https://www.fda.gov/media/134922/download
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Since no
quantified virus isolates of the 2019-nCoV were available for CDC use at the time the test was developed
and this study conducted, 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