ReachMD

A new diagnostic test that uses breath samples to detect COVID-19, known as the InspectIR COVID-19 Breathalyzer, has been developed by scientists in China. This major breakthrough could allow for early detection of the COVID-19 virus and help to prevent outbreaks from spreading. The test is said to be accurate 95 percent of the time, a number is that significantly higher than other tests currently available.

This test can be performed in settings such as doctor’s offices, hospitals, and mobile testing sites using a tool that’s roughly the same size as a piece of carry-on luggage. This device uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly detect five Volatile Organic Compounds (VOCs) associated with COVID-19.

Director of the FDA’s Center for Devices and Radiological Health Dr. Jeff Shuren explains how novel these tests are for not only the COVID-19 pandemic, but for the healthcare field overall.

“[This] authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Dr. Shuren. “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.”

In a study with 2,409 participants, the InspectIR COVID-19 Breathalyzer was shown to have 91.2 percent sensitivity in patient with positives samples of the test, and 99.3 percent sensitivity in patients with negative samples of the tests. The study also showed that the test had a negative predictive value of 99.6 percent in a population with only 4.2 percent of individuals who are positive for the virus, which means that patients who receive a negative test result as likely to be truly negatives in areas of low disease prevalence.

It's important to note that negative results with the InspectIR COVID-19 Breathalyzer should be considered within the context of each individual patient, and clinicians should also take into consideration that patient’s recent exposures, history, and the presences of clinical signs and symptoms that could be consistent with a COVID-19 infection.

Currently, the InspectIR COVID-19 Breathalyzer is expecting to produce about 100 instruments per week, and at that production level, clinicians and healthcare professionals would be able to evaluate approximately 160 samples per day and is expected to increase to approximately 64,000 samples per month.

While the InspectIR COVID-19 Breathalyzer is still in the early stages of development, it continues to show promise and could be a game-changer in the combat against COVID-19.