A COVID-19 diagnostic test that uses breath samples to generate a positive or negative result has received emergency use authorization from the US Food and Drug Administration (FDA).
Dubbed ‘InspectIR’, this breath analyzer COVID-19 test detects chemical components linked to coronavirus in breath samples.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren. He is the head of the FDA’s Center for Devices and Radiological Health.
He also went on to say, “The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the US for the next public health emergency”
Evaluation and validation
The test is the size of carry-on luggage. It can show the outcome in less than three minutes, according to a report by Xinhua news agency.
The FDA also explained how one can use the test. According to them, the test must administer under the supervision of a licensed health care practitioner. It can happen at sites where patient samples are collected and analyzed at doctor’s offices, hospitals, and mobile testing sites.
The performance of the COVID-19 breathalyzer underwent evaluation and validation in a large sample of 2,409 persons. Participants in the study were both symptomatic and asymptomatic. FDA website states the trial test showed a sensitivity of 91.2 % (the percentage of positive samples correctly identified). It also had a specificity of 99.3 percent (the percentage of negative samples correctly recognized).
As per the agency, “InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day.”
“At this level of production, testing capacity using the InspectIR COVID-19 breathalyzer is expected to increase by approximately 64,000 samples per month.”
