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FDA Grants EUAs for Cleveland Clinic COVID-19 PCR Test, Quest Diagnostics Sample Self-Collection Kit

NEW YORK — The US Food and Drug Administration has granted separate Emergency Use Authorizations for a PCR-based SARS-CoV-2 test developed by the Cleveland Clinic and a sample collection kit for COVID-19 testing from Quest Diagnostics.

The Cleveland Clinic's SelfCheck Cobas SARS-CoV-2 Assay is designed to detect the SARS-CoV-2 ORF1ab and E genes in anterior nasal swab specimens self-collected using the SelfCheck COVID-19 Swabbing Kit.

The test runs on Roche's Cobas 6800 and 8800 RT-PCR systems and may only be performed by the Cleveland Clinic.

The Quest Diagnostics Collection Kit for COVID-19 is designed for the at-home collection of anterior nasal swab specimens, which are to be sent to Quest-designated laboratories for molecular testing.

Both institutions have received Emergency Use Authorizations from the FDA for COVID-19 tests in the past. In August, the Cleveland Clinic received EUA for the SelfCheck COVID-19 TaqPath Multiplex PCR test, which uses a sample self-collection kit, and in mid-2020, Secaucus, New Jersey-based Quest received EUA for three SARS-CoV-2 tests that use nasal swab self-collection devices.

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