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FDA Authorizes At-Home COVID-19 Tests

April 22, 2020
More than 50 diagnostic tests have received emergency use authorizations as officials stress the importance of ubiquitous testing.

On April 21, the Food and Drug Administration gave the Laboratory Corporation of America’s COVID-19 RT-PCR test an emergency use authorization. LabCorp’s test allows patients to collect their own samples at home. According to the FDA, the government body has issued more than 50 such authorizations for tests of the virus.

The procedure for the test involves a saline solution and a nasal swab. Patients collect a sample using the nasal swab and mail it to a LabCorp lab for it to be tested remotely. According to the FDA, LabCorb’s tests will be available in most states if consumers get a doctor’s order.

The FDA’s statement also included a note that the authorization does not authorize the at-home collection of samples using any other means than LabCorp’s swab, since other swabs might not be effective with existing tests. “We worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate” as samples taken at a doctor’s office, said FDA Commissioner Dr. Stephen Hahn. “With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” said Hahn.

According to LabCorp CEO Adam Schechter, the at-home kits should increase availability of tests while reducing the risk of transmitting the virus. Additionally, since the tests are self-administered, they require less personal protective equipment to be used compared to other tests, which are administered by clinicians. “Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time,” said Schechter in a statement.

The tests will be offered through LabCorp’s “Pixel” platform, where they’re currently listed for $119, but they’re not available to the general population yet.  A statement from LabCorp notes the tests are initially only available for medical workers and first responders. Another potential hurdle for the tests: LabCorp’s online platform for ordering tests is unavailable in New York, New Jersey, Maryland or Rhode Island due to state restrictions on ordering lab tests there.

The large number of emergency authorizations for coronavirus tests shows the urgency many government officials feel on ramping up testing for the virus. The White House, after issuing guidelines for governors to use while reopening their states, has publicly parred with governors about the availability of enough tests to accurately gauge how much of the virus remains in the population.

While the White House insists that the number of tests available is adequate, governors from both parties have disputed that. Larry Hogan, the Republican governor of Maryland, drew a rebuke from President Trump after news broke that Hogan’s wife had negotiated the delivery of half a million test kits from South Korea. The governor of New York, Andrew Cuomo, called for the federal government to coordinate interstate supply chains for the tests.

About the Author

EHS Today Staff

EHS Today's editorial staff includes:

Dave Blanchard, Editor-in-Chief: During his career Dave has led the editorial management of many of Endeavor Business Media's best-known brands, including IndustryWeekEHS Today, Material Handling & LogisticsLogistics Today, Supply Chain Technology News, and Business Finance. In addition, he serves as senior content director of the annual Safety Leadership Conference. With over 30 years of B2B media experience, Dave literally wrote the book on supply chain management, Supply Chain Management Best Practices (John Wiley & Sons, 2021), which has been translated into several languages and is currently in its third edition. He is a frequent speaker and moderator at major trade shows and conferences, and has won numerous awards for writing and editing. He is a voting member of the jury of the Logistics Hall of Fame, and is a graduate of Northern Illinois University.

Adrienne Selko, Senior Editor: In addition to her roles with EHS Today and the Safety Leadership Conference, Adrienne is also a senior editor at IndustryWeek and has written about many topics, with her current focus on workforce development strategies. She is also a senior editor at Material Handling & Logistics. Previously she was in corporate communications at a medical manufacturing company as well as a large regional bank. She is the author of Do I Have to Wear Garlic Around My Neck?, which made the Cleveland Plain Dealer's best sellers list.

Nicole Stempak, Managing Editor:  Nicole Stempak is managing editor of EHS Today and conference content manager of the Safety Leadership Conference.

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