Performance evaluation of novel fluorescent-based lateral flow immunoassay (LFIA) for rapid detection and quantification of total anti-SARS-CoV-2 S-RBD binding antibodies in infected individuals
<h3>Background</h3><p dir="ltr">A vast majority of the commercially available lateral flow immunoassay (LFIA) is used to detect SARS-CoV-2 antibodies qualitatively. Recently, a novel fluorescence-based lateral flow immunoassay (LFIA) test was developed for quantitative me...
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2022
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| _version_ | 1864513512347271168 |
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| author | Farah M. Shurrab (16324961) |
| author2 | Nadin Younes (4863280) Duaa W. Al-Sadeq (10976754) Na Liu (102929) Hamda Qotba (12794976) Laith J. Abu-Raddad (9262524) Gheyath K. Nasrallah (9200525) |
| author2_role | author author author author author author |
| author_facet | Farah M. Shurrab (16324961) Nadin Younes (4863280) Duaa W. Al-Sadeq (10976754) Na Liu (102929) Hamda Qotba (12794976) Laith J. Abu-Raddad (9262524) Gheyath K. Nasrallah (9200525) |
| author_role | author |
| dc.creator.none.fl_str_mv | Farah M. Shurrab (16324961) Nadin Younes (4863280) Duaa W. Al-Sadeq (10976754) Na Liu (102929) Hamda Qotba (12794976) Laith J. Abu-Raddad (9262524) Gheyath K. Nasrallah (9200525) |
| dc.date.none.fl_str_mv | 2022-05-01T00:00:00Z |
| dc.identifier.none.fl_str_mv | 10.1016/j.ijid.2022.02.052 |
| dc.relation.none.fl_str_mv | https://figshare.com/articles/journal_contribution/Performance_evaluation_of_novel_fluorescent-based_lateral_flow_immunoassay_LFIA_for_rapid_detection_and_quantification_of_total_anti-SARS-CoV-2_S-RBD_binding_antibodies_in_infected_individuals/26095450 |
| 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 Cardiovascular medicine and haematology Clinical sciences Health sciences Public health SARS-CoV-2 COVID-19 Serology Lateral Flow Assay Fluorescence immunoassay |
| dc.title.none.fl_str_mv | Performance evaluation of novel fluorescent-based lateral flow immunoassay (LFIA) for rapid detection and quantification of total anti-SARS-CoV-2 S-RBD binding antibodies in infected individuals |
| dc.type.none.fl_str_mv | Text Journal contribution info:eu-repo/semantics/publishedVersion text contribution to journal |
| description | <h3>Background</h3><p dir="ltr">A vast majority of the commercially available lateral flow immunoassay (LFIA) is used to detect SARS-CoV-2 antibodies qualitatively. Recently, a novel fluorescence-based lateral flow immunoassay (LFIA) test was developed for quantitative measurement of the total binding antibody units (BAUs) (BAU/mL) against SARS-CoV-2 spike protein receptor-binding domain (S-RBD).</p><h3>Aim</h3><p dir="ltr">This study aimed to evaluate the performance of the fluorescence LFIA Finecare<sup>TM</sup> 2019-nCoV S-RBD test along with its reader (Model No.: FS-113).</p><h3>Methods</h3><p dir="ltr">Plasma from 150 reverse trancriptase–PCR (RT-PCR)-confirmed positive individuals and 100 prepandemic samples were tested by Fincare<sup>TM</sup> to access sensitivity and specificity. For qualitative and quantitative validation of the FinCare<sup>TM</sup> measurements, BAU/mL results of FinCare<sup>TM</sup> were compared with results of 2 reference assays: the surrogate virus-neutralizing test (sVNT, GenScript Biotech, USA) and the VIDAS®3 automated assay (BioMérieux, France).</p><h3>Results</h3><p dir="ltr">Finecare<sup>TM</sup> showed 92% sensitivity and 100% specificity compared with PCR. Cohen's Kappa statistic denoted moderate and excellent agreement with sVNT and VIDAS®3, with values being 0.557 (95% CI: 0.32–0.78) and 0.731 (95% CI: 0.51–0.95), respectively. A strong correlation was observed between Finecare<sup>TM</sup>/sVNT (r = 0.7, p < 0.0001) and Finecare<sup>TM/</sup>VIDAS®3 (r = 0.8, p < 0.0001).</p><h3>Conclusion</h3><p dir="ltr">Finecare<sup>TM</sup> is a reliable assay and can be used as a surrogate to assess binding and neutralizing antibody response after infection or vaccination, particularly in none or small laboratory settings.</p><h2>Other Information</h2><p dir="ltr">Published in: International Journal of Infectious Diseases<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="https://dx.doi.org/10.1016/j.ijid.2022.02.052" target="_blank">https://dx.doi.org/10.1016/j.ijid.2022.02.052</a></p> |
| eu_rights_str_mv | openAccess |
| id | Manara2_01d15fa6537d370d267e3ea557745e1e |
| identifier_str_mv | 10.1016/j.ijid.2022.02.052 |
| network_acronym_str | Manara2 |
| network_name_str | Manara2 |
| oai_identifier_str | oai:figshare.com:article/26095450 |
| publishDate | 2022 |
| repository.mail.fl_str_mv | |
| repository.name.fl_str_mv | |
| repository_id_str | |
| rights_invalid_str_mv | CC BY 4.0 |
| spelling | Performance evaluation of novel fluorescent-based lateral flow immunoassay (LFIA) for rapid detection and quantification of total anti-SARS-CoV-2 S-RBD binding antibodies in infected individualsFarah M. Shurrab (16324961)Nadin Younes (4863280)Duaa W. Al-Sadeq (10976754)Na Liu (102929)Hamda Qotba (12794976)Laith J. Abu-Raddad (9262524)Gheyath K. Nasrallah (9200525)Biomedical and clinical sciencesCardiovascular medicine and haematologyClinical sciencesHealth sciencesPublic healthSARS-CoV-2COVID-19SerologyLateral Flow AssayFluorescence immunoassay<h3>Background</h3><p dir="ltr">A vast majority of the commercially available lateral flow immunoassay (LFIA) is used to detect SARS-CoV-2 antibodies qualitatively. Recently, a novel fluorescence-based lateral flow immunoassay (LFIA) test was developed for quantitative measurement of the total binding antibody units (BAUs) (BAU/mL) against SARS-CoV-2 spike protein receptor-binding domain (S-RBD).</p><h3>Aim</h3><p dir="ltr">This study aimed to evaluate the performance of the fluorescence LFIA Finecare<sup>TM</sup> 2019-nCoV S-RBD test along with its reader (Model No.: FS-113).</p><h3>Methods</h3><p dir="ltr">Plasma from 150 reverse trancriptase–PCR (RT-PCR)-confirmed positive individuals and 100 prepandemic samples were tested by Fincare<sup>TM</sup> to access sensitivity and specificity. For qualitative and quantitative validation of the FinCare<sup>TM</sup> measurements, BAU/mL results of FinCare<sup>TM</sup> were compared with results of 2 reference assays: the surrogate virus-neutralizing test (sVNT, GenScript Biotech, USA) and the VIDAS®3 automated assay (BioMérieux, France).</p><h3>Results</h3><p dir="ltr">Finecare<sup>TM</sup> showed 92% sensitivity and 100% specificity compared with PCR. Cohen's Kappa statistic denoted moderate and excellent agreement with sVNT and VIDAS®3, with values being 0.557 (95% CI: 0.32–0.78) and 0.731 (95% CI: 0.51–0.95), respectively. A strong correlation was observed between Finecare<sup>TM</sup>/sVNT (r = 0.7, p < 0.0001) and Finecare<sup>TM/</sup>VIDAS®3 (r = 0.8, p < 0.0001).</p><h3>Conclusion</h3><p dir="ltr">Finecare<sup>TM</sup> is a reliable assay and can be used as a surrogate to assess binding and neutralizing antibody response after infection or vaccination, particularly in none or small laboratory settings.</p><h2>Other Information</h2><p dir="ltr">Published in: International Journal of Infectious Diseases<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="https://dx.doi.org/10.1016/j.ijid.2022.02.052" target="_blank">https://dx.doi.org/10.1016/j.ijid.2022.02.052</a></p>2022-05-01T00:00:00ZTextJournal contributioninfo:eu-repo/semantics/publishedVersiontextcontribution to journal10.1016/j.ijid.2022.02.052https://figshare.com/articles/journal_contribution/Performance_evaluation_of_novel_fluorescent-based_lateral_flow_immunoassay_LFIA_for_rapid_detection_and_quantification_of_total_anti-SARS-CoV-2_S-RBD_binding_antibodies_in_infected_individuals/26095450CC BY 4.0info:eu-repo/semantics/openAccessoai:figshare.com:article/260954502022-05-01T00:00:00Z |
| spellingShingle | Performance evaluation of novel fluorescent-based lateral flow immunoassay (LFIA) for rapid detection and quantification of total anti-SARS-CoV-2 S-RBD binding antibodies in infected individuals Farah M. Shurrab (16324961) Biomedical and clinical sciences Cardiovascular medicine and haematology Clinical sciences Health sciences Public health SARS-CoV-2 COVID-19 Serology Lateral Flow Assay Fluorescence immunoassay |
| status_str | publishedVersion |
| title | Performance evaluation of novel fluorescent-based lateral flow immunoassay (LFIA) for rapid detection and quantification of total anti-SARS-CoV-2 S-RBD binding antibodies in infected individuals |
| title_full | Performance evaluation of novel fluorescent-based lateral flow immunoassay (LFIA) for rapid detection and quantification of total anti-SARS-CoV-2 S-RBD binding antibodies in infected individuals |
| title_fullStr | Performance evaluation of novel fluorescent-based lateral flow immunoassay (LFIA) for rapid detection and quantification of total anti-SARS-CoV-2 S-RBD binding antibodies in infected individuals |
| title_full_unstemmed | Performance evaluation of novel fluorescent-based lateral flow immunoassay (LFIA) for rapid detection and quantification of total anti-SARS-CoV-2 S-RBD binding antibodies in infected individuals |
| title_short | Performance evaluation of novel fluorescent-based lateral flow immunoassay (LFIA) for rapid detection and quantification of total anti-SARS-CoV-2 S-RBD binding antibodies in infected individuals |
| title_sort | Performance evaluation of novel fluorescent-based lateral flow immunoassay (LFIA) for rapid detection and quantification of total anti-SARS-CoV-2 S-RBD binding antibodies in infected individuals |
| topic | Biomedical and clinical sciences Cardiovascular medicine and haematology Clinical sciences Health sciences Public health SARS-CoV-2 COVID-19 Serology Lateral Flow Assay Fluorescence immunoassay |