According to the FDA, the device can analyze 160 breath samples for COVID-19 per day, as the results take only 3 minutes to process, compared to 10-15 for the widespread rapid antigen tests. At present, InspectIR can scale its production to 100 Breathalyzer devices per day, informs the FDA, which will mean a monthly increase of non-invasive COVID-19 testing capabilities by 64,000 samples.