Validation of a Novel Fluorescent Lateral Flow Assay for Rapid Qualitative and Quantitative Assessment of Total Anti-SARS-CoV-2 S-RBD Binding Antibody Units (BAU) from Plasma or Fingerstick Whole-Blood of COVID-19 Vaccinees
Background: Limited commercial LFA assays are available to provide a reliable quantitative measurement of the total binding antibody units (BAU/mL) against the receptor-binding domain of the SARS-CoV-2 spike protein (S-RBD). Aim: This study aimed to evaluate the performance of the fluorescence LFA F...
محفوظ في:
| المؤلف الرئيسي: | |
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| مؤلفون آخرون: | , , , , , , , , , , , , , , , , , , , |
| التنسيق: | article |
| منشور في: |
2022
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| الموضوعات: | |
| الوصول للمادة أونلاين: | http://hdl.handle.net/11073/25040 |
| الوسوم: |
إضافة وسم
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| _version_ | 1864513436251062272 |
|---|---|
| author | Younes, Nadin |
| author2 | Al-Sadeq, Duaa W. Shurrab, Farah M. Zedan, Hadeel T. Abou-Saleh, Haissam Abo-Halawa, Bushra Y. AlHamaydeh, Fatima M. Elsharafi, Amira E. Daas, Hanin I. Thomas, Swapna Aboalmaaly, Sahar Al Farsi, Afra Al-Buainain, Reeham Ataelmannan, Samar Paul, Jiji Al Saadi, Amana Salih Yassine, Hadi M. Majdalawieh, Amin Ismail, Ahmed Abu-Raddad, Laith J. Nasrallah, Gheyath K. |
| author2_role | author author author author author author author author author author author author author author author author author author author author |
| author_facet | Younes, Nadin Al-Sadeq, Duaa W. Shurrab, Farah M. Zedan, Hadeel T. Abou-Saleh, Haissam Abo-Halawa, Bushra Y. AlHamaydeh, Fatima M. Elsharafi, Amira E. Daas, Hanin I. Thomas, Swapna Aboalmaaly, Sahar Al Farsi, Afra Al-Buainain, Reeham Ataelmannan, Samar Paul, Jiji Al Saadi, Amana Salih Yassine, Hadi M. Majdalawieh, Amin Ismail, Ahmed Abu-Raddad, Laith J. Nasrallah, Gheyath K. |
| author_role | author |
| dc.creator.none.fl_str_mv | Younes, Nadin Al-Sadeq, Duaa W. Shurrab, Farah M. Zedan, Hadeel T. Abou-Saleh, Haissam Abo-Halawa, Bushra Y. AlHamaydeh, Fatima M. Elsharafi, Amira E. Daas, Hanin I. Thomas, Swapna Aboalmaaly, Sahar Al Farsi, Afra Al-Buainain, Reeham Ataelmannan, Samar Paul, Jiji Al Saadi, Amana Salih Yassine, Hadi M. Majdalawieh, Amin Ismail, Ahmed Abu-Raddad, Laith J. Nasrallah, Gheyath K. |
| dc.date.none.fl_str_mv | 2022-10-24T05:15:45Z 2022-10-24T05:15:45Z 2022 |
| dc.format.none.fl_str_mv | application/pdf |
| dc.identifier.none.fl_str_mv | Younes, N.; Al-Sadeq, D.W.; Shurrab, F.M.; Zedan, H.T.; Abou-Saleh, H.; Abo-Halawa, B.Y.; AlHamaydeh, F.M.; Elsharafi, A.E.; Daas, H.I.; Thomas, S.; et al. Validation of a Novel Fluorescent Lateral Flow Assay for Rapid Qualitative and Quantitative Assessment of Total Anti-SARS-CoV-2 S-RBD Binding Antibody Units (BAU) from Plasma or Fingerstick Whole-Blood of COVID-19 Vaccinees. Vaccines 2022, 10, 1318. https://doi.org/10.3390/vaccines10081318 2076-393X http://hdl.handle.net/11073/25040 10.3390/vaccines10081318 |
| dc.language.none.fl_str_mv | en_US |
| dc.publisher.none.fl_str_mv | MDPI |
| dc.relation.none.fl_str_mv | https://doi.org/10.3390/vaccines10081318 |
| dc.subject.none.fl_str_mv | SARS-CoV-2 COVID-19 serology Lateral flow assay Automated immunoassay CLIA Neutralizing antibodies Surrogate virus neutralization test (sVNT) |
| dc.title.none.fl_str_mv | Validation of a Novel Fluorescent Lateral Flow Assay for Rapid Qualitative and Quantitative Assessment of Total Anti-SARS-CoV-2 S-RBD Binding Antibody Units (BAU) from Plasma or Fingerstick Whole-Blood of COVID-19 Vaccinees |
| dc.type.none.fl_str_mv | Peer-Reviewed Published version info:eu-repo/semantics/publishedVersion info:eu-repo/semantics/article |
| description | Background: Limited commercial LFA assays are available to provide a reliable quantitative measurement of the total binding antibody units (BAU/mL) against the receptor-binding domain of the SARS-CoV-2 spike protein (S-RBD). Aim: This study aimed to evaluate the performance of the fluorescence LFA FinecareTM 2019-nCoV S-RBD test along with its reader (Model No.: FS-113) against the following reference methods: (i) the FDA-approved GenScript surrogate virus-neutralizing assay (sVNT); and (ii) three highly performing automated immunoassays: BioMérieux VIDAS®3, Ortho VITROS®, and Mindray CL-900i®. Methods: Plasma from 488 vaccinees was tested by all aforementioned assays. Fingerstick whole-blood samples from 156 vaccinees were also tested by FinecareTM. Results and conclusions: FinecareTM showed 100% specificity, as none of the pre-pandemic samples tested positive. Equivalent FinecareTM results were observed among the samples taken from fingerstick or plasma (Pearson correlation r = 0.9, p < 0.0001), suggesting that fingerstick samples are sufficient to quantitate the S-RBD BAU/mL. A moderate correlation was observed between FinecareTM and sVNT (r = 0.5, p < 0.0001), indicating that FinecareTM can be used for rapid prediction of the neutralizing antibody (nAb) post-vaccination. FinecareTM BAU results showed strong correlation with VIDAS®3 (r = 0.6, p < 0.0001) and moderate correlation with VITROS® (r = 0.5, p < 0.0001) and CL-900i® (r = 0.4, p < 0.0001), suggesting that FinecareTM can be used as a surrogate for the advanced automated assays to measure S-RBD BAU/mL. |
| format | article |
| id | aus_99c520189faca5cda714ba42fb63b9b6 |
| identifier_str_mv | Younes, N.; Al-Sadeq, D.W.; Shurrab, F.M.; Zedan, H.T.; Abou-Saleh, H.; Abo-Halawa, B.Y.; AlHamaydeh, F.M.; Elsharafi, A.E.; Daas, H.I.; Thomas, S.; et al. Validation of a Novel Fluorescent Lateral Flow Assay for Rapid Qualitative and Quantitative Assessment of Total Anti-SARS-CoV-2 S-RBD Binding Antibody Units (BAU) from Plasma or Fingerstick Whole-Blood of COVID-19 Vaccinees. Vaccines 2022, 10, 1318. https://doi.org/10.3390/vaccines10081318 2076-393X 10.3390/vaccines10081318 |
| language_invalid_str_mv | en_US |
| network_acronym_str | aus |
| network_name_str | aus |
| oai_identifier_str | oai:repository.aus.edu:11073/25040 |
| publishDate | 2022 |
| publisher.none.fl_str_mv | MDPI |
| repository.mail.fl_str_mv | |
| repository.name.fl_str_mv | |
| repository_id_str | |
| spelling | Validation of a Novel Fluorescent Lateral Flow Assay for Rapid Qualitative and Quantitative Assessment of Total Anti-SARS-CoV-2 S-RBD Binding Antibody Units (BAU) from Plasma or Fingerstick Whole-Blood of COVID-19 VaccineesYounes, NadinAl-Sadeq, Duaa W.Shurrab, Farah M.Zedan, Hadeel T.Abou-Saleh, HaissamAbo-Halawa, Bushra Y.AlHamaydeh, Fatima M.Elsharafi, Amira E.Daas, Hanin I.Thomas, SwapnaAboalmaaly, SaharAl Farsi, AfraAl-Buainain, ReehamAtaelmannan, SamarPaul, JijiAl Saadi, Amana SalihYassine, Hadi M.Majdalawieh, AminIsmail, AhmedAbu-Raddad, Laith J.Nasrallah, Gheyath K.SARS-CoV-2COVID-19serologyLateral flow assayAutomated immunoassayCLIANeutralizing antibodiesSurrogate virus neutralization test (sVNT)Background: Limited commercial LFA assays are available to provide a reliable quantitative measurement of the total binding antibody units (BAU/mL) against the receptor-binding domain of the SARS-CoV-2 spike protein (S-RBD). Aim: This study aimed to evaluate the performance of the fluorescence LFA FinecareTM 2019-nCoV S-RBD test along with its reader (Model No.: FS-113) against the following reference methods: (i) the FDA-approved GenScript surrogate virus-neutralizing assay (sVNT); and (ii) three highly performing automated immunoassays: BioMérieux VIDAS®3, Ortho VITROS®, and Mindray CL-900i®. Methods: Plasma from 488 vaccinees was tested by all aforementioned assays. Fingerstick whole-blood samples from 156 vaccinees were also tested by FinecareTM. Results and conclusions: FinecareTM showed 100% specificity, as none of the pre-pandemic samples tested positive. Equivalent FinecareTM results were observed among the samples taken from fingerstick or plasma (Pearson correlation r = 0.9, p < 0.0001), suggesting that fingerstick samples are sufficient to quantitate the S-RBD BAU/mL. A moderate correlation was observed between FinecareTM and sVNT (r = 0.5, p < 0.0001), indicating that FinecareTM can be used for rapid prediction of the neutralizing antibody (nAb) post-vaccination. FinecareTM BAU results showed strong correlation with VIDAS®3 (r = 0.6, p < 0.0001) and moderate correlation with VITROS® (r = 0.5, p < 0.0001) and CL-900i® (r = 0.4, p < 0.0001), suggesting that FinecareTM can be used as a surrogate for the advanced automated assays to measure S-RBD BAU/mL.Qatar National Research FundMDPI2022-10-24T05:15:45Z2022-10-24T05:15:45Z2022Peer-ReviewedPublished versioninfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfYounes, N.; Al-Sadeq, D.W.; Shurrab, F.M.; Zedan, H.T.; Abou-Saleh, H.; Abo-Halawa, B.Y.; AlHamaydeh, F.M.; Elsharafi, A.E.; Daas, H.I.; Thomas, S.; et al. Validation of a Novel Fluorescent Lateral Flow Assay for Rapid Qualitative and Quantitative Assessment of Total Anti-SARS-CoV-2 S-RBD Binding Antibody Units (BAU) from Plasma or Fingerstick Whole-Blood of COVID-19 Vaccinees. Vaccines 2022, 10, 1318. https://doi.org/10.3390/vaccines100813182076-393Xhttp://hdl.handle.net/11073/2504010.3390/vaccines10081318en_UShttps://doi.org/10.3390/vaccines10081318oai:repository.aus.edu:11073/250402024-08-22T11:59:50Z |
| spellingShingle | Validation of a Novel Fluorescent Lateral Flow Assay for Rapid Qualitative and Quantitative Assessment of Total Anti-SARS-CoV-2 S-RBD Binding Antibody Units (BAU) from Plasma or Fingerstick Whole-Blood of COVID-19 Vaccinees Younes, Nadin SARS-CoV-2 COVID-19 serology Lateral flow assay Automated immunoassay CLIA Neutralizing antibodies Surrogate virus neutralization test (sVNT) |
| status_str | publishedVersion |
| title | Validation of a Novel Fluorescent Lateral Flow Assay for Rapid Qualitative and Quantitative Assessment of Total Anti-SARS-CoV-2 S-RBD Binding Antibody Units (BAU) from Plasma or Fingerstick Whole-Blood of COVID-19 Vaccinees |
| title_full | Validation of a Novel Fluorescent Lateral Flow Assay for Rapid Qualitative and Quantitative Assessment of Total Anti-SARS-CoV-2 S-RBD Binding Antibody Units (BAU) from Plasma or Fingerstick Whole-Blood of COVID-19 Vaccinees |
| title_fullStr | Validation of a Novel Fluorescent Lateral Flow Assay for Rapid Qualitative and Quantitative Assessment of Total Anti-SARS-CoV-2 S-RBD Binding Antibody Units (BAU) from Plasma or Fingerstick Whole-Blood of COVID-19 Vaccinees |
| title_full_unstemmed | Validation of a Novel Fluorescent Lateral Flow Assay for Rapid Qualitative and Quantitative Assessment of Total Anti-SARS-CoV-2 S-RBD Binding Antibody Units (BAU) from Plasma or Fingerstick Whole-Blood of COVID-19 Vaccinees |
| title_short | Validation of a Novel Fluorescent Lateral Flow Assay for Rapid Qualitative and Quantitative Assessment of Total Anti-SARS-CoV-2 S-RBD Binding Antibody Units (BAU) from Plasma or Fingerstick Whole-Blood of COVID-19 Vaccinees |
| title_sort | Validation of a Novel Fluorescent Lateral Flow Assay for Rapid Qualitative and Quantitative Assessment of Total Anti-SARS-CoV-2 S-RBD Binding Antibody Units (BAU) from Plasma or Fingerstick Whole-Blood of COVID-19 Vaccinees |
| topic | SARS-CoV-2 COVID-19 serology Lateral flow assay Automated immunoassay CLIA Neutralizing antibodies Surrogate virus neutralization test (sVNT) |
| url | http://hdl.handle.net/11073/25040 |