federalexpression

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PCR Test Calibrated Without C19 Sample

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CDC Document “CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel” admits no C19 virus isolated.

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. Samples were extracted using the QIAGEN EZ1
Advanced XL instrument and EZ1 DSP Virus Kit (Cat# 62724) and manually with the QIAGEN DSP Viral
RNA Mini Kit (Cat# 61904). Real-Time RT-PCR assays were performed using the Thermo Fisher Scientific
TaqPath™ 1-Step RT-qPCR Master Mix, CG (Cat# A15299) on the Applied Biosystems™ 7500 Fast Dx RealTime PCR Instrument according to the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel instructions
for use.

80 Page doc << Download

Let me interpret this… We didn’t have any samples so we fudged it! Follow the science!

Written by federalexpression

July 30, 2021 at 5:24 pm

Posted in Uncategorized

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