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Analysis of seven SARS-CoV-2 rapid antigen tests in detecting omicron (B.1.1.529) versus delta (B.1.617.2) using cell culture supernatants and clinical specimens

PURPOSE: Omicron is rapidly spreading as a new SARS-CoV-2 variant of concern (VOC). The question whether this new variant has an impact on SARS-CoV-2 rapid antigen test (RAT) performance is of utmost importance. To obtain an initial estimate regarding differences of RATs in detecting omicron and del...

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Autores principales: Jungnick, Sabrina, Hobmaier, Bernhard, Paravinja, Natali, Mautner, Lena, Hoyos, Mona, Konrad, Regina, Haase, Maren, Baiker, Armin, Eberle, Ute, Bichler, Magdalena, Treis, Bianca, Okeyo, Mercy, Streibl, Barbara, Wimmer, Clara, Hepner, Sabrina, Sprenger, Annika, Berger, Carola, Weise, Laura, Dangel, Alexandra, Ippisch, Siegfried, Jonas, Walter, Wildner, Manfred, Liebl, Bernhard, Ackermann, Nikolaus, Sing, Andreas, Fingerle, Volker
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9122478/
https://www.ncbi.nlm.nih.gov/pubmed/35596057
http://dx.doi.org/10.1007/s15010-022-01844-5
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author Jungnick, Sabrina
Hobmaier, Bernhard
Paravinja, Natali
Mautner, Lena
Hoyos, Mona
Konrad, Regina
Haase, Maren
Baiker, Armin
Eberle, Ute
Bichler, Magdalena
Treis, Bianca
Okeyo, Mercy
Streibl, Barbara
Wimmer, Clara
Hepner, Sabrina
Sprenger, Annika
Berger, Carola
Weise, Laura
Dangel, Alexandra
Ippisch, Siegfried
Jonas, Walter
Wildner, Manfred
Liebl, Bernhard
Ackermann, Nikolaus
Sing, Andreas
Fingerle, Volker
author_facet Jungnick, Sabrina
Hobmaier, Bernhard
Paravinja, Natali
Mautner, Lena
Hoyos, Mona
Konrad, Regina
Haase, Maren
Baiker, Armin
Eberle, Ute
Bichler, Magdalena
Treis, Bianca
Okeyo, Mercy
Streibl, Barbara
Wimmer, Clara
Hepner, Sabrina
Sprenger, Annika
Berger, Carola
Weise, Laura
Dangel, Alexandra
Ippisch, Siegfried
Jonas, Walter
Wildner, Manfred
Liebl, Bernhard
Ackermann, Nikolaus
Sing, Andreas
Fingerle, Volker
author_sort Jungnick, Sabrina
collection PubMed
description PURPOSE: Omicron is rapidly spreading as a new SARS-CoV-2 variant of concern (VOC). The question whether this new variant has an impact on SARS-CoV-2 rapid antigen test (RAT) performance is of utmost importance. To obtain an initial estimate regarding differences of RATs in detecting omicron and delta, seven commonly used SARS-CoV-2 RATs from different manufacturers were analysed using cell culture supernatants and clinical specimens. METHODS: For this purpose, cell culture-expanded omicron and delta preparations were serially diluted in Dulbecco’s modified Eagle’s Medium (DMEM) and the Limit of Detection (LoD) for both VOCs was determined. Additionally, clinical specimens stored in viral transport media or saline (n = 51) were investigated to complement in vitro results with cell culture supernatants. Ct values and RNA concentrations were determined via quantitative reverse transcription polymerase chain reaction (RT-qPCR). RESULTS: The in vitro determination of the LoD showed no obvious differences in detection of omicron and delta for the RATs examined. The LoD in this study was at a dilution level of 1:1,000 (corresponding to 3.0—5.6 × 10(6) RNA copies/mL) for tests I–V and at a dilution level of 1:100 (corresponding to 3.7—4.9 × 10(7) RNA copies/mL) for tests VI and VII. Based on clinical specimens, no obvious differences were observed between RAT positivity rates when comparing omicron to delta in this study setting. Overall positivity rates varied between manufacturers with 30–81% for omicron and 42–71% for delta. Test VII was only conducted in vitro with cell culture supernatants for feasibility reasons. In the range of Ct < 23, positivity rates were 50–100% for omicron and 67–93% for delta. CONCLUSION: In this study, RATs from various manufacturers were investigated, which displayed no obvious differences in terms of analytical LoD in vitro and RAT positivity rates based on clinical samples comparing the VOCs omicron and delta. However, differences between tests produced by various manufacturers were detected. In terms of clinical samples, a focus of this study was on specimens with high virus concentrations. Further systematic, clinical and laboratory studies utilizing large datasets are urgently needed to confirm reliable performance in terms of sensitivity and specificity for all individual RATs and SARS-CoV-2 variants. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s15010-022-01844-5.
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spelling pubmed-91224782022-05-21 Analysis of seven SARS-CoV-2 rapid antigen tests in detecting omicron (B.1.1.529) versus delta (B.1.617.2) using cell culture supernatants and clinical specimens Jungnick, Sabrina Hobmaier, Bernhard Paravinja, Natali Mautner, Lena Hoyos, Mona Konrad, Regina Haase, Maren Baiker, Armin Eberle, Ute Bichler, Magdalena Treis, Bianca Okeyo, Mercy Streibl, Barbara Wimmer, Clara Hepner, Sabrina Sprenger, Annika Berger, Carola Weise, Laura Dangel, Alexandra Ippisch, Siegfried Jonas, Walter Wildner, Manfred Liebl, Bernhard Ackermann, Nikolaus Sing, Andreas Fingerle, Volker Infection Brief Report PURPOSE: Omicron is rapidly spreading as a new SARS-CoV-2 variant of concern (VOC). The question whether this new variant has an impact on SARS-CoV-2 rapid antigen test (RAT) performance is of utmost importance. To obtain an initial estimate regarding differences of RATs in detecting omicron and delta, seven commonly used SARS-CoV-2 RATs from different manufacturers were analysed using cell culture supernatants and clinical specimens. METHODS: For this purpose, cell culture-expanded omicron and delta preparations were serially diluted in Dulbecco’s modified Eagle’s Medium (DMEM) and the Limit of Detection (LoD) for both VOCs was determined. Additionally, clinical specimens stored in viral transport media or saline (n = 51) were investigated to complement in vitro results with cell culture supernatants. Ct values and RNA concentrations were determined via quantitative reverse transcription polymerase chain reaction (RT-qPCR). RESULTS: The in vitro determination of the LoD showed no obvious differences in detection of omicron and delta for the RATs examined. The LoD in this study was at a dilution level of 1:1,000 (corresponding to 3.0—5.6 × 10(6) RNA copies/mL) for tests I–V and at a dilution level of 1:100 (corresponding to 3.7—4.9 × 10(7) RNA copies/mL) for tests VI and VII. Based on clinical specimens, no obvious differences were observed between RAT positivity rates when comparing omicron to delta in this study setting. Overall positivity rates varied between manufacturers with 30–81% for omicron and 42–71% for delta. Test VII was only conducted in vitro with cell culture supernatants for feasibility reasons. In the range of Ct < 23, positivity rates were 50–100% for omicron and 67–93% for delta. CONCLUSION: In this study, RATs from various manufacturers were investigated, which displayed no obvious differences in terms of analytical LoD in vitro and RAT positivity rates based on clinical samples comparing the VOCs omicron and delta. However, differences between tests produced by various manufacturers were detected. In terms of clinical samples, a focus of this study was on specimens with high virus concentrations. Further systematic, clinical and laboratory studies utilizing large datasets are urgently needed to confirm reliable performance in terms of sensitivity and specificity for all individual RATs and SARS-CoV-2 variants. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s15010-022-01844-5. Springer Berlin Heidelberg 2022-05-20 2023 /pmc/articles/PMC9122478/ /pubmed/35596057 http://dx.doi.org/10.1007/s15010-022-01844-5 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Brief Report
Jungnick, Sabrina
Hobmaier, Bernhard
Paravinja, Natali
Mautner, Lena
Hoyos, Mona
Konrad, Regina
Haase, Maren
Baiker, Armin
Eberle, Ute
Bichler, Magdalena
Treis, Bianca
Okeyo, Mercy
Streibl, Barbara
Wimmer, Clara
Hepner, Sabrina
Sprenger, Annika
Berger, Carola
Weise, Laura
Dangel, Alexandra
Ippisch, Siegfried
Jonas, Walter
Wildner, Manfred
Liebl, Bernhard
Ackermann, Nikolaus
Sing, Andreas
Fingerle, Volker
Analysis of seven SARS-CoV-2 rapid antigen tests in detecting omicron (B.1.1.529) versus delta (B.1.617.2) using cell culture supernatants and clinical specimens
title Analysis of seven SARS-CoV-2 rapid antigen tests in detecting omicron (B.1.1.529) versus delta (B.1.617.2) using cell culture supernatants and clinical specimens
title_full Analysis of seven SARS-CoV-2 rapid antigen tests in detecting omicron (B.1.1.529) versus delta (B.1.617.2) using cell culture supernatants and clinical specimens
title_fullStr Analysis of seven SARS-CoV-2 rapid antigen tests in detecting omicron (B.1.1.529) versus delta (B.1.617.2) using cell culture supernatants and clinical specimens
title_full_unstemmed Analysis of seven SARS-CoV-2 rapid antigen tests in detecting omicron (B.1.1.529) versus delta (B.1.617.2) using cell culture supernatants and clinical specimens
title_short Analysis of seven SARS-CoV-2 rapid antigen tests in detecting omicron (B.1.1.529) versus delta (B.1.617.2) using cell culture supernatants and clinical specimens
title_sort analysis of seven sars-cov-2 rapid antigen tests in detecting omicron (b.1.1.529) versus delta (b.1.617.2) using cell culture supernatants and clinical specimens
topic Brief Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9122478/
https://www.ncbi.nlm.nih.gov/pubmed/35596057
http://dx.doi.org/10.1007/s15010-022-01844-5
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