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Source: https://www.cidrap.umn.edu/news-perspective/2022/04/fda-authorizes-covid-breath-test-emergency-use
FDA authorizes COVID breath test for emergency use
Filed Under:
COVID-19
Lisa Schnirring | News Editor | CIDRAP News
| Apr 15, 2022
The US Food and Drug Administration (FDA) yesterday authorized for emergency use the first COVID-19 test based on breath samples, a system that looks for chemical signatures of infection and can provide a result in about 3 minutes.
The development comes as US COVID-19 cases are rising slightly in some areas, especially in the Northeast, amid Easter and spring break travel and as the proportion of more transmissible BA.2 subvariant infections rises. The 7-day daily averages today are at 36,503 cases and 522 deaths, according to a Washington Post analysis.
Quick testing method sidesteps biological materials
In its announcement yesterday, the FDA said the device, from Texas-based InspectIR, is about the size of a piece of carry-on luggage and is designed for use in settings such as doctor's offices, hospitals, and testing sites. Testing is done by qualified, trained operators under the supervision of licensed healthcare providers.
The breathalyzer uses gas chromatography mass spectrometry to identify chemical mixtures and identify compounds linked to SARS-CoV-2 infection in exhaled breath. A positive test is considered a presumptive positive, with results intended to be confirmed with polymerase chaine reaction (PCR) testing. The FDA said a negative test doesn't rule out infection and shouldn't be used as the sole basis of clinical management.
The FDA said a large study found 91.2% sensitivity and 99.3% specificity for the test. A follow-up study that focused the Omicron variant found similar sensitivity results.
Jeff Shuren, MD, JD, who directs the FDA's Center for Devices and Radiological Health, said the authorization is another example of rapid innovation in diagnostic testing 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."
The company said it expects to make about 100 units a week, and each can evaluate about 160 samples a day.
In an InspectIR video, the person undergoing screening inserts a single-use sanitary straw and provides a quarter liter of exhaled air, about the amount it takes to inflate a small balloon. Providing a viable sample takes about 10 seconds.
InspectIR said no biological materials are stored in the device, and there is no risk of cross-reactivity. The chemicals in the captured breaths are rapidly heated and ionized, which the company says leaves the device clean and calibrated for the next test.
China grapples with impact on companies
In China's surge, cases remain high in Shanghai, the country's main hot spot. The city, home to a population of 26 million and a major international financial hub, is in its third week of lockdown, as cases—the strong majority of them asymptomatic—soar.
Chinese officials today said they will help key industries resume operations in Shanghai, amid growing concerns about economic and supply chain disruptions cause by the country's strict "zero COVID" policy, according to Reuters.
The country's National Health Commission today reported 24,166 local cases, of which 20,694 were asymptomatic. Shanghai had 92% of the symptomatic infections and 96% of the asymptomatic cases.
In other developments in hard-hit Asian nations, South Korea said as its cases continue to decline, it will drop most of its measures, except for the mask mandate, next week, according to Yonhap News.
FDA authorizes COVID breath test for emergency use
Filed Under:
COVID-19
Lisa Schnirring | News Editor | CIDRAP News
| Apr 15, 2022
The US Food and Drug Administration (FDA) yesterday authorized for emergency use the first COVID-19 test based on breath samples, a system that looks for chemical signatures of infection and can provide a result in about 3 minutes.
The development comes as US COVID-19 cases are rising slightly in some areas, especially in the Northeast, amid Easter and spring break travel and as the proportion of more transmissible BA.2 subvariant infections rises. The 7-day daily averages today are at 36,503 cases and 522 deaths, according to a Washington Post analysis.
Quick testing method sidesteps biological materials
In its announcement yesterday, the FDA said the device, from Texas-based InspectIR, is about the size of a piece of carry-on luggage and is designed for use in settings such as doctor's offices, hospitals, and testing sites. Testing is done by qualified, trained operators under the supervision of licensed healthcare providers.
The breathalyzer uses gas chromatography mass spectrometry to identify chemical mixtures and identify compounds linked to SARS-CoV-2 infection in exhaled breath. A positive test is considered a presumptive positive, with results intended to be confirmed with polymerase chaine reaction (PCR) testing. The FDA said a negative test doesn't rule out infection and shouldn't be used as the sole basis of clinical management.
The FDA said a large study found 91.2% sensitivity and 99.3% specificity for the test. A follow-up study that focused the Omicron variant found similar sensitivity results.
Jeff Shuren, MD, JD, who directs the FDA's Center for Devices and Radiological Health, said the authorization is another example of rapid innovation in diagnostic testing 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."
The company said it expects to make about 100 units a week, and each can evaluate about 160 samples a day.
In an InspectIR video, the person undergoing screening inserts a single-use sanitary straw and provides a quarter liter of exhaled air, about the amount it takes to inflate a small balloon. Providing a viable sample takes about 10 seconds.
InspectIR said no biological materials are stored in the device, and there is no risk of cross-reactivity. The chemicals in the captured breaths are rapidly heated and ionized, which the company says leaves the device clean and calibrated for the next test.
China grapples with impact on companies
In China's surge, cases remain high in Shanghai, the country's main hot spot. The city, home to a population of 26 million and a major international financial hub, is in its third week of lockdown, as cases—the strong majority of them asymptomatic—soar.
Chinese officials today said they will help key industries resume operations in Shanghai, amid growing concerns about economic and supply chain disruptions cause by the country's strict "zero COVID" policy, according to Reuters.
The country's National Health Commission today reported 24,166 local cases, of which 20,694 were asymptomatic. Shanghai had 92% of the symptomatic infections and 96% of the asymptomatic cases.
In other developments in hard-hit Asian nations, South Korea said as its cases continue to decline, it will drop most of its measures, except for the mask mandate, next week, according to Yonhap News.