JAKARTA - The US Food and Drug Administration (FDA) has for the first time issued a permit for the emergency use of COVID-19 diagnostics through breath samples. The trick is to use the InspectIR COVID-19 Breathalyzer.
Through the device, tests can take place in environments where patient specimens are collected and analyzed, such as doctors' offices, hospitals and mobile test sites, using carry-on-sized instruments.
"The test is performed by a qualified and trained operator under the supervision of a healthcare provider licensed or authorized by state law to prescribe the test and can provide results in less than three minutes," the FDA said in a statement.
The FDA's Center for Devices and Radiological Health (CDRH) director Jeff Shuren said the clearance was another example of rapid innovation happening with diagnostic tests for COVID-19.
"The FDA continues to support the development of new COVID-19 tests with the aim of improving technology that can help cope with the current pandemic while better positioning the US for the next general public health emergency," he said.
The InspectIR COVID-19 Breathalyzer uses a technique called gas chromatography-mass spectrometry (GC-MS) to separate and identify chemical mixtures.
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