NEW YORK – The US Food and Drug Administration told the public on Friday to stop using Lepu Medical Technology's SARS-CoV-2 Antigen Rapid Test Kit and its Leccurate SARS-CoV-2 Antibody Rapid Test Kit.
The tests haven't been authorized, cleared, or approved by the agency for distribution and use in the US. FDA said in a document posted on its website that it "believes there is likely a high risk of false results when using these tests" and that it "has serious concerns" about the tests' performance.
China-based Lepu Medical Technology is recalling both tests, which were distributed to pharmacies to be sold for at-home testing and were offered for sale directly to consumers.
The FDA recommended providers consider retesting their patients using a different SARS-CoV-2 diagnostic or antibody test if an inaccurate result from either test in the last two weeks is suspected. If the antigen testing was performed more than two weeks before and there's no reason to suspect a current SARS-CoV-2 infection, the FDA said a retest isn't necessary.
FDA also recommended test users speak with their healthcare providers if there are concerns about their test results and report any problems with either test to the FDA.
The antigen kit uses a nasal swab sample to detect SARS-CoV-2 antigens, while the antibody kit uses serum, plasma, or blood samples.