FDA Authorizes First COVID-19 Breath Test

COVID Breath Test
Source: InspectIR Systems

The InspectIR Covid-19 Breathalyzer is the first FDA authorized breath test and gives results within 3 minutes.

Recent developments in COVID-19 testing mean uncomfortable nasal swab tests might soon become a thing of the past. Over the years, scientists have come up with several different diagnostic tests, ranging from the spit test to a laser-based test. But that’s not all. Several researchers are now designing breath tests for the viral infection. One such COVID-19 breath test has now become to first to receive an FDA authorization.

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.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health

In a recent press release, the FDA granted an emergency use authorization to the InspectIR COVID-19 Breathalyzer test. The authorization is based on the results of a large study that assessed the test’s performance among more than 2,400 individuals. Both individuals with and without symptoms formed a part of the research. According to the results, the breath test correctly identified 91.2% of the positive samples (sensitivity) and 99.3% of the negative samples (specificity). Moreover, it had a negative predictive value of 99.6% among individuals who tested positive for the virus. The breath test had a similar sensitivity when checked against omicron variant infections.

Although PCR tests generally have a higher accuracy rate, nearly 100%, they are expensive and require a clinical setting.

According to InspectIR Systems’ co-founder John Redmond, the device will likely hit the market in 10 to 12 weeks. The company plans to produce approximately 100 devices per week; it will help evaluate up to 160 samples per day. Thus, significantly boosting COVID-19 screening.

‘A Chemistry Lab in a Box’

The first step involves the collection of samples. Using a single-use straw, individuals can exhale through their mouth and into a chemical analyzer part of the test kit. The test only requires enough breath to fill up a small balloon. An exhalation time of 10 seconds is generally enough to collect a viable sample. Next, the InspectIR COVID-19 Breathalyzer test conducts gas chromatography gas mass-spectrometry (GC-MS). This helps separate and identify five Volatile Organic Compounds (VOCs) that form the ‘breath print’ of a COVID infection. It is unclear what the compounds are.

The last step involves analysis of the results and within three minutes the person is given their result. In comparison, the standard PCR tests can take 2-3 days while rapid antigen tests generally give results in 15 to 30 minutes. However, the company believes a positive test requires molecular confirmation via a PCR or antigen test.

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.

InspectIR Systems

Unlike the nasal samples, that not everyone is able to provide, the test relies on a more non-invasive and painless approach. Therefore, making it an extremely valuable alternative for COVID testing. However, the device has multiple limitations.

Firstly, the device is quite large, almost the size of a carry-on suitcase, and requires trained operators. Moreover, one device can only process about 20 samples an hour which means multiple devices will be required in one location. Since certain foods and substances can affect a breath test’s results, the company instructs one to not eat, drink or use any tobacco products 15 minutes prior to the test.

Several COVID-19 Breath Tests in the Works

InspectIR believes their test will work better as a screening method where it can replace the daily temperate screens in places such as offices and restaurants. While they are the first to receive an FDA authorization, they are not the only ones working on a COVID-19 breath test.

Over the course of the pandemic, researchers have designed multiple tests with similar designs. In March of last year, Dutch inventor Peter Van Wees developed the Quick Breath Analyzer (QuBA). The device relied on people screaming or singing within a sterile, air-locked cabin. An industrial air purifier then collected and analyzed the emitted particles for the virus. Although the device is in the testing stages, it provides a safe, fast, and reliable method to test for COVID-19. Moreover, researchers believe that it can serve as a potential screening tool in airports and schools.

In December of last year, a team at Brown University and Rhode Island Hospital developed Bubbler. The RNA-based breath test works by detecting airborne viral fragments within breath samples. It consists of a glass tube and a mouthpiece. Within the tube, a reverse transcription reaction mixture and cold mineral oil help reverse transcribe airborne viral RNA particles to DNA. Thus, helping to identify the viral load of the sample. Moreover, a study investigating the test’s effectiveness found it more effective at detecting lower respiratory test infections. Professor William G. Fairbrother, the study’s lead investigator, stated the technology can also work as a possible early-warning system.

Source: US Food and Drug Administration


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