FDA approves first breath test for COVID-19 in the U.S.
The U.S. Food and Drug Administration (FDA) has given an emergency use authorization to the first breath test for detection of COVID-19, the regulatory authority said in a press release.
With the threat of the COVID-19 pandemic still looming large, there is a need for detection methods that can be used to rapidly detect individuals. PCR-based tests are highly accurate but have a major drawback of high waiting times for results. On the other hand, antigen tests can give results instantly but have a high dependence on the supply chain for components. A breath test brings together the best of both worlds without their drawbacks.
How does it work?
The detection device called InspectIR is the size of a piece of carry-on luggage and uses disposal paper straws as a consumable to carry out the test. It requires the individual being tested to blow on the paper straw, which is then inserted into the sample analysis tray to determine if the test is positive or not. Singapore approved a similar device 10 months ago.
The technique used in this case is called gas chromatography-mass spectrometry (GC-MS) where the air sample on the paper straw is vaporized and its contents bombarded with a high-energy beam of electrons. The sample breaks into smaller molecules that are analyzed by their mass to charge ratio.
In the case of this detection, InspectIR is only on the lookout for five compounds that have been associated with COVID-19 infection and will return a test as positive in a matter of three minutes, if they are found.
Where will you likely see the instrument?
Given its rapid rate of detection, the instrument is meant to perform mass testing. This isn't the type of testing where a large number of detection kits are distributed by mail and testing performed in the comfort of your home.
Instead, a health care practitioner will need to take a sample, even though, it isn't as invasive as a nasal swab. The instrument is likely to be placed at healthcare establishments such as nursing homes or in the hospitality industry which sees a high number of people every day. You are more likely to provide a sample for such testing before getting on an airplane in the future.
In a study conducted on over 2,400 people, the device was able to accurately detect 91.2 percent of the cases. However, in spite of its FDA authorization, a positive test is only "presumptive" and needs to be confirmed with a PCR test, ABC News reported.
The company which designed the device is looking to manufacture about 100 such devices per week and lease them out to sectors that are interested in mass testing.
Probably, the next time you take a COVID-19 test, all you need to do is relax and exhale.
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