A respirator analyzer that can correctly detect about nine out of 10 positive Covid-19 cases won an emergency use permit from the Food and Drug Administration on Thursday.
The diagnostic tool, called InspectIR COVID-19 Breathalyzer, was tested on 2,409 people with and without symptoms of the infection. It correctly identified 91.2% of the positive samples and 99.3%, or almost 100%, of the negative ones. A follow-up clinical study focused on the Omicron variant had similar results, according to the FDA.
InspectIR’s breathalyzer is the size of a hand luggage and can give results in less than three minutes. The tests, which are non-invasive, must be performed by a qualified, trained operator. InspectIR Systems, which is not publicly listed, said in one explanatory video that no biological materials are stored in its unit.
InspectIR distinguishes and identifies chemical compounds associated with Covid-19 exhaled infections. The company expects to be able to produce approximately 100 instruments per week; each unit can be used to evaluate about 160 samples a day, FDA executive order said.
InspectIR provides unconfirmed positive test results, so people who receive them should follow up with a molecular test, the FDA said. Negative results do not rule out infection and should be considered in light of the person’s recent exposure, history and symptoms, it states.
“The FDA continues to support the development of new COVID-19 tests aimed at advancing technologies that can help address the current pandemic and better position the United States for the next public health emergency,” said Jeff Shuren, director of FDA’s Center for Apparatus and Radiological Health.
Recently approved federal health authorities another booster dose for adults aged 50 and over. From Wednesday, the seven-day moving average of the number of new cases was about 31,000 against 420,626 at the beginning of the year.
Write to Karishma Vanjani at [email protected]