FDA应该还没有批这种公司 看这里

It’s important to note that these tests have not been reviewed or validated by the FDA, unlike those molecular tests that are included in the organization’s emergency use category. Instead, the FDA “does not intend to object to the development and distribution by commercial manufacturers” of these tests, provided they meet a number of criteria, including qualifying the results of their reported test results with the following information:

• This test has not been reviewed by the FDA.
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

https://techcrunch.com/2020/03/27/the-fda-just-okayed-multiple-15-minute-blood-tests-to-screen-for-coronavirus-but-there-are-caveats/