OK let's get this started:
On Monday,
February 3, 2020, CDC submitted an Emergency Use Authorization (EUA) package to the U.S. Food and Drug Administration (FDA) in order to expedite FDA permitted use of the CDC diagnostic panel in the United States. The EUA process enables FDA to consider and authorize the use of unapproved, but potentially life-saving medical or diagnostic products during a public health emergency. The U.S. Secretary of Health and Human Services declared the SARS-CoV-2 virus a U.S. public health emergency on Friday,
January 31, 2020. FDA issued the EUA on
February 4, 2020. IRR began distribution of the test kits to states, but shortly thereafter performance issues were identified related to a problem in the manufacturing of one of the reagents which led to laboratories not being able to verify the test performance. CDC is remanufacturing the reagents with more robust quality control measures. New tests will be distributed once this issue has been addressed. CDC continues to perform initial and confirmatory testing.
Serology Test for COVID-19
...
The serology test will look for the presence of antibodies, which are specific proteins made in response to infections. …..
Initial work to develop a serology test for SARS-CoV-2 is underway at CDC. In order to develop the test, CDC needs blood samples from people who had COVID-19 at least 21 days after their symptoms first started. ….
Where are these kits coming from?
https://www.voanews.com/science-health/coronavirus-outbreak/million-covid-19-test-kits-expected-us-labs-soon-hhs-chief-says
Here?
https://www.yahoo.com/entertainment/chinese-billionaire-donate-coronavirus-test-173814987.html
I do wonder how the Chines billionaire got 500.000 kits , how can they be spared and how good are they? I'm still searching.