Wednesday, March 18, 2020

Quidel Says It Has COVID-19 Test

San Diego-based Quidel, which develops rapid diagnostic testing products, says it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its real-time RT-PCR test intnded to detect COVID-19, the virus that casuees SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens. The company said the testing authorization is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The company says it has manufactured kits, which it claimed are now in transit to customers, and that it is ramping production on its PCR testing kits. The company did not say how soon it expects tests to be run through its systems, or how many tests it would be able to support.

---