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Validation and deployment of a direct saliva real-time RT-PCR test on pooled samples for COVID-19 surveillance testing

A direct, real-time reverse transcriptase PCR test on pooled saliva was validated in 2,786 participants against oropharyngeal swabs. Among asymptomatic/pre-symptomatic participants, the test was found to be in 99.21% agreement and 45% more sensitive than contemporaneous oropharyngeal swabs. The test...

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Autores principales: Rainey, Amanda, Pierce, Austin, Deng, Xiaoyun, Actis, Luis A., Smith, Philip, Kiss, Andor J., Wilson, Timothy J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8718011/
https://www.ncbi.nlm.nih.gov/pubmed/34969053
http://dx.doi.org/10.1371/journal.pone.0261956
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author Rainey, Amanda
Pierce, Austin
Deng, Xiaoyun
Actis, Luis A.
Smith, Philip
Kiss, Andor J.
Wilson, Timothy J.
author_facet Rainey, Amanda
Pierce, Austin
Deng, Xiaoyun
Actis, Luis A.
Smith, Philip
Kiss, Andor J.
Wilson, Timothy J.
author_sort Rainey, Amanda
collection PubMed
description A direct, real-time reverse transcriptase PCR test on pooled saliva was validated in 2,786 participants against oropharyngeal swabs. Among asymptomatic/pre-symptomatic participants, the test was found to be in 99.21% agreement and 45% more sensitive than contemporaneous oropharyngeal swabs. The test was then used for surveillance testing on 44,242 saliva samples from asymptomatic participants. Those whose saliva showed evidence of SARS-CoV-2 within 50 cycles of amplification were referred for confirmatory testing, with 87% of those tested by nasal swab within 72 hours receiving a positive diagnostic result on Abbott ID NOW or real-time PCR platforms. Median Ct values on the saliva PCR for those with a positive and negative confirmatory tests was 30.67 and 35.92 respectively, however, binary logistic regression analysis of the saliva Ct values indicates that Ct thresholds as high as 47 may be useful in a surveillance setting. Overall, data indicate that direct RT-PCR testing of pooled saliva samples is an effective method of SARS-CoV-2 surveillance.
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spelling pubmed-87180112021-12-31 Validation and deployment of a direct saliva real-time RT-PCR test on pooled samples for COVID-19 surveillance testing Rainey, Amanda Pierce, Austin Deng, Xiaoyun Actis, Luis A. Smith, Philip Kiss, Andor J. Wilson, Timothy J. PLoS One Research Article A direct, real-time reverse transcriptase PCR test on pooled saliva was validated in 2,786 participants against oropharyngeal swabs. Among asymptomatic/pre-symptomatic participants, the test was found to be in 99.21% agreement and 45% more sensitive than contemporaneous oropharyngeal swabs. The test was then used for surveillance testing on 44,242 saliva samples from asymptomatic participants. Those whose saliva showed evidence of SARS-CoV-2 within 50 cycles of amplification were referred for confirmatory testing, with 87% of those tested by nasal swab within 72 hours receiving a positive diagnostic result on Abbott ID NOW or real-time PCR platforms. Median Ct values on the saliva PCR for those with a positive and negative confirmatory tests was 30.67 and 35.92 respectively, however, binary logistic regression analysis of the saliva Ct values indicates that Ct thresholds as high as 47 may be useful in a surveillance setting. Overall, data indicate that direct RT-PCR testing of pooled saliva samples is an effective method of SARS-CoV-2 surveillance. Public Library of Science 2021-12-30 /pmc/articles/PMC8718011/ /pubmed/34969053 http://dx.doi.org/10.1371/journal.pone.0261956 Text en © 2021 Rainey et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Rainey, Amanda
Pierce, Austin
Deng, Xiaoyun
Actis, Luis A.
Smith, Philip
Kiss, Andor J.
Wilson, Timothy J.
Validation and deployment of a direct saliva real-time RT-PCR test on pooled samples for COVID-19 surveillance testing
title Validation and deployment of a direct saliva real-time RT-PCR test on pooled samples for COVID-19 surveillance testing
title_full Validation and deployment of a direct saliva real-time RT-PCR test on pooled samples for COVID-19 surveillance testing
title_fullStr Validation and deployment of a direct saliva real-time RT-PCR test on pooled samples for COVID-19 surveillance testing
title_full_unstemmed Validation and deployment of a direct saliva real-time RT-PCR test on pooled samples for COVID-19 surveillance testing
title_short Validation and deployment of a direct saliva real-time RT-PCR test on pooled samples for COVID-19 surveillance testing
title_sort validation and deployment of a direct saliva real-time rt-pcr test on pooled samples for covid-19 surveillance testing
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8718011/
https://www.ncbi.nlm.nih.gov/pubmed/34969053
http://dx.doi.org/10.1371/journal.pone.0261956
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