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Analytical Performance of Quantitative DiaSorin Liaison SARS-COV-2 Antigen Test for the Asymptomatic Population

Background: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antigen (Ag) tests have been widely employed to identify patients for a rapid diagnosis and pandemic control. Rapid lateral-flow techniques are currently the most used, but automated technologies have emerged as another viable...

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Autores principales: Fernández-Rivas, Gema, Barallat, Jaume, Gonzalez, Victoria, Martinez, Silvia, Bordoy, Antoni E., Jimenez, Laura, Casañ, Cristina, Blanco, Ignacio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8777041/
https://www.ncbi.nlm.nih.gov/pubmed/35071169
http://dx.doi.org/10.3389/fpubh.2021.788581
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author Fernández-Rivas, Gema
Barallat, Jaume
Gonzalez, Victoria
Martinez, Silvia
Bordoy, Antoni E.
Jimenez, Laura
Casañ, Cristina
Blanco, Ignacio
author_facet Fernández-Rivas, Gema
Barallat, Jaume
Gonzalez, Victoria
Martinez, Silvia
Bordoy, Antoni E.
Jimenez, Laura
Casañ, Cristina
Blanco, Ignacio
author_sort Fernández-Rivas, Gema
collection PubMed
description Background: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antigen (Ag) tests have been widely employed to identify patients for a rapid diagnosis and pandemic control. Rapid lateral-flow techniques are currently the most used, but automated technologies have emerged as another viable alternative to molecular methods. We aimed to evaluate the analytical performance of the DiaSorin Liaison SARS-CoV-2 Ag test in asymptomatic population and close contacts, for its use as a tool in pandemic control efforts. Material and Methods: A retrospective study was conducted. A total of 861 samples were included, 291 (34%) were positive for SARS-CoV-2 with cycle threshold (Ct) <40, and 570 (66%) were negative. Results: A strong correlation was observed between reverse transcriptase-PCR (RT-PCR) Ct and Ag 50% Tissue Culture Infectious Dose per milliliter (TCID(50)/ml; r = 0.6486; p < 0.0001) and all RT-PCR negative samples tested negative for the 200 TCID(50)/ml SARS-Cov-2 Ag cutoff, i.e., a specificity of 100% was reached (95% CI: 99.4–100.0%). Samples with <25 Ct and/or >10(6) extrapolated copies/ml were reached a sensitivity of 100% (95% IC 97.0–100.0%). For intermediate viral loads (>10(5) extrapolated copies/ml or <30 Ct), the sensitivity value still exceeded 80%. As with other Ag methods, samples between 30 and 40 Ct could not be detected with a reliable sensitivity. Conclusions: The LIAISON® SARS-CoV-2 Ag assay displays an acceptable sensitivity and a very high specificity that is useful for detecting the presence of SARS-CoV-2 in nasal swabs (NPS) of asymptomatic population or to regular monitoring of risk groups in controlled settings. Additionally, the flexibility in processing different samples and in the sampling preparation process makes this test an option for its use in high throughput laboratories. Automated tests may facilitate result reporting and yield consistent data, while avoiding some of the pitfalls of rapid lateral-flow techniques, such as observer variability.
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spelling pubmed-87770412022-01-22 Analytical Performance of Quantitative DiaSorin Liaison SARS-COV-2 Antigen Test for the Asymptomatic Population Fernández-Rivas, Gema Barallat, Jaume Gonzalez, Victoria Martinez, Silvia Bordoy, Antoni E. Jimenez, Laura Casañ, Cristina Blanco, Ignacio Front Public Health Public Health Background: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antigen (Ag) tests have been widely employed to identify patients for a rapid diagnosis and pandemic control. Rapid lateral-flow techniques are currently the most used, but automated technologies have emerged as another viable alternative to molecular methods. We aimed to evaluate the analytical performance of the DiaSorin Liaison SARS-CoV-2 Ag test in asymptomatic population and close contacts, for its use as a tool in pandemic control efforts. Material and Methods: A retrospective study was conducted. A total of 861 samples were included, 291 (34%) were positive for SARS-CoV-2 with cycle threshold (Ct) <40, and 570 (66%) were negative. Results: A strong correlation was observed between reverse transcriptase-PCR (RT-PCR) Ct and Ag 50% Tissue Culture Infectious Dose per milliliter (TCID(50)/ml; r = 0.6486; p < 0.0001) and all RT-PCR negative samples tested negative for the 200 TCID(50)/ml SARS-Cov-2 Ag cutoff, i.e., a specificity of 100% was reached (95% CI: 99.4–100.0%). Samples with <25 Ct and/or >10(6) extrapolated copies/ml were reached a sensitivity of 100% (95% IC 97.0–100.0%). For intermediate viral loads (>10(5) extrapolated copies/ml or <30 Ct), the sensitivity value still exceeded 80%. As with other Ag methods, samples between 30 and 40 Ct could not be detected with a reliable sensitivity. Conclusions: The LIAISON® SARS-CoV-2 Ag assay displays an acceptable sensitivity and a very high specificity that is useful for detecting the presence of SARS-CoV-2 in nasal swabs (NPS) of asymptomatic population or to regular monitoring of risk groups in controlled settings. Additionally, the flexibility in processing different samples and in the sampling preparation process makes this test an option for its use in high throughput laboratories. Automated tests may facilitate result reporting and yield consistent data, while avoiding some of the pitfalls of rapid lateral-flow techniques, such as observer variability. Frontiers Media S.A. 2022-01-07 /pmc/articles/PMC8777041/ /pubmed/35071169 http://dx.doi.org/10.3389/fpubh.2021.788581 Text en Copyright © 2022 Fernández-Rivas, Barallat, Gonzalez, Martinez, Bordoy, Jimenez, Casañ and Blanco. 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
Fernández-Rivas, Gema
Barallat, Jaume
Gonzalez, Victoria
Martinez, Silvia
Bordoy, Antoni E.
Jimenez, Laura
Casañ, Cristina
Blanco, Ignacio
Analytical Performance of Quantitative DiaSorin Liaison SARS-COV-2 Antigen Test for the Asymptomatic Population
title Analytical Performance of Quantitative DiaSorin Liaison SARS-COV-2 Antigen Test for the Asymptomatic Population
title_full Analytical Performance of Quantitative DiaSorin Liaison SARS-COV-2 Antigen Test for the Asymptomatic Population
title_fullStr Analytical Performance of Quantitative DiaSorin Liaison SARS-COV-2 Antigen Test for the Asymptomatic Population
title_full_unstemmed Analytical Performance of Quantitative DiaSorin Liaison SARS-COV-2 Antigen Test for the Asymptomatic Population
title_short Analytical Performance of Quantitative DiaSorin Liaison SARS-COV-2 Antigen Test for the Asymptomatic Population
title_sort analytical performance of quantitative diasorin liaison sars-cov-2 antigen test for the asymptomatic population
topic Public Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8777041/
https://www.ncbi.nlm.nih.gov/pubmed/35071169
http://dx.doi.org/10.3389/fpubh.2021.788581
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