COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Issues Public Safety Communication, Warning Public and Healthcare Providers About COVID-19 Tests Sold by Lepu Technology

FDA maze of regulations

New FDA warnings for unauthorized COVID-19 tests demonstrate the FDA’s continued attention to unreliable COVID-19 testing

The US Food and Drug Administration (FDA) has issued a public safety communication, warning healthcare providers and members of the public about the risks of false results with two COVID-19 tests that are marketed for at-home use. The safety communication accompanies a Class I recall by the FDA—the most serious type of recall.

In its safety communication, the FDA identified Lepu Technology’s SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) as the two tests that are being recalled. Neither test had received FDA authorization or approval, and both had been distributed to pharmacies and marketed directly to the consumer.

The FDA recommends that these two tests stop being used and that anyone who suspects they may have received an inaccurate test result within the last two weeks, after using one of these tests, should be retested using another test.

Two main reasons were cited for the recall and safety communication for these two tests, according to the FDA. The first reason provided is the “high risk of false results” that both tests have, including both false-positive and false-negative results that can result in misdiagnosis. The second reason cited is the lack of “authorization, clearance, or approval from the FDA”.

This recent warning by the FDA shows that the distribution of unreliable and unapproved COVID-19 tests remains an ongoing problem, and it also shows the FDA’s continuing attention to unreliable COVID-19 tests.

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