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Monday, October 12, 2020 6:34:52 PM
“The analytical sensitivity of the rRT-PCR assays contained in the CDC 2019 Novel Coronavirus (2019- nCoV) Real-Time RT-PCR Diagnostic Panel were determined in Limit of Detection studies. Since no quantified virus isolates of the 2019-nCoV are currently available, assays designed for detection of the 2019-nCoV RNA were tested with characterized stocks of in vitro transcribed full length RNA (N gene; GenBank accession: MN908947.2) of known titer (RNA copies/µL) spiked into a diluent consisting of a suspension of human A549 cells and viral transport medium (VTM) to mimic clinical specimen.”
What does this quote mean? No one has isolated the virus from sick people? They are testing us based on what they think a coronavirus might be? What are the RBLs testing B on. The words are right in the quote buried on pg 39. No quantified virus isolates are currently available. Quantified means measured. What is an isolate? WTF is going on?
https://www.fda.gov/media/134922/download
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