FDA recalls unauthorized at-home coronavirus rapid test over false results concerns

The Food and Drug Administration (FDA) has warned consumers to stop using an unauthorized COVID-19 at-home rapid test and antibody test over concerns that the kits may produce false results. The kits, produced by Lepu Medical Technology, were distributed to pharmacies to be sold to consumers for at-home testing and made available through direct sales despite not having FDA authorization. 

According to a safety communication issued by the FDA, the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) could result in false test results, which “may cause people harm including serious illness and death.” 

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The antigen test is conducted using a nasal swab, while the antibody test relies on serum, plasma or blood samples. The FDA said it has “serious concerns about the performance” of both tests. Health care providers who used the antigen test within the last two weeks and suspect an inaccurate result are advised to retest patients using a different kit. Those who used the antibody test recently and suspect a false result are also instructed to retest patients using a different kit. 

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The FDA has granted emergency use authorization to 380 tests and sample collection devices since the start of COVID-19.