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US CDC Real-Time Reverse Transcription PCR Panel for Detection of Severe Acute Respiratory Syndrome Coronavirus 2
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US CDC Real-Time Reverse Transcription PCR Panel for Detection of Severe Acute Respiratory Syndrome Coronavirus 2
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Journal Article
US CDC Real-Time Reverse Transcription PCR Panel for Detection of Severe Acute Respiratory Syndrome Coronavirus 2
2020
Overview
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the etiologic agent associated with coronavirus disease, which emerged in late 2019. In response, we developed a diagnostic panel consisting of 3 real-time reverse transcription PCR assays targeting the nucleocapsid gene and evaluated use of these assays for detecting SARS-CoV-2 infection. All assays demonstrated a linear dynamic range of 8 orders of magnitude and an analytical limit of detection of 5 copies/reaction of quantified RNA transcripts and 1 x 10
50% tissue culture infectious dose/mL of cell-cultured SARS-CoV-2. All assays performed comparably with nasopharyngeal and oropharyngeal secretions, serum, and fecal specimens spiked with cultured virus. We obtained no false-positive amplifications with other human coronaviruses or common respiratory pathogens. Results from all 3 assays were highly correlated during clinical specimen testing. On February 4, 2020, the Food and Drug Administration issued an Emergency Use Authorization to enable emergency use of this panel.
Publisher
U.S. National Center for Infectious Diseases,Centers for Disease Control and Prevention
Subject
2019 novel coronavirus disease
/ Centers for Disease Control and Prevention, U.S
/ Coronavirus Infections - diagnosis
/ Coronavirus Infections - virology
/ Coronavirus Nucleocapsid Proteins
/ COVID-19
/ DNA
/ DNA Primers - chemical synthesis
/ Fluorescent Dyes - chemistry
/ Genomes
/ Humans
/ Nucleocapsid Proteins - genetics
/ Pneumonia, Viral - diagnosis
/ Real-Time Polymerase Chain Reaction - methods
/ Real-Time Polymerase Chain Reaction - standards
/ RNA
/ Severe acute respiratory syndrome coronavirus 2
/ Viruses
