FDA approves first COVID breath test for emergency use
FOX Business Flash top headlines for April 15
Here are your FOX Business Flash top headlines for April 15.
The Food and Drug Administration (FDA) on Thursday issued an emergency use authorization for the first COVID-19 diagnostic test that can detect SARS-CoV-2 infection in breath samples.
"Today’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."
PHILADELPHIA BUSINESSES BASH REINSTATED MASK MANDATE
The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage and tests can be performed in environments where the patient specimen is both collected and analyzed.
Results can be provided by a qualified, trained operator under the supervision of a licensed health care provider in less than three minutes.
The instrument utilizes 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 it detects the presence of infection, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test.
GET FOX BUSINESS ON THE GO BY CLICKING HERE
Negative results, the FDA noted, should be considered in the context of a patient's history, recent exposures and COVID-19 signs or symptoms, 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."
The device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.
Fauci says it’s up to each person to assess their own COVID risk
Fox Business contributor Dr. Marty Makary discusses Dr. Fauci’s switch in narrative over COVID protocols to encourage individuals to asses their own risk on ‘Fox Business Tonight.’
"The study also showed that, in a population with only 4.2% of individuals who are positive for the virus, the test had a negative predictive value of 99.6%, meaning that people who receive a negative test result are likely truly negative in areas of low disease prevalence. The test performed with similar sensitivity in a follow-up clinical study focused on the omicron variant," the agency wrote.
CLICK HERE TO READ MORE ON FOX BUSINESS
InspectIR expects to be able to produce approximately 100 instruments per week – used to evaluate around 160 samples each day.
Testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.
The Associated Press contributed to this report.
Source: Read Full Article