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FDA approves COVID-19 breathalyzer test

The FDA approved a COVID-19 breathalyzer test that can provide results in three minutes

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A sign for the Food and Drug Administration.

A sign for the Food and Drug Administration is seen in Silver Spring, Md., on Thursday, Dec. 10, 2020. Last week, the FDA approved the InspectIR COVID-19 Breathalyzer that can have up to 99% accuracy in detecting negative tests in three minutes.

Manuel Balce Ceneta, Associated Press

Last week, the Food and Drug Administration approved the InspectIR COVID-19 Breathalyzer that can have up to 99% accuracy in detecting negative tests in three minutes.

How does it work?

  • To take the test, patients blow into a tube that is attached to a chemical analyzer. The machine then analyzes the breath samples and detects them for elements of COVID-19, according to The New York Times.
  • The test, which can provide results in less than three minutes, needs to be carried out under the supervision of a licensed health care provider, The Associated Press reported.

How accurate is the test? The FDA states that the device is 91.2% accurate at identifying positive COVID-19 cases and 99.3% accurate at identifying negative tests.

  • However, the FDA recommends a molecular test to confirm positive tests, and “negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.”

Limitations of the test: The FDA stated that even though the results are fast and mostly accurate, the machine could fail to detect 1 in 10 positive cases, according to The Washington Post.

  • There are also other factors that could skew the results, such as the food you eat before the test. Instructions for the test specify that patients should not eat, drink or use tobacco products within 15 minutes of taking the test, according to The New York Times.

Looking to the future: The tests aren’t expected to hit the market for anther 10 to 12 months, said the co-founders of InspectIR Systems, the company that manufactures the machines, according to The New York Times.

“The device’s pricing has not yet been finalized, but the co-founders said on Friday that they hope to be able to offer licenses or subscriptions that translate to a cost of about $10 to $12 per test,” reported The New York Times.