June 30, 2022

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FDA urgently authorized the first COVID-19 breathing test platform

FDA urgently authorized the first COVID-19 breathing test platform



 

No need to be stabbed: FDA urgently authorized the first COVID-19 breathing test platform, get the results in three minutes

The U.S. Food and Drug Administration (FDA) has urgently authorized the first diagnostic test for COVID-19 based on a breath sample . No nasal swabs or throat swabs are needed, only the exhaled gas needs to be tested, and the test results can be obtained in less than three minutes .

 

FDA urgently authorized the first COVID-19 breathing test platform

 

This is the first Emergency Use Authorization (EUA) issued by the FDA to diagnose COVID-19 by detecting compounds associated with COVID-19 infection in breath samples .

The size of this device is close to an ordinary suitcase. Due to the portability of the device, it can be used in multiple scenarios such as hospitals, doctors’ offices, public places, and mobile monitoring stations.

 

People only need to blow air through a disposable straw under the guidance of a trained operator, and the device can complete the collection and detection of breath samples, and the test results can be obtained in less than 3 minutes.

 

FDA urgently authorized the first COVID-19 breathing test platform

 

 

Developed by InspectIR, the Covid-19 breath analyzer uses gas chromatography-mass spectrometry (GC-MS) to separate and identify compounds in exhaled breath and quickly detect five of these volatile organic compounds associated with Covid-19 infection. 

Once the presence of the five markers was detected, the analyzer showed a positive test result, a process that took less than three minutes.

 

FDA urgently authorized the first COVID-19 breathing test platform

 

The efficacy of the COVID-19 breath analyzer was previously confirmed in a large study of 2409 people (including symptomatic, asymptomatic, and uninfected people) , and the results showed that the analyzer had a detection sensitivity of 91.2% ( This means, out of 1000 positive patients, 912 can be detected) .

The detection specificity was 99.6% (meaning, out of 1000 negative population, only 4 false positives occurred) .

In addition, subsequent tests for Omicron have similar sensitivity and specificity.

 

The FDA also reminded that samples tested positive by the COVID-19 breath analyzer should be further confirmed by nucleic acid testing.

For negative samples, it can be judged based on the recent contact history of the tested person, the history of disease, and the presence of symptoms related to the COVID-19.

This test result should not be used as the sole basis for treatment, patient management, or disease control.

 

Dr. Jeff Shuren , director of the FDA’s Center for Devices and Radiological Health , said that this authorization is another example of rapid innovation in COVID-19 diagnostic tests. Prepare for possible public health emergencies.

 

InspectIR previously focused on developing portable breath analyzers for opioid and cannabis detection. In the wake of the Covid-19 pandemic, InspectIR began research and development of a portable breath analyzer to detect Covid-19.

 

 

 

 

 

References :
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-diagnostic-test-using-breath-samples

Developed by InspectIR, the Covid-19 breath analyzer uses gas chromatography-mass spectrometry (GC-MS) to separate and identify compounds in exhaled breath and quickly detect five of these volatile organic compounds.

(source:internet, reference only)


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