Quest Diagnostics announced it will launch a coronavirus (COVID-19) test service for patients in the United States.
Quest will begin receiving specimens and providing testing on March 9, 2020.
The new test service will be provided as a laboratory-developed test, pending review by the Food and Drug Administration (FDA) under an emergency use authorization (EUA), which the company will submit per FDA guidance within 15 days of clinical testing.
A molecular-based assay, the test detects nucleic acid in respiratory specimens of patients meeting Centers for Disease Control and Prevention’s (CDC) clinical criteria for COVID-19 testing.
Respiratory specimens for the test will be collected in appropriate healthcare settings, such as hospitals and physician offices. Quest Diagnostics patient service centers and phlebotomy sites do not collect respiratory specimens on suspected COVID-19 cases.
Coronavirus disease 2019 or COVID-19 (formally known as 2019-nCoV) is the name for the respiratory syndrome caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
