The FDA is warning the audience to stop using two Rapid Test Kits Covid-19 on the potentially high risk of inaccurate results. The agency says that the tests are not authorized, but were distributed to pharmacies and sold directly to consumers in the United States. A false result can make someone think they have Covid-19 when they are not infected or can produce a negative result in an individual who is infected.
The adviser involves two fast test kits: the RV-COV-2 SARS-COV-2 antibody test kit (colloidal gold immunochromatography) and the Lepu Medical Technology SARS-COV-2 Antigen Test Kit. The FDA says that it has “serious concerns” about how well these two unauthorized test kits are performed when it comes to the results of the tests, noting that it has reason to believe that they have a high probability of producing false results.
Both kits come from Lepu medical technology, which is remembered products. The FDA advises public and health care providers to stop using these kits, noting that some patients may need to be returned with a different authorized product. Those who were tested more than two weeks ago do not need to be returned if there is no reason to suspect that they may have hired Covid-19.
The rapid antigen 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 its real disease in a timely manner, while someone who gets a false negative result may not be treated by Covid-19 until it develops For a more severe stage.
In addition, someone who receives a false negative result can continue in their daily activities, potentially disseminating the virus to other people. The authorized test kits are available from several companies, including home test kits and those provided in pharmacies and sanitary facilities.