FDA Authorizes First Direct-to-Consumer COVID-19 Test System
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On Dec 9th FDA authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. This product, which is authorized as the first COVID-19 direct to consumer (non-prescription) test system, allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp.

Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are delivered via email or online portal. This home sample collection kit can be purchased online or in a store.

It is intended to enable users to access information about their COVID-19 infection status that could aid with determining if self-isolation is appropriate and to assist with health care decisions after discussion with a health care professional.

Source:
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-direct-consumer-covid-19-test-system
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