Enhancing the sensitivity of rapid antigen detection test (RADT) of different SARS-CoV-2 variants and lineages using fluorescence-labeled antibodies and a fluorescent meter

RT-qPCR is considered the gold standard for diagnosis of COVID-19; however, it is laborious, time-consuming, and expensive. RADTs have evolved recently as relatively inexpensive methods to address these shortcomings, but their performance for detecting different SARS-COV-2 variants remains limited....

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Main Author: Gheyath K., Nasrallah (author)
Other Authors: Ali, Fatma (author), Younes, Salma (author), Al Khatib, Heba A. (author), Al-Thani, Asmaa A. (author), Yassine, Hadi M. (author)
Format: article
Published: 2023
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Online Access:http://dx.doi.org/10.1016/j.heliyon.2023.e17179
https://www.sciencedirect.com/science/article/pii/S2405844023043876
http://hdl.handle.net/10576/47982
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author Gheyath K., Nasrallah
author2 Ali, Fatma
Younes, Salma
Al Khatib, Heba A.
Al-Thani, Asmaa A.
Yassine, Hadi M.
author2_role author
author
author
author
author
author_facet Gheyath K., Nasrallah
Ali, Fatma
Younes, Salma
Al Khatib, Heba A.
Al-Thani, Asmaa A.
Yassine, Hadi M.
author_role author
dc.creator.none.fl_str_mv Gheyath K., Nasrallah
Ali, Fatma
Younes, Salma
Al Khatib, Heba A.
Al-Thani, Asmaa A.
Yassine, Hadi M.
dc.date.none.fl_str_mv 2023-09-26T10:44:59Z
2023-06-30
dc.format.none.fl_str_mv application/pdf
dc.identifier.none.fl_str_mv http://dx.doi.org/10.1016/j.heliyon.2023.e17179
24058440
https://www.sciencedirect.com/science/article/pii/S2405844023043876
http://hdl.handle.net/10576/47982
6
9
dc.language.none.fl_str_mv en
dc.publisher.none.fl_str_mv Elsevier
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
dc.subject.none.fl_str_mv RADT
SARS-CoV-2
COVID-19
Lateral flow
Immunofluorescence
dc.title.none.fl_str_mv Enhancing the sensitivity of rapid antigen detection test (RADT) of different SARS-CoV-2 variants and lineages using fluorescence-labeled antibodies and a fluorescent meter
dc.type.none.fl_str_mv Article
info:eu-repo/semantics/publishedVersion
info:eu-repo/semantics/article
description RT-qPCR is considered the gold standard for diagnosis of COVID-19; however, it is laborious, time-consuming, and expensive. RADTs have evolved recently as relatively inexpensive methods to address these shortcomings, but their performance for detecting different SARS-COV-2 variants remains limited. RADT test performance could be enhanced using different antibody labeling and signal detection techniques. Here, we aimed to evaluate the performance of two antigen RADTs for detecting different SARS-CoV-2 variants: (i) the conventional colorimetric RADT (Ab-conjugated with gold beads); and (ii) the new Finecare™ RADT (Ab-coated fluorescent beads). Finecare™ is a meter used for the detection of a fluorescent signal. 187 frozen nasopharyngeal swabs collected in Universal transport (UTM) that are RT-qPCR positive for different SARS-CoV-2 variants were selected, including Alpha (n = 60), Delta (n = 59), and Omicron variants (n = 108). Sixty flu and 60 RSV-positive samples were included as negative controls (total sample number = 347). The conventional RADT showed sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 62.4% (95%CI: 54–70), 100% (95%CI: 97–100), 100% (95%CI: 100-100), and 58% (95%CI: 49–67), respectively. These measurements were enhanced using the Finecare™ RADT: sensitivity, specificity, PPV, and NPV were 92.6% (95%CI: 89.08–92.3), 96% (95%CI: 96–99.61), 98% (95%CI: 89–92.3), and 85% (95%CI: 96–99.6) respectively. The sensitivity of both RADTs could be greatly underestimated because nasopharyngeal swab samples collected UTM and stored at −80 °C were used. Despite that, our results indicate that the Finecare™ RADT is appropriate for clinical laboratory and community-based surveillance due to its high sensitivity and specificity.
eu_rights_str_mv openAccess
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language_invalid_str_mv en
network_acronym_str qu
network_name_str Qatar University repository
oai_identifier_str oai:qspace.qu.edu.qa:10576/47982
publishDate 2023
publisher.none.fl_str_mv Elsevier
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rights_invalid_str_mv http://creativecommons.org/licenses/by/4.0/
spelling Enhancing the sensitivity of rapid antigen detection test (RADT) of different SARS-CoV-2 variants and lineages using fluorescence-labeled antibodies and a fluorescent meterGheyath K., NasrallahAli, FatmaYounes, SalmaAl Khatib, Heba A.Al-Thani, Asmaa A.Yassine, Hadi M.RADTSARS-CoV-2COVID-19Lateral flowImmunofluorescenceRT-qPCR is considered the gold standard for diagnosis of COVID-19; however, it is laborious, time-consuming, and expensive. RADTs have evolved recently as relatively inexpensive methods to address these shortcomings, but their performance for detecting different SARS-COV-2 variants remains limited. RADT test performance could be enhanced using different antibody labeling and signal detection techniques. Here, we aimed to evaluate the performance of two antigen RADTs for detecting different SARS-CoV-2 variants: (i) the conventional colorimetric RADT (Ab-conjugated with gold beads); and (ii) the new Finecare™ RADT (Ab-coated fluorescent beads). Finecare™ is a meter used for the detection of a fluorescent signal. 187 frozen nasopharyngeal swabs collected in Universal transport (UTM) that are RT-qPCR positive for different SARS-CoV-2 variants were selected, including Alpha (n = 60), Delta (n = 59), and Omicron variants (n = 108). Sixty flu and 60 RSV-positive samples were included as negative controls (total sample number = 347). The conventional RADT showed sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 62.4% (95%CI: 54–70), 100% (95%CI: 97–100), 100% (95%CI: 100-100), and 58% (95%CI: 49–67), respectively. These measurements were enhanced using the Finecare™ RADT: sensitivity, specificity, PPV, and NPV were 92.6% (95%CI: 89.08–92.3), 96% (95%CI: 96–99.61), 98% (95%CI: 89–92.3), and 85% (95%CI: 96–99.6) respectively. The sensitivity of both RADTs could be greatly underestimated because nasopharyngeal swab samples collected UTM and stored at −80 °C were used. Despite that, our results indicate that the Finecare™ RADT is appropriate for clinical laboratory and community-based surveillance due to its high sensitivity and specificity.This work was made possible by partial funds from REP29-026-3-004 grant from the Qatar National Research Fund (a member of Qatar Foundation) AND QUCG-BRC-2022/23-578 . The statements made herein are solely the responsibility of the authors. We thank the many dedicated persons at Hamad Medical Corporation, Sidra Medicine, and the National Reference lab for their diligent efforts and contributions to making this study possible. Open Access funding provided by the Qatar National Library.Elsevier2023-09-26T10:44:59Z2023-06-30Articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://dx.doi.org/10.1016/j.heliyon.2023.e1717924058440https://www.sciencedirect.com/science/article/pii/S2405844023043876http://hdl.handle.net/10576/4798269enhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:qspace.qu.edu.qa:10576/479822024-07-23T15:51:34Z
spellingShingle Enhancing the sensitivity of rapid antigen detection test (RADT) of different SARS-CoV-2 variants and lineages using fluorescence-labeled antibodies and a fluorescent meter
Gheyath K., Nasrallah
RADT
SARS-CoV-2
COVID-19
Lateral flow
Immunofluorescence
status_str publishedVersion
title Enhancing the sensitivity of rapid antigen detection test (RADT) of different SARS-CoV-2 variants and lineages using fluorescence-labeled antibodies and a fluorescent meter
title_full Enhancing the sensitivity of rapid antigen detection test (RADT) of different SARS-CoV-2 variants and lineages using fluorescence-labeled antibodies and a fluorescent meter
title_fullStr Enhancing the sensitivity of rapid antigen detection test (RADT) of different SARS-CoV-2 variants and lineages using fluorescence-labeled antibodies and a fluorescent meter
title_full_unstemmed Enhancing the sensitivity of rapid antigen detection test (RADT) of different SARS-CoV-2 variants and lineages using fluorescence-labeled antibodies and a fluorescent meter
title_short Enhancing the sensitivity of rapid antigen detection test (RADT) of different SARS-CoV-2 variants and lineages using fluorescence-labeled antibodies and a fluorescent meter
title_sort Enhancing the sensitivity of rapid antigen detection test (RADT) of different SARS-CoV-2 variants and lineages using fluorescence-labeled antibodies and a fluorescent meter
topic RADT
SARS-CoV-2
COVID-19
Lateral flow
Immunofluorescence
url http://dx.doi.org/10.1016/j.heliyon.2023.e17179
https://www.sciencedirect.com/science/article/pii/S2405844023043876
http://hdl.handle.net/10576/47982