FDA announced this week that it’s granted an emergency use authorization for Mayo Clinic’s real-time polymerase chain reaction test for SARS-CoV-2, the virus that causes COVID-19.
The Rochester, Minn.–based health provider is already running thousands of coronavirus tests daily — with help from diagnostic processors from Roche Diagnostics, that run the Roche Cobas SARS-CoV-2 test. State officials in Minnesota see Mayo Clinic’s testing efforts playing an important role in North Star State’s economic reopening.
Mayo Clinic’s own test, announced last month, offers an advantage because it can produce results within 24 hours, using respiratory specimens from nasopharyngeal swabs, throat swabs, nasal swabs, sputum, tracheal secretions, BAL fluid, and bronchial washings. The real-time reverse transcription polymerase chain reaction (rRT-PCR) test uses Biomérieux
EasyMAG and EMAG extraction instruments and the Roche LightCycler 480 amplification system.
The EUA, granted in an April 20 letter from FDA, provides an important indicator of the test’s accuracy.