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

<p dir="ltr">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...

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Main Author: Gheyath K. Nasrallah (2182598) (author)
Other Authors: Fatma Ali (16328920) (author), Salma Younes (6424865) (author), Heba A. Al-Khatib (16328921) (author), Asmaa A. AlThani (16328924) (author), Hadi M. Yassine (16328940) (author)
Published: 2023
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author Gheyath K. Nasrallah (2182598)
author2 Fatma Ali (16328920)
Salma Younes (6424865)
Heba A. Al-Khatib (16328921)
Asmaa A. AlThani (16328924)
Hadi M. Yassine (16328940)
author2_role author
author
author
author
author
author_facet Gheyath K. Nasrallah (2182598)
Fatma Ali (16328920)
Salma Younes (6424865)
Heba A. Al-Khatib (16328921)
Asmaa A. AlThani (16328924)
Hadi M. Yassine (16328940)
author_role author
dc.creator.none.fl_str_mv Gheyath K. Nasrallah (2182598)
Fatma Ali (16328920)
Salma Younes (6424865)
Heba A. Al-Khatib (16328921)
Asmaa A. AlThani (16328924)
Hadi M. Yassine (16328940)
dc.date.none.fl_str_mv 2023-06-10T00:00:00Z
dc.identifier.none.fl_str_mv 10.1016/j.heliyon.2023.e17179
dc.relation.none.fl_str_mv https://figshare.com/articles/preprint/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/23514462
dc.rights.none.fl_str_mv CC BY 4.0
info:eu-repo/semantics/openAccess
dc.subject.none.fl_str_mv Biomedical and clinical sciences
Medical microbiology
Health sciences
Epidemiology
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 Text
Preprint
info:eu-repo/semantics/publishedVersion
text
preprint
description <p dir="ltr">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.</p><h2>Other Information</h2><p dir="ltr">Published in: Heliyon<br>License: <a href="http://creativecommons.org/licenses/by/4.0/" target="_blank">http://creativecommons.org/licenses/by/4.0/</a><br>See article on publisher's website: <a href="http://dx.doi.org/10.1016/j.heliyon.2023.e17179" target="_blank">http://dx.doi.org/10.1016/j.heliyon.2023.e17179</a></p>
eu_rights_str_mv openAccess
id Manara2_974cbfc857a8059d79d146ca0ba09309
identifier_str_mv 10.1016/j.heliyon.2023.e17179
network_acronym_str Manara2
network_name_str Manara2
oai_identifier_str oai:figshare.com:article/23514462
publishDate 2023
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rights_invalid_str_mv CC 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. Nasrallah (2182598)Fatma Ali (16328920)Salma Younes (6424865)Heba A. Al-Khatib (16328921)Asmaa A. AlThani (16328924)Hadi M. Yassine (16328940)Biomedical and clinical sciencesMedical microbiologyHealth sciencesEpidemiologyRADTSARS-CoV-2COVID-19Lateral flowImmunofluorescence<p dir="ltr">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.</p><h2>Other Information</h2><p dir="ltr">Published in: Heliyon<br>License: <a href="http://creativecommons.org/licenses/by/4.0/" target="_blank">http://creativecommons.org/licenses/by/4.0/</a><br>See article on publisher's website: <a href="http://dx.doi.org/10.1016/j.heliyon.2023.e17179" target="_blank">http://dx.doi.org/10.1016/j.heliyon.2023.e17179</a></p>2023-06-10T00:00:00ZTextPreprintinfo:eu-repo/semantics/publishedVersiontextpreprint10.1016/j.heliyon.2023.e17179https://figshare.com/articles/preprint/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/23514462CC BY 4.0info:eu-repo/semantics/openAccessoai:figshare.com:article/235144622023-06-10T00:00:00Z
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 (2182598)
Biomedical and clinical sciences
Medical microbiology
Health sciences
Epidemiology
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 Biomedical and clinical sciences
Medical microbiology
Health sciences
Epidemiology
RADT
SARS-CoV-2
COVID-19
Lateral flow
Immunofluorescence