USFDA Authorized First Direct-to-Consumer COVID-19 Test System

The USFDA on 9th December 2020 has authorized LabCorp’s Pixel COVID-19 test home collection kit for use by any individual 18 years and older without a prescription. This is the first product to be authorized as the first COVID-19 direct-to-consumer test system. This test allows the individual to self-collect a nasal swab sample at home and then send the sample for testing to LabCorp. The negative test results are delivered via email or an online portal.

Positive or invalid results are delivered to the user by a phone call from a health care provider. The average time to deliver results is currently 1-2 days from when the sample s received at the lab. The Pixel by LabCorp is a molecular test also known as reverse polymer chain reaction test or a nucleic acid amplification test. The home sample collection kit can be purchased online (in the USA) or in a store without a prescription.

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Ref link: 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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