FDA authorizes 1st breath test for COVID-19
The emergency authorization was issued for what it called the first device to detect COVID-19 in breath samples.
The Food and Drug Administration issued an emergency use permit for what it asserts is the first gadget capable of detecting COVID-19 in breath samples on Thursday.
According to the FDA, the InspectIR COVID-19 Breathalyzer is roughly the size of a piece of carry-on baggage and may be utilized in doctor's offices, hospitals, and mobile testing locations. The test, which may yield findings in under three minutes, must be performed under the supervision of registered health care professionals.
The gadget was described as "yet another example of the rapid innovation occurring with diagnostic tests for COVID-19" by Dr. Jeff Shuren, head of the FDA's Center for Devices and Radiological Health.
The gadget was 91.2% effective in detecting positive test samples and 99.3% accurate in identifying negative test samples, according to the FDA.
The FDA stated that InspectIR said it could produce nearly "100 instruments per week, which can each be used to evaluate approximately 160 samples per day," adding that testing capacity could be expected to spike up by "64,000 samples per month."