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Quest Diagnostics Gets FDA Emergency Use Authorizations for DTC COVID-19 Tests, Self-Collection Kit

NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations for three direct-to-consumer SARS-CoV-2 tests from Quest Diagnostics, as well as a home sample collection kit for use with the tests.

The three PCR-based tests — Quest RC COVID-19 PCR DTC, Quest PF COVID-19 PCR DTC, and Quest COVID-19 PCR DTC — are all designed for the qualitative detection of nucleic acids from SARS-CoV-2 in anterior nasal swab specimens self-collected using the newly authorized Quest COVID-19 PCR Test Home Collection Kit.

The Quest RC COVID-19 PCR DTC may also be used with pooled samples containing up to six individual specimens. The Quest PF COVID-19 PCR DTC can accommodate pools of up to five specimens, and the Quest COVID-19 PCR DTC may be used with pools of up to four specimens.

Use of all three tests is limited to labs designated by Secaucus, New Jersey-based Quest and CLIA-certified to perform high-complexity tests, according to the FDA.