Performance Comparison of a Duplex Implementation of the CDC EUA 2019-nCoV Assay with the Seegene Allplex-SARS-CoV-2 Assay for the Detection of SARS-CoV-2 in Nasopharyngeal Swab Samples

RT-PCR tests have become the gold standard for detecting the SARS-CoV-2 virus in the context of the COVID-19 pandemic. Because of the extreme number of cases in periodic waves of infection, there is a severe financial and logistical strain on diagnostic laboratories. For this reason, alternative imp...

Full description

Saved in:
Bibliographic Details
Published in:Methods and protocols 2022-09, Vol.5 (5), p.73
Main Authors: Jiménez, Karen Marcela, Fonseca-Mendoza, Dora Janeth, Morel, Adrien, Ortega-Recalde, Oscar, Contreras Bravo, Nora Constanza, Velandia-Piedrahita, Camilo Andres, Steevens, Adriana, Caldas, Luisa Daniela, Ribón, Juan Pablo, Sánchez, Martha, Restrepo, Carlos Martin, Cabrera, Rodrigo
Format: Article
Language:English
Subjects:
Acids
Automation
Coronaviruses
COVID-19
Disease control
Enzymes
Laboratories
molecular diagnostic
Pandemics
Performance evaluation
Polymerase chain reaction
Public health
Reagents
real-time PCR
Reference materials
Reproducibility
Ribonuclease P
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
Citations: Items that this one cites
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:RT-PCR tests have become the gold standard for detecting the SARS-CoV-2 virus in the context of the COVID-19 pandemic. Because of the extreme number of cases in periodic waves of infection, there is a severe financial and logistical strain on diagnostic laboratories. For this reason, alternative implementations and validations of academic protocols that employ the lowest cost and the most widely available equipment and reagents found in different regions are essential. In this study, we report an alternative implementation of the EUA 2019-nCoV CDC assay which uses a previously characterized duplex PCR reaction for the N1 and RNAse P target regions and an additional uniplex reaction for the N2 target region. Taking advantage of the Abbott m2000 Sample Preparation System and NEB Luna Universal Probe One-Step RT-qPCR kit, some of the most widely available and inexpensive nucleic acid extraction and amplification platforms, this modified test shows state-of-the-art analytical and clinical sensitivities and specificities when compared with the Seegene Allplex-SARS-CoV-2 assay. This implementation has the potential to be verified and implemented by diagnostic laboratories around the world to guarantee low-cost RT-PCR tests that can take advantage of widely available equipment and reagents.
ISSN:2409-9279
2409-9279
DOI:10.3390/mps5050073