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FDA Grants Emergency Use Authorizations for Quest Coronavirus Assays

NEW YORK — The US Food and Drug Administration on Wednesday issued Emergency Use Authorizations for three SARS-CoV-2 tests from Quest Diagnostics that use nasal swab self-collection devices.

Quest's PF SARS-CoV-2 Assay is performed using Hologic's Panther Fusion SARS-CoV-2 RT-PCR-based test, its RC SARS-CoV-2 Assay is performed using Roche's automated Cobas SARS-CoV-2 RT-PCR test, and its HA SARS-CoV-2 Assay is performed using Hologic's Aptima SARS-CoV-2 test.

All three tests are RT-PCR-based and have previously received EUA from the FDA.

According to the FDA, the three Quest assays use nasal swab samples collected using the company's Self-Collection Kit for COVID-19 or other authorized home-collection kit while observed by a healthcare provider via telemedicine.

Collected samples are shipped to Quest-designated laboratories CLIA-certified to perform high-complexity tests, the FDA said.