FDA Approves First OTC COVID-19 Test Collection Kit

The FDA has approved the first direct-to-consumer coronavirus disease 2019 (COVID-19) test home collection kit.

The COVID-19 pandemic has caused over 1.5 million deaths and there have been more than 68.1 million confirmed cases worldwide, according to the World Health Organization. Rapid, reliable testing is necessary to control the COVID-19 pandemic.

The first direct-to-consumer test, developed by LabCorp, allows a patient to self-collect a nasal swab at home and send that sample for testing to LabCorp. Positive or invalid test results are delivered to the patient by a health care provider over the phone while negative test results are delivered via email or online portal.

“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,” said Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, 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 that step from the process, allowing anyone to collect their sample and send it to the lab for processing.”

The collection kit can be purchased online or in stores without a prescription by anyone 18 years of age or older. The kit allows users to access information about their COVID-19 infection status and to determine whether self-quarantine is appropriate.

REFERENCE

Coronavirus (COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19 Test System [News Release] December 9, 2020; Silver Spring, MD. Accessed December 10, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-direct-consumer-covid-19-test system?utm_medium=email&utm_source=govdelivery.