Friday, March 20, 2020
AUGUSTA, Ga. (WRDW/WAGT) -- The Georgia Esoteric and Molecular Laboratory at the Medical College of Georgia Department of Pathology has developed a novel, accurate coronavirus test that can tell patients if they are infected within about two hours instead of waiting typically days to hear from remote testing facilities.
According to a news release, the Director of the GEM lab completed the COVID-19 assay validation on Sunday and immediately submitted the documentation to the FDA for their approval.
Food and Drug Administration approval is pending for the new test, the FDA released new guidance this week that its approval is no longer required for COVID-19 testing in a CLIA-certified laboratory like the GEM Lab. CLIA is a Centers for Medicare and Medicaid Services certification.
At the moment, the test is for patients whose samples are taken at the AU Health System.
The GEM Lab team is now working around the clock to increase their testing capacity, which started at 72 tests in a 24-hour period and which they want to expand to 500 in coming weeks. The MCG GEM Lab also will work with other CLIA-certified labs interested in offering their new test.
Their new test is based on modified testing recommendations from the Centers for Disease Control and Prevention and focuses on two unique genetic markers for the virulent virus.
Until now, a patient sample from the Augusta area would be taken, put on a plane to a reference lab, where it may take three to four hours to process.
For the first real-time test run this past weekend, the GEM Lab team began analyzing the sample at 10 p.m. and was reporting the status shortly after 2 a.m. to physicians at AU Health System. These first tests ultimately confirmed the first cases of infection reported in the Augusta area.
While the coronavirus test is in serious short supply because of rapidly escalating and unexpected demand, the individual components needed to make a test are not yet as in demand, so the GEM Lab team’s work included finding needed parts like the extraction cassettes they put the patient sample in.
“The GEM Lab team has worked 24/7 to complete validation and implementation in absolutely record time,” says Dr. Amyn Rojiani, chair of the MCG Department of Pathology. “Kudos to the entire team for their uncompromising dedication and expertise that has now made this test directly available for the first time to the Augusta community,”
Symptoms of COVID-19 infection may occur two to 14 days after exposure and include fever, cough, difficulty breathing and shortness of breath.
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