A 3D-printed COVID-19 breath test delivers results within 60 seconds from just one (1) or two (2) breaths, according to Washington University in St. Louis researchers. It is the same team that recently developed an air monitor that can detect the COVID-19-causing SARS-CoV-2 virus in the air within minutes. Researchers from the McKelvey School of Engineering and the School of Medicine used the same ultrasensitive biosensing technique for the breath test.
The small, portable and adaptable device could help fight the airborne virus if it can deliver faster, easier results with fewer false negatives than at-home rapid tests. Most COVID-19 transmission is still pre-symptomatic and asymptomatic. The researchers envision their device being used for rapid diagnosis by doctors or to screen people in shared spaces, such as public events, nursing halls, student housing, cruise ships or military bases. “With this test, there are no nasal swabs and no waiting 15 minutes for results, as with home tests,” said Co-Corresponding Author Rajan Chakrabarty, the Harold D. Jolley Career Development Associate Professor of Energy, Environmental and Chemical Engineering. “A person simply blows into a tube in the device, and an electrochemical biosensor detects whether the virus is there. Results are available in about a minute.”
The team says their breath test could be modified to detect influenza, respiratory syncytial virus (RSV) and other viruses — even saying they could test for novel pathogens within two (2) weeks of sampling them. The FDA granted Emergency Use Authorization (EUA) last year to the first COVID-19 breath test, the InspectIR COVID-19 Breathalyzer. But that device is larger — approximately the size of a piece of carry-on luggage — and uses gas chromatography gas mass-spectrometry.
The Washington University in St. Louis team’s device uses an antibody from llamas that recognizes a protein in the SARS-CoV-2 virus. “It’s a bit like a breathalyzer test that an impaired driver might be given,” said John Cirrito, a Professor of Neurology at the Washington University School of Medicine in St. Louis on the research team. “And, for example, if people are in line to enter a hospital, a sports arena or the White House Situation Room, 15-minute nasal swab tests aren’t practical, and PCR tests take even longer. Plus, home tests are about 60% to 70% accurate, and they produce a lot of false negatives. This device will have diagnostic accuracy.”
Testing the COVID-19 breath test
The researchers had COVID-positive individuals breathe into a straw attached to the device two (2), four (4) or eight (8) times. They reported accurate reads after two breaths, and no false negatives.
The researchers also found that the breath test successfully detected several different strains, including the original strain and the omicron variant. The team is currently measuring active strains in clinical studies. The researchers awarded Y2X Life Sciences an exclusive licensing option for the technology. Y2X Life Sciences was co-founded by Cirrito’s brother, Tom Cirrito. The research team and members of Y2X Life Sciences have been working with each other since the beginning of the project, including during device design, to facilitate possible commercialization of the test in the future,” the University said.
REFERENCE: Medical Design & Outsourcing; 01 AUG 2023; Jim Hammerand