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The FDA approves the primary COVID-19 take a look at instantly on the shopper

December 10, 2020

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The FDA has approved LabCorp’s Pixel COVID-19 Test Home Collection Kit ⎼⎼ the first COVID-19 test kit for direct consumption ⎼⎼ for use by people aged 18 and over.

The test kit allows a person to take a nasal swab sample at home and send it to LabCorp for testing, according to the FDA. Positive or invalid test results are then communicated to the user by phone call from a health care provider, while negative test results are communicated via email or an online portal.

According to the FDA, the kit can be purchased online or at a store without a prescription. It also gives users access to information about their COVID-19 infection status, which they can use to determine if they need to self-isolate and, after speaking with a healthcare professional, help them make health care decisions.

“This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription.” Jeff Shuren, MD, JD, The director of the FDA Center for Devices and Radiological Health said in a press release. “While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes this step from the process so anyone can collect their sample and send it to the lab for processing.”

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