The US Food and Drug Administration (FDA) has approved for the first time a COVID-19 test that is done by blowing. The so-called InspectIR COVID-19 Breathalyzer detects the existing chemical components in the breath samples that are taken and that are associated with this disease, the FDA explained in a statement.
The test is done by blowing into a tube that is connected to a balloon-shaped device that captures the sample. The FDA has explained that this type of test can be carried out in places such as clinics, hospitals and mobile COVID testing sites, under the supervision of specialized personnel, and it takes three minutes to produce a result.
An FDA official, Jeff Shuren, has said in the note that the authorization "is another example of rapid innovation on COVID-19 tests." The new test uses a technique called Gas Chromatography coupled to Mass Spectrometry (GC/MS), which is used to separate and identify combined chemical substances and quickly detects five volatile organic compounds linked to infection by COVID.
When the test finds the presence of markers for these organic compounds, it gives a positive result, which, according to the FDA, should be confirmed later with a molecular test. The test was the subject of a study with 2,409 volunteers, with and without symptoms of COVID-19, and in which it was shown that the test had a sensitivity of 91.2%, a percentage that refers to the positives that InspectIR COVID-19 19 Breathalyzer correctly identified.
Additionally, the test had 99.3% specificity, which is the rate of negatives that the test correctly detected. The analysis also showed that in a population with only 4.2% of infected individuals, the test had a predictive value of 99.6%, which means that it is reliable in areas with a low incidence of the disease. The manufacturer hopes to be able to produce 64,000 tests per month.