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    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

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    Date
    2022-08-01
    Author
    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 F.
    Ismail, Ahmed
    Abu-Raddad, Laith J.
    Nasrallah, Gheyath K.
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    Abstract
    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.
    URI
    https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85137406189&origin=inward
    DOI/handle
    http://dx.doi.org/10.3390/vaccines10081318
    http://hdl.handle.net/10576/37560
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    • Biomedical Research Center Research [‎537‎ items ]
    • Biomedical Sciences [‎451‎ items ]
    • Dental Medicine Research [‎166‎ items ]
    • Medicine Research [‎732‎ items ]

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