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AuthorYounes, Nadin
AuthorAl-Sadeq, Duaa W.
AuthorShurrab, Farah M.
AuthorZedan, Hadeel T.
AuthorAbou-Saleh, Haissam
AuthorAbo-Halawa, Bushra Y.
AuthorAlHamaydeh, Fatima M.
AuthorElsharafi, Amira E.
AuthorDaas, Hanin I.
AuthorThomas, Swapna
AuthorAboalmaaly, Sahar
AuthorAl Farsi, Afra
AuthorAl-Buainain, Reeham
AuthorAtaelmannan, Samar
AuthorPaul, Jiji
AuthorAl Saadi, Amana Salih
AuthorYassine, Hadi M.
AuthorMajdalawieh, Amin F.
AuthorIsmail, Ahmed
AuthorAbu-Raddad, Laith J.
AuthorNasrallah, Gheyath K.
Available date2022-12-25T09:04:31Z
Publication Date2022-08-01
Publication NameVaccines
Identifierhttp://dx.doi.org/10.3390/vaccines10081318
CitationYounes, 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.; Aboalmaaly, S.; Al Farsi, A.; Al-Buainain, R.; Ataelmannan, S.; Paul, J.; Al Saadi, A.S.; Yassine, H.M.; Majdalawieh, A.F.; Ismail, A.; Abu-Raddad, L.J.; Nasrallah, G.K. 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
URIhttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85137406189&origin=inward
URIhttp://hdl.handle.net/10576/37560
AbstractBackground: 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.
SponsorThis work was made possible by grant number UREP28-173-3-057 from the Qatar National Research Fund (a member of Qatar Foundation). The statements made herein are solely the responsibility of the authors.
Languageen
PublisherMDPI
Subjectautomated immunoassay
CLIA
COVID-19
lateral flow assay
neutralizing antibodies
SARS-CoV-2
serology
surrogate virus neutralization test (sVNT)
TitleValidation 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
TypeArticle
Issue Number8
Volume Number10
ESSN2076-393X
dc.accessType Open Access


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