Four COVID-19 Tests from Quest Diagnostics Get FDA’s Emergency Use Authorization

San Juan Capistrano, Calif.-based Quest Diagnostics’ Nichols Institute has received Emergency Use Authorizations from the FDA for four polymerase chain-reaction (PCR) tests for COVID-19.

All four tests are direct-to-consumer (DTC) products intended for the detection of nucleic acids from the SARS-CoV-2 virus in anterior nasal swab specimens.

The newly authorized diagnostic tests, which can handle multiple pooled samples, include the: Quest COVID-19 PCR test home collection kit; Quest RC COVID-19 PCR DTC test; Quest PF COVID-19 PCR DTC test; and Quest COVID-19 PCR DTC test.

Analysis of the tests is limited to laboratories designated by Quest Diagnostics that are certified under the Clinical Laboratory Improvement Amendments of 1988 and meet the requirements to perform high-complexity tests.