The Food and Drug Administration approved the first COVID breathalyzer test earlier this week.
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The test can reportedly provide faster results in under three minutes
On Thursday, the FDA announced their emergency authorization for the test, the InspectIR COVID-19 Breathalyzer for use. Metro UK reports the product is approximately the size of a carry-on suitcase and can be used in doctor’s offices, hospitals, and mobile testing sites and test results will be provided in less than three minutes. The purpose of the test is to detect chemical compounds that are interconnected with the coronavirus.
Recent data revealed that the InspectIR was able to accurately identify over 91% of positive results of covid samples and nearly 100 % after 2,409 people participated in a study with or without symptoms of the virus.
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This COVID breathalyzer test can detect the virus by analyzing chemical compounds in an individual’s breath.
“The InspectIR COVID-19 Breathalyzer uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly detect five Volatile Organic Compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath. When the InspectIR COVID-19 Breathalyzer detects the presence of VOC markers of SARS-CoV-2, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, as they do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions,” the FDA said in a statement.
The new tests can significantly improve the production of samples in a month
The company is reportedly expected to produce 100 tests per week and it can be used to analyze 160 samples per day. Testing capacity for the instrument is expected to increase by at least 64,000 samples.
At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”
Director of FDA’s Center for Devices and Radiological Health Jeff Shuren, M.D., said the new authorization is a “rapid innovation occurring” for COVID tests.
“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.”