New COVID-19 breath test reports over 90% accuracy
The US Food and Drug Administration (FDA) has granted an emergency use approval for a breath-based COVID-19 diagnostics test. The test device has successfully identified 91.2% of positive cases in a cohort of 2,500 subjects, according to a metric known as test sensitivity. The specificity of the test was even higher, as it correctly identified 99.3% of negative cases in that same cohort.
The test device was developed by a company called InspectIR and uses gas chromatography mass-spectrometry (GC-MS) to analyse breath samples. Unlike previous prototypes which scan for the presence of specific viral particles, the new device looks for a pattern of five specific volatile organic compounds (VOCs) that correspond with a SARS-CoV-2 infection.
[SARS-CoV-2 is the virus behind Coronavirus Disease 2019 (COVID-19). The discovery of VOCs based on breath analysis offers a reliable, rapid, and affordable screening method for the virus’ aggressive infection.]
The FDA’s authorisation of InspectIR’s breathalyser marks the first approval for a breath-based COVID-19 testing technology in the US. Although each unit of the breathalyser is said to be able to process around 160 samples a day, the slightly-large device, however, can only be used by trained operators under the supervision of health care providers.
Jeff Shuren, from the FDA’s Center for Devices and Radiological Health, commented: “Today’s authorisation 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 US for the next public health emergency.”
There are several other COVID-19 breath-testing systems in the works, as researchers hope to make this kind of technology more accessible. In February, a team of researchers in Singapore demonstrated a small portable COVID-19 breathalyser that delivers highly accurate results in minutes. This device relies on Raman spectroscopy to detect unique patterns of VOCs in breath.
Meanwhile, a team of researchers in Australia are working on a prototype device designed to detect SARS-CoV-2 particles from breath samples. Clinical trials are currently underway to validate its accuracy and if successful it could be available as early as 2022.
Category: Features, Technology & Devices
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