Anonymous ID: 60893b April 28, 2021, 5:27 p.m. No.13535483   🗄️.is 🔗kun

>>13534999

>>13535049

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 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.

 

pg 43/80

https://www.fda.gov/media/134922/download