The U.S. Food and Drug Administration (FDA) has issued a warning against the use of the SARS-CoV-2 Antigen Rapid Test Kit and Leccurate SARS-CoV-2 Antibody Rapid Test Kit (immunochromatography of colloidal gold). He suspects that these tests are not working as they should. According to the FDA, they even have a high risk of false results, both tests for SARS-CoV-2 Antigen Rapid Test Kit and tests for Leccurate SARS-CoV-2 Antibody Rapid Test (immunochromatography of colloidal gold) by Lepu Medical Technology.

The FDA further states that none of the tests listed above have been approved by the FDA or released for sale by the FDA. Nevertheless, these tests were delivered to pharmacies and offered to consumers. Lepu Medical Technology is now withdrawing its tests from sale.

The FDA issued a set of recommendations that can be summarized as follows:

• Stop using Lepu Medical Technology tests for SARS-CoV-2 antigens and Leccurate SARS-CoV-2 antibody test.
• If you have already used these tests in the past fortnight and are doubtful about the result, then take another test again, or contact your doctor.
• Report any problems with these tests directly to the FDA.

You can find more detailed information on this topic here. We also drew all the information above from this article.

In the Czech Republic, these tests are also on the market and have even obtained an MZCR exemption under §4 para. 8 Cabinet Order No.56/2015 Coll.

The US continues to explore tests and warns against tests under the name Innova COVID-19 Self-Test Kit (3T Configuration), Innova Medical Group SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration) and Innova Medical Group SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration). 

The FDA recommends essentially the same procedure for users as for the aforementioned tests from Lepu Medical Technology. More details can be found here.