NEW YORK – An assay from DiaSorin Molecular to detect SARS-CoV-2, the virus that causes COVID-19, has been granted Emergency Use Authorization by the US Food and Drug Administration, the company said on Friday.
The test, called the Simplexa COVID-19 Direct assay, runs on DiaSorin's sample-to-answer Liason MDX real-time PCR instrument. It is intended to qualitatively detect nucleic acid from SARS-CoV-2 in nasopharyngeal swabs from individuals suspected of COVID-19 by their healthcare provider.