The FDA has warned the consumers to not use any unauthorized at-home Covid-19 antibody test and rapid test due to concerns that these kits might generate false results. Produced by Lepu Medical Technology, these kits were circulated to the pharmacies for being sold to the consumers to conduct at-home test and was made available via direct sales in spite of not having a proper FDA authorization.
As per one safety communication released by the FDA, the Leccurate SARS-CoV-2 Antobidy Rapid Test Kit and SARS-CoV-2 Antigen Rapid Test Kit from Lepu Medical Technology may product false results that might cause harm to the consumers, including severe illness and death.
The antibody test is conducted on blood samples, plasma or serum while the antigen test depends on utilizing nasal swab. The FDA says that it has concerns related to the performance of these tests. The healthcare professionals who have used antigen test in the past two weeks and think they have inaccurate results are highly advised to retest the patients using another kit. The ones who recently used an antibody test and believe that they have false results are also advised to retest the patients using another kit.
Notably, the FDA has granted authorization for emergency use to about 380 sample collection tools and tests since the beginning of the pandemic.