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Validation of a Methodology for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Saliva by Real-Time RT-PCR

61 Pages Posted: 26 May 2021

See all articles by Daniel F. Escobar

Daniel F. Escobar

Institute of Public Health of Chile - Section of Biotechnology

Pablo Díaz

Institute of Public Health of Chile - Section of Biotechnology

Diego Diaz-Dinamarca

Institute of Public Health of Chile - Section of Biotechnology

Rodrigo Puentes

Institute of Public Health of Chile - National Agency for Medical Devices, Innovation and Development (ANDID)

pedro alarcon

Hospital Guillermo Grant Benavente

Barbara Alarcon

Hospital Guillermo Grant Benavente

Iván Rodríguez

Hospital Guillermo Grant Benavente

Ricardo Manzo

Institute of Public Health of Chile - Section of Biotechnology

Daniel A Soto

Institute of Public Health of Chile - Section of Biotechnology

Liliana Lamperti

Universidad de Concepción - Laboratorio de Diagnóstico Molecular y Proteómica OMICs

Janepsy Diaz

Institute of Public Health of Chile - National Agency for Medical Devices, Innovation and Development (ANDID)

Heriberto E. Garcia-Escorza

Institute of Public Health of Chile; Ministry of Health, Chile

Abel E. Vásquez

Institute of Public Health of Chile - Section of Biotechnology

More...

Abstract

Background: In January 2021, the city of Concepción in Chile suffered a second wave of COVID-19, while in early April 2021, all of Chile was facing the same situation. This generated the need to modify and validate a methodology for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in saliva, thereby expanding the capacity and versatility of testing.

Methods: People who came to the health center in Concepción city to perform a test of real-time reverse transcription polymerase chain reaction (RT-PCR) from a nasopharyngeal swab (NPS) specimen were invited to participate in this study. A total of 131 participants agreed to sign an informed consent and provide saliva and NPS specimens to validate a methodology in terms of sensitivity, specificity, and statistical analysis of the Ct values from RT-PCR.

Findings: Calculations pertaining to the 127 participants who were ultimately included in the analysis were the following: sensitivity at 94·34% (95% CI: 84·34%-98·82%) and specificity at 98·65% (95% CI: 92·70%-99·97%). The saliva specimen showed a very similar performance to NPS as demonstrated with the diagnostic parameters.

Interpretations: This RT-PCR methodology from the saliva specimen is a highly sensitive and specific alternative as compared to the reference methodology, which uses an NPS specimen. This modified and validated methodology 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 alternative for RT-PCR from NPS.

Funding Information: Health Public Institute of Chile.

Declaration of Interests: All authors declare no competing interests.

Ethics Approval Statement: The study had the authorization of the Scientific Ethics Committee of the Health Service of Concepción, Chile Number 20-01-02. Parents or legal guardians for volunteers under the age of 18 signed the informed consent.

Suggested Citation

Escobar, Daniel F. and Díaz, Pablo and Diaz-Dinamarca, Diego and Puentes, Rodrigo and alarcon, pedro and Alarcon, Barbara and Rodríguez, Iván and Manzo, Ricardo and Soto, Daniel A and Lamperti, Liliana and Diaz, Janepsy and Garcia-Escorza, Heriberto E. and Vásquez, Abel E., Validation of a Methodology for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Saliva by Real-Time RT-PCR. Available at SSRN: https://ssrn.com/abstract=3854028 or http://dx.doi.org/10.2139/ssrn.3854028

Daniel F. Escobar

Institute of Public Health of Chile - Section of Biotechnology ( email )

Chile

Pablo Díaz

Institute of Public Health of Chile - Section of Biotechnology

Chile

Diego Diaz-Dinamarca

Institute of Public Health of Chile - Section of Biotechnology ( email )

Chile

Rodrigo Puentes

Institute of Public Health of Chile - National Agency for Medical Devices, Innovation and Development (ANDID) ( email )

Chile

Pedro Alarcon

Hospital Guillermo Grant Benavente ( email )

Chile

Barbara Alarcon

Hospital Guillermo Grant Benavente ( email )

Chile

Iván Rodríguez

Hospital Guillermo Grant Benavente

Chile

Ricardo Manzo

Institute of Public Health of Chile - Section of Biotechnology ( email )

Chile

Daniel A Soto

Institute of Public Health of Chile - Section of Biotechnology

Chile

Liliana Lamperti

Universidad de Concepción - Laboratorio de Diagnóstico Molecular y Proteómica OMICs ( email )

Chile

Janepsy Diaz

Institute of Public Health of Chile - National Agency for Medical Devices, Innovation and Development (ANDID) ( email )

Chile

Heriberto E. Garcia-Escorza

Institute of Public Health of Chile ( email )

Chile

Ministry of Health, Chile ( email )

Santiago
Chile

Abel E. Vásquez (Contact Author)

Institute of Public Health of Chile - Section of Biotechnology ( email )

Chile

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