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FDA Warns About Unauthorized Fraudulent COVID-19 Tests

By Brian Orelli, PhD - Mar 20, 2020 at 7:44PM

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The agency hasn't approved any in-home test kits yet.

The Food and Drug Administration (FDA) is warning consumers about the marketing of unauthorized fraudulent in-home test kits designed for COVID-19, the disease caused by the new coronavirus. The FDA is worried about potential false-negative results from the kits. "They may keep some patients from seeking care or delay necessary medical treatment," the agency warned in a statement.

The FDA plans to scan ports of entry, including international mail facilities, for fake tests. It's also calling on the public to report fraudulent test kits for COVID-19 if they see them.

"We will continue to aggressively pursue those who place the public health at risk and hold bad actors accountable," the agency said.

Tube of blood marked positive for coronavirus

Image source: Getty Images.

The FDA hasn't approved any test kits for use in homes, although it's working with test-makers on taking in-home samples that can be shipped to labs to be tested. Privately held Everlywell, Nurx, and Carbon Health have all started shipping in-home sample collection kits.

The FDA has authorized tests from Abbott Labs (ABT 3.05%), Thermo Fisher Scientific (TMO 0.78%), and Roche (RHHBY 4.07%) under its Emergency Use Authorization program. The agency also gives leeway to diagnostic laboratories to develop their own tests for use in their facilities.

Despite the ramp up in authorization and production of tests, there still aren't enough tests for mass screening in the U.S., Roche's CEO Severin Schwan warned earlier this week. The lack of available tests is likely making some people desperate to get tested any way they can -- thus the FDA's warning on Friday to be on the lookout for unauthorized fraudulent test kits.

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