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Validation of a Methodology for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 in Saliva by Real-Time Reverse Transcriptase-PCR

In January 2021, the Chilean city of Concepción experienced a second wave of coronavirus 2019 (COVID-19) while in early April 2021, the entire country faced the same situation. This outbreak generated the need to modify and validate a method for detecting severe acute respiratory syndrome coronaviru...

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Autores principales: Escobar, Daniel F., Díaz, Pablo, Díaz-Dinamarca, Diego, Puentes, Rodrigo, Alarcón, Pedro, Alarcón, Bárbara, Rodríguez, Iván, Manzo, Ricardo A., Soto, Daniel A., Lamperti, Liliana, Díaz, Janepsy, García-Escorza, Heriberto E., Vasquez, Abel E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8674452/
https://www.ncbi.nlm.nih.gov/pubmed/34926372
http://dx.doi.org/10.3389/fpubh.2021.743300
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author Escobar, Daniel F.
Díaz, Pablo
Díaz-Dinamarca, Diego
Puentes, Rodrigo
Alarcón, Pedro
Alarcón, Bárbara
Rodríguez, Iván
Manzo, Ricardo A.
Soto, Daniel A.
Lamperti, Liliana
Díaz, Janepsy
García-Escorza, Heriberto E.
Vasquez, Abel E.
author_facet Escobar, Daniel F.
Díaz, Pablo
Díaz-Dinamarca, Diego
Puentes, Rodrigo
Alarcón, Pedro
Alarcón, Bárbara
Rodríguez, Iván
Manzo, Ricardo A.
Soto, Daniel A.
Lamperti, Liliana
Díaz, Janepsy
García-Escorza, Heriberto E.
Vasquez, Abel E.
author_sort Escobar, Daniel F.
collection PubMed
description In January 2021, the Chilean city of Concepción experienced a second wave of coronavirus 2019 (COVID-19) while in early April 2021, the entire country faced the same situation. This outbreak generated the need to modify and validate a method for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in saliva, thereby expanding the capacity and versatility of testing for COVID-19. This study was conducted in February 2021 in the Chilean city of Concepción during which time, the town was under total quarantine. The study participants were mostly symptomatic (87.4%), not hospitalized, and attended care centers because of their health status rather than being asked by the researchers. People coming to the health center in Concepción to be tested for COVID-19 (via reverse transcriptase polymerase chain reaction [RT-PCR]) from a specimen of nasopharyngeal swab (NPS) were then invited to participate in this study. A total of 131 participants agreed to sign an informed consent and to provide saliva and NPS specimens to validate a method in terms of sensitivity, specificity, and statistical analysis of the cycle threshold (Ct) values from the RT-PCR. Calculations pertaining to the 127 participants who were ultimately included in the analysis showed sensitivity and specificity at 94.34% (95% CI: 84.34–98.82%) and 98.65% (95% CI: 92.70–99.97%), respectively. The saliva specimen showed a performance comparable to NPS as demonstrated by the diagnostic parameters. This RT-PCR method from the saliva specimen is a highly sensitive and specific alternative compared to the reference methodology, which uses the NPS specimen. This modified and validated method is intended for use in the in vitro diagnosis of SARS-CoV-2, which provides health authorities in Chile and local laboratories with a real testing alternative to RT-PCR from NPS.
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spelling pubmed-86744522021-12-17 Validation of a Methodology for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 in Saliva by Real-Time Reverse Transcriptase-PCR Escobar, Daniel F. Díaz, Pablo Díaz-Dinamarca, Diego Puentes, Rodrigo Alarcón, Pedro Alarcón, Bárbara Rodríguez, Iván Manzo, Ricardo A. Soto, Daniel A. Lamperti, Liliana Díaz, Janepsy García-Escorza, Heriberto E. Vasquez, Abel E. Front Public Health Public Health In January 2021, the Chilean city of Concepción experienced a second wave of coronavirus 2019 (COVID-19) while in early April 2021, the entire country faced the same situation. This outbreak generated the need to modify and validate a method for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in saliva, thereby expanding the capacity and versatility of testing for COVID-19. This study was conducted in February 2021 in the Chilean city of Concepción during which time, the town was under total quarantine. The study participants were mostly symptomatic (87.4%), not hospitalized, and attended care centers because of their health status rather than being asked by the researchers. People coming to the health center in Concepción to be tested for COVID-19 (via reverse transcriptase polymerase chain reaction [RT-PCR]) from a specimen of nasopharyngeal swab (NPS) were then invited to participate in this study. A total of 131 participants agreed to sign an informed consent and to provide saliva and NPS specimens to validate a method in terms of sensitivity, specificity, and statistical analysis of the cycle threshold (Ct) values from the RT-PCR. Calculations pertaining to the 127 participants who were ultimately included in the analysis showed sensitivity and specificity at 94.34% (95% CI: 84.34–98.82%) and 98.65% (95% CI: 92.70–99.97%), respectively. The saliva specimen showed a performance comparable to NPS as demonstrated by the diagnostic parameters. This RT-PCR method from the saliva specimen is a highly sensitive and specific alternative compared to the reference methodology, which uses the NPS specimen. This modified and validated method is intended for use in the in vitro diagnosis of SARS-CoV-2, which provides health authorities in Chile and local laboratories with a real testing alternative to RT-PCR from NPS. Frontiers Media S.A. 2021-12-02 /pmc/articles/PMC8674452/ /pubmed/34926372 http://dx.doi.org/10.3389/fpubh.2021.743300 Text en Copyright © 2021 Escobar, Díaz, Díaz-Dinamarca, Puentes, Alarcón, Alarcón, Rodríguez, Manzo, Soto, Lamperti, Díaz, García-Escorza and Vasquez. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Public Health
Escobar, Daniel F.
Díaz, Pablo
Díaz-Dinamarca, Diego
Puentes, Rodrigo
Alarcón, Pedro
Alarcón, Bárbara
Rodríguez, Iván
Manzo, Ricardo A.
Soto, Daniel A.
Lamperti, Liliana
Díaz, Janepsy
García-Escorza, Heriberto E.
Vasquez, Abel E.
Validation of a Methodology for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 in Saliva by Real-Time Reverse Transcriptase-PCR
title Validation of a Methodology for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 in Saliva by Real-Time Reverse Transcriptase-PCR
title_full Validation of a Methodology for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 in Saliva by Real-Time Reverse Transcriptase-PCR
title_fullStr Validation of a Methodology for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 in Saliva by Real-Time Reverse Transcriptase-PCR
title_full_unstemmed Validation of a Methodology for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 in Saliva by Real-Time Reverse Transcriptase-PCR
title_short Validation of a Methodology for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 in Saliva by Real-Time Reverse Transcriptase-PCR
title_sort validation of a methodology for the detection of severe acute respiratory syndrome coronavirus 2 in saliva by real-time reverse transcriptase-pcr
topic Public Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8674452/
https://www.ncbi.nlm.nih.gov/pubmed/34926372
http://dx.doi.org/10.3389/fpubh.2021.743300
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