Virus World

The US Food and Drug Administration has granted emergency use authorization to the first Covid-19 test that spots chemical compounds associated with the coronavirus in breath, the agency said Thursday.  The FDA said the InspectIR Covid-19 Breathalyzer, which is about the size of a piece of carry-on luggage, can be used in medical offices and mobile testing sites. It can give results in less than three minutes. The system separates and identifies chemical mixtures to detect five compounds associated with SARS-CoV-2 infection. A study of the InspectIR Breathalyzer found that it accurately identified more than 91% of positive samples and nearly 100% of negative samples. Similar sensitivity was found in another study that focused on the Omicron coronavirus variant. However, a positive result should be confirmed with a PCR test, the FDA said. "It's another tool, and the FDA announcement suggests it's reasonably accurate and a relatively user-friendly tool," Dr. Emily Volk, president of the College of American Pathologists, a board-certified anatomic and clinical pathologist, said Friday. "It waits to be seen how widely this will be adopted," Volk said. "That could rely on how expensive it is." In an email to CNN on Friday, InspectIR Systems said it is not releasing the price of the machine or when it will be available. The agency's authorization "is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19," Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "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."

FDA Press Release (April 14, 2022):

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-diagnostic-test-using-breath-samples 

FDA Letter of Authorization (April 14, 2022):

https://www.fda.gov/media/157720/download?utm_medium=email&utm_source=govdelivery 

Initial findings from a new study led by Loughborough University—published by The Lancet—has shown how COVID-19 can be detected via a non-invasive breath test, providing almost instant results. Working with partners at the IMSPEX Group—Ion Mobility Spectrometry (IMS) specialists with offices in Wales and Germany—as well as the Royal Infirmary of Edinburgh and Germany's Klinikum Dortmund Hospital, the consortium's research team has been able to identify candidate biomarkers present in the breath of someone affected by COVID-19.  Utilizing technologies developed by G.A.S. GmbH as part of the pioneering TOXI-Triage project, the team has demonstrated how these markers or "breath signatures" can be used to rapidly distinguish COVID-19 from other respiratory conditions at point of need, such as an emergency department, a workplace or a care setting, with no laboratory support.

IMSPEX will be working alongside researchers to help develop and scale such technology. Its BreathSpec device has been a key tool used by researchers in the analysis of volatile organic compounds (VOCs) in human breath. Ninety-eight patients were recruited for the feasibility study, of whom 31 had COVID-19. Other diagnoses included asthma, exacerbation of asthma and COPD, viral pneumonia, other respiratory tract infections, and cardiac conditions. To identify and diagnose COVID-19 from the samples the team used Gas Chromatography (GC) – a procedure used for separating and analyzing compounds that can be vaporized without decomposition—and Ion Mobility Spectrometry (IMS) – an analytical technique used to separate and identify ionized molecules in the gas phase. Participants gave a single breath-sample forvolatile organic compounds analysis by GC-IMS. This analysis identified aldehydes (ethanal, octanal), ketones (acetone, butanone), and methanol that discriminated COVID-19 from other conditions.

Speaking about the feasibility study Paul Thomas, Professor of Analytical Science from Loughborough'sDepartment of Chemistry, said: "We are hugely encouraged by these findings. Employing tried and tested techniques used during the TOXI-Triage project, suggests that COVID-19 may be rapidly distinguished from other respiratory conditions. To develop this technique further larger studies are required, together with complementary GC-MS studies, to build on the data collected so far. If shown to be reliable, it offers the possibility for rapid identification or exclusion of COVID-19 in emergency departments or primary care that will protect healthcare staff, improve the management of patients and reduce the spread of COVID-19."

Study published in EClinicalMedicine (Oct. 24, 2020):

https://doi.org/10.1016/j.eclinm.2020.100609