FDA authorizes first direct-to-consumer COVID-19 test system
FDA issued an EUA (PDF) to LabCorp for its Pixel COVID-19 Test Home Collection Kit for use with LabCorp’s COVID-19 RT-PCR Test. The Pixel COVID-19 Test Home Collection Kit:
- Is the first COVID-19 direct-to-consumer (non-prescription) test system, allowing a person to self-collect a nasal sample in their home and then send the sample to LabCorp for testing.
- Can be used by anyone aged 18 or over.
- Can be purchased online or in a store without a prescription.
A health care provider delivers positive or invalid test results to the user by phone call. Users may access negative test results by an online portal or by email. Read the FDA news release (December 9, 2020)
Diagnostic test EUAs
As of today, 300 tests and sample collection devices are authorized by FDA under EUAs; these include 230 molecular tests and sample collection devices, 61 antibody tests, and 9 antigen tests. Also see: Coronavirus Testing Basics
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