For the first time, Americans can be tested for COVID-19 simply by breathing into a device. The U.S. Food and Drug Administration has granted emergency use authorization to a breath-based COVID-19 test made by a company called InspectIR — a milestone that opens a new chapter in how infectious disease is diagnosed.
At a glance
- COVID-19 breath test: The InspectIR device returns results in about three minutes, using gas chromatography mass-spectrometry to analyze patterns of volatile organic compounds in exhaled breath.
- Test sensitivity: In a study of nearly 2,500 people, the device correctly identified 91.2 percent of positive COVID-19 cases and 99.3 percent of negative ones.
- Emergency use authorization: The FDA’s approval makes this the first breath-based COVID-19 diagnostic cleared for use in the United States, with deployment expected at hospitals and mobile testing sites.
How the technology works
The InspectIR device does not search for viral particles directly. Instead, it detects a signature pattern of five volatile organic compounds that the body produces in response to SARS-CoV-2 infection. Gas chromatography mass-spectrometry — a method long used in laboratory science and environmental testing — separates and identifies those compounds with high precision.
The result is a test that requires no nasal swab and no laboratory processing. A person breathes into the device, and within three minutes a trained operator receives a positive or negative reading.
Jeff Shuren of the FDA’s Center for Devices and Radiological Health called the authorization “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” adding that the FDA aims to advance technologies that can help the U.S. respond to future public health emergencies as well.
What makes this meaningful
Breath-based diagnostics have long been a goal in medicine. The appeal is straightforward: breathing is non-invasive, universally accessible, and produces a rich chemical signal that reflects what is happening inside the body. Getting regulatory approval for a breath test for any infectious disease is genuinely hard, and this authorization is the first of its kind for COVID-19 in the U.S.
The accuracy figures are strong. A specificity of 99.3 percent means very few healthy people would receive a false positive — an important factor when a positive result can trigger isolation, anxiety, and follow-up testing. The 91.2 percent sensitivity is competitive with many rapid antigen tests already in wide use.
Beyond COVID-19, the authorization signals growing regulatory confidence in VOC-based diagnostics as a category. Researchers have been exploring breath analysis for cancer, kidney disease, and other conditions for years. A cleared COVID-19 breath test gives the field a meaningful proof of concept.
Early limits and what comes next
The current device has real constraints. It must be operated by trained personnel under healthcare provider supervision, and the equipment — though engineered into a luggage-style case — is far from pocket-sized. InspectIR’s initial production capacity is roughly 100 units per week, each capable of processing around 160 samples per day. That limits deployment to select hospitals and testing sites in the near term.
Researchers elsewhere are working on smaller, cheaper alternatives. A team in Singapore has demonstrated a portable breath test using Raman spectroscopy — a sensor technology that can be built into compact devices — that also detects VOC patterns linked to COVID-19 infection. In Australia, a separate group is conducting clinical trials on a device designed to detect actual SARS-CoV-2 particles in breath samples. Both efforts point toward a future where breath-based testing is fast, accessible, and deployable outside clinical settings.
The FDA’s emergency use framework has now authorized hundreds of COVID-19 diagnostic tools since 2020 C.E., ranging from PCR lab tests to at-home rapid antigen kits. Adding a breath test to that portfolio reflects how far diagnostic science has moved in a short time.
Breath diagnostics also carry potential equity benefits worth noting. Communities with lower rates of healthcare access — including many rural, Indigenous, and lower-income populations — have faced disproportionate barriers to timely COVID-19 testing. Non-invasive, rapid tools that can be deployed at mobile sites have the potential to reach people that fixed laboratory infrastructure does not. Whether that potential is realized will depend on pricing, production, and distribution decisions that have not yet been made.
For now, the InspectIR authorization is a concrete first step. It proves that breath-based COVID-19 testing can meet a regulatory bar, and it puts pressure on the broader field to build on that foundation with tools that are smaller, faster, and more widely available.
Read more
For more on this story, see: New Atlas
For more from Good News for Humankind, see:
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- The Good News for Humankind archive on global health
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