On Monday, February 3, 2020, CDC submitted an Emergency Use Authorization (EUA) their own product package to the U.S. Food and Drug Administration (FDA) to expedite FDA permitted use in the United States.” This is to “authorize the use of unapproved, but potentially life-saving medical or diagnostic products during a public health emergency.”
The next day on February 4, 2020, the FDA issued the EUA and the CDC release their “CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-RCR Diagnostic Panel” which is “intended for the presumptive qualitative detection of nucleic acid from the 2019-nCoV…Positive results are indicative of active infection with 2019-nCoV but do not rule out bacterial infection or co-infection with other viruses.”
During the following 21 days after release of the CDC “exclusive” kit, “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.” By then the virus had spread across the country. The CDC test kit fiasco had hindered the public health response to the virus.
Which in May 2021 a FOIA revealed that the tests were “poorly designed and came with erroneous instructions that made it doubly difficult for labs to rely on the test’s results” and the CDC lab scientists knew that the tests failed 33% of the time but didn’t stop it’s release.