
FDA authorized Quest Diagnostics COVID-19 Nasal Specimen Self-Collection Kit for emergency use
On May 28, 2020, Quest Diagnostics announced it had received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Quest Diagnostics Self-collection Kit for COVID-19. The self-collection kit is for individuals to self-collect a nasal specimen at home or in a healthcare setting when determined to be appropriate by a healthcare provider. The self-collection kit allows an individual to swab the front part of the nostril and may be used on children (supervised by an adult) as well as adults. Specimens are shipped overnight via FedEx at room temperature.
The self-collection kit allows an individual to swab the front part of the nostril and may be used on children (supervised by an adult) as well as adults. Specimens are shipped overnight via FedEx at room temperature (without a frozen cold pack). Specimens collected using the kit may be tested with the Quest Diagnostics SARS-CoV-2 RT-PCR test that received an Emergency Use Authorization in March. RT-PCR testing aids in diagnosing infection with SARS-CoV-2, the virus that causes COVID-19.
Quest shared data with FDA that indicate that the self-collection kit offers a consumer-friendly approach to high quality diagnostic testing for COVID-19. Quest Diagnostics already tested specimens using a similar collection method in real-world settings in drive-thru and other onsite COVID-19 testing sites across the United States. The self-collection kit was developed to be very consumer friendly, with the specimen collected at home and without the need to directly involve a healthcare professional to perform or observe the collection.
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Source: Quest Diagnostics
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