After Dec. 31rst, the CDC will be withdrawing its request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCov) Real-Time RT-PCR Diagnostic Panel, according to the CDC press release statement.
To prepare for the change the CDC are recommending the use of different clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test.
The CDC did not list a specific reason why it was withdrawing the Real-Time RT-PCR Diagnostic Panel test. Was the test defective? Well, it’s safe to say that we may never know, as the CDC has been very hesitant about providing data. However, according to one report, the reason was because the “original test (known as CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel) was falsely picking up influenza infections as COVID cases, though. Rather, it was only looking for SARS-CoV-2 and ignoring genetic material from other viruses entirely.” That sounds like the original test cannot tell the difference from COVID and the Flu.
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