The US Food and Drug Administration (FDA) authorized first COVID-19 diagnostic test using breath samples on Thursday. According to the agency, the test can be performed in doctor’s offices, hospitals and mobile testing sites, using an instrument, called InspectIR Covid-19 Breathalyzer, which is about the size of a piece of carry-on luggage. The results are obtained in less than a minute.
Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a statement:
“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.”
Forbes: Key Points
- The breathalyzer correctly identified positive samples 91.2% of the time in a study of 2,409 people, and it also performed well in a subsequent study assessing its effectiveness against the virus’ omicron variant, according to an FDA release.
- The breath test provides results in under three minutes, and can be administered at either healthcare facilities or mobile testing sites using an instrument roughly the size of an item of carry-on luggage, the agency said.
- InspectIR projects it will eventually be able to produce about 100 Covid-19 breathalyzers per week, each of which could perform about 160 tests per day, the FDA said.
- At InspectIR’s current levels of production, the Covid-19 breathalyzer should boost the U.S.’s testing capacity by about 64,000 samples each month, the agency said.
Source: FDA Authorizes First Covid Breath Testing Device | Forbes
- FDA authorizes first Covid-19 breath test
- FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples
- FDA Authorizes First Covid Breath Testing Device
Referring the FDA statement, CNN Health writes “A study of the InspectIR Breathalyzer found that it accurately identified more than 91% of positive samples and nearly 100% of negative samples. Similar sensitivity was found in another study that focused on the Omicron coronavirus variant. However, a positive result should be confirmed with a PCR test.”
Dr. Emily Volk, president of the College of American Pathologists, a board-certified anatomic and clinical pathologist, told CNN “It’s another tool, and the FDA announcement suggests it’s reasonably accurate and a relatively user-friendly tool. It waits to be seen how widely this will be adopted. That could rely on how expensive it is.”
Coronavirus-19 vaccination watch
According to the US Centers for Disease Control and Prevention (CDC) COVID vaccination tracker page (as of April 16, 9 p.m.) 718,039,345 doses have been distributed and 569,032,907 doses administered. According MDH COVID-19 Response vaccine data a total of 9,672,490 doses of Covid-19 (Pfizer & Moderna) vaccines have been administered in Minnesota. According to the MDH latest tally (as of April 15) the confirmed COVID-19 cases in Minnesota are 1,437,638 with 12,464 deaths.