The FDA is warning the public to stop using two COVID-19 rapid testing kits over the potentially high risk of inaccurate results. The agency says the tests aren’t authorized, but were distributed to pharmacies and sold directly to consumers in the US. A false result may make someone think they have COVID-19 when they’re not infected or it may produce a negative result in an individual who is infected.
The advisory involves two rapid testing kits: the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) and the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit. The FDA says that it has ‘serious concerns’ about how well these two unauthorized test kits perform when it comes to test results, noting that it has reason to believe they have high odds of producing false results.
Both kits come from Lepu Medical Technology, which is recalling the products. The FDA advises the public and health care providers to stop using these kits, noting that some patients may need to be retested with a different authorized product. Those who were tested more than two weeks ago don’t need to be retested if there’s no reason to suspect they may have contracted COVID-19.
The antigen rapid test kit involves a nasal swab, while the antibody test kit uses blood, serum, or plasma samples. The agency explains the risk of false results, noting that someone who gets a false positive may not be treated for their actual illness in a timely manner, while someone who gets a false negative result may not be treated for COVID-19 until it develops to a more severe stage.
As well, someone who receives a false-negative result may continue in their daily activities, potentially spreading the virus to other people. Authorized testing kits are available from a number of companies, including at-home testing kits and ones provided at pharmacies and healthcare facilities.