FDA Authorizes First COVID-19 Test Using Breath Samples

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The U.S. Food and Drug Administration, on Thursday,  issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test equipment made by a Frisco startup by  InspectIR COVID-19 Breathalyzer that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. 

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19. 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 U.S. for the next public health emergency.” 

Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health

An extensive study of 2,409 people, including those with and without symptoms, was used to validate the performance of the InspectIR COVID-19 Breathalyzer. The test was shown to have 91.2 percent sensitivity (the percentage of positive samples accurately recognised by the test) and 99.3 percent specificity in the study (the percent of negative samples the test correctly identified). 

When the SARS-CoV-2 VOC markers are detected by the InspectIR COVID-19 Breathalyzer, a presumptive (unconfirmed) positive test result is returned, which should be confirmed with a molecular test.

Negative results should be interpreted in light of a patient’s recent exposures, medical 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.

  • The test can be carried out in places where the patient’s samples are both collected and analyzed, such as doctor’s offices, hospitals, and mobile testing sites, with a device roughly the size of a carry-on suitcase.
  • The test is administered by a qualified, trained operator under the supervision of a health care physician who is licenced or permitted by state law to prescribe tests, and it takes less than three minutes to get results.

When the SARS-CoV-2 VOC markers are detected by the InspectIR COVID-19 Breathalyzer, a presumptive (unconfirmed) positive test result is returned, which should be confirmed with a molecular test.

Negative results should be interpreted in conjunction with a patient’s recent exposures, medical 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.

InspectIR aims to be able to create around 100 instruments per week, each capable of evaluating around 160 samples per day. Testing capacity for the InspectIR COVID-19 Breathalyzer is estimated to rise by roughly 64,000 samples per month at this level of production.

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