InspectIR Covid-19 Breathalyser is designed for use in doctor’s offices, hospitals and mobile testing sites using a compact instrument, and provides results within three minutes
FDA authorises InspectIR Covid-19 breathalyser. (Credit: PIRO4D from Pixabay)
The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for a Covid-19 breathalyser test developed by medtech company InspectIR.
InspectIR Covid-19 Breathalyser is said to be the first Covid-19 diagnostic test, capable of detecting compounds related to SARS-CoV-2 infection in patient’s breath samples.
It leverages gas chromatography gas mass-spectrometry (GC-MS) technique to separate and identify chemical compounds, and detect five Volatile Organic Compounds (VOCs) linked to SARS-CoV-2 infection in breath.
After detecting the presence of VOC markers related to SARS-CoV-2, the test returns an unconfirmed positive result, which is required to be confirmed with a molecular test.
For a negative result, patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with Covid-19 are considered.
InspectIR Covid-19 Breathalyser is designed for use in doctor’s offices, hospitals and mobile testing sites using a compact instrument, and provides results within three minutes.
It requires a qualified, trained operator to perform the test, under the supervision of a health care provider authorised by the local law to prescribe the tests, said the company.
FDA Centre for Devices and Radiological Health director Jeff Shuren said: “Today’s authorization 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 U.S. for the next public health emergency.”
InspectIR said that the performance of its Covid-19 breathalyser has been validated in a study of 2,409 participants, including symptomatic and symptomatic individuals.
In the study, the test has showed 91.2% sensitivity and 99.3% specificity, along with a negative predictive value of 99.6%.
The company claims that it can produce around 100 Covid-19 breathalyser devices per week, where each device can evaluate around 160 samples per day.
With the estimated production level, the testing capacity using its Covid-19 Breathalyser will increase by around 64,000 samples per month, said InspectIR.