Rapid Covid-19 diagnostic tests available without lab work, so.....

[pat_k]

6. Awaiting FDA Emergency Use Authorization (EUA) ??

The rapid test is one of two developed by BioMedomics.

Rapid: COVID-19 IgM-IgG

Standard: COVID-19 PCR Virus Detection Kit

According to 3/12 report "This week BioMedomics submitted an application to the FDA seeking emergency use authorization for the antibody test kit in the United States"

I'm not positive that "antibody test kit" refers to the rapid test or the standard PCR.

https://www.ncbiotech.org/news/biomedomics-seeks-fda-ok-covid-19-rapid-diagnostic

Test not yet available in U.S.
The antibody test is being used widely by researchers in several countries and by China’s Centers for Disease Control and Prevention to combat infections in that country.

More than half a million test kits have been sold in China, and the number is growing daily, Wang said. BioMedomics has a subsidiary in China that is manufacturing and distributing the kits there.

The test recently received CE Mark-IVD certification for use in Europe and is being sold in Italy, the world’s current hot spot for the outbreak.

However, the test has not been approved by the U.S. Food and Drug Administration for use in the United States.

This week BioMedomics submitted an application to the FDA seeking emergency use authorization for the antibody test kit in the United States, Wang said. He doesn’t know if or when the test will be approved for sale but said it’s important to get the test on the market immediately to help stem the spread of COVID-19.

“In an outbreak, you need a fast (diagnostic) answer to isolate people,” he said. “Now is the time to deploy this. We need to get it onto the market as soon as possible.”