Página 39 documento de la FDA (
U.S. Food and Drug Administration)
https://www.fda.gov/media/134922/download
Performance Characteristics
Analytical Performance:
Limit of Detection (LoD):
LoD studies determine the lowest detectable concentration of 2019-nCoV at which approximately 95%
of all (true positive) replicates test positive. The LoD was determined by limiting dilution studies using
characterized samples.
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. 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 ThemoFisher Scientific TaqPath™ 1-Step RT-qPCR Master Mix, CG (Cat# A15299) on
the Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument according to the CDC 2019-nCoV RealTime RT-PCR Diagnostic Panel instructions for use.
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