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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

Vaccines (Basel). 2022-08; 
Nadin Younes, Duaa W Al-Sadeq, Farah M Shurrab, Hadeel T Zedan, Haissam Abou-Saleh, Bushra Y Abo-Halawa, Fatima M AlHamaydeh, Amira E Elsharafi, Hanin I Daas, Swapna Thomas, Sahar Aboalmaaly, Afra Al Farsi, Reeham Al-Buainain, Samar Ataelmannan, Jiji Paul, Amana Salih Al Saadi, Hadi M Yassine, Amin F Majdalawieh, Ahmed Ismail, Laith J Abu-Raddad, Gheyath K Nasrallah
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摘要

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). 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 VIDAS3, Ortho VITROS, and Mindray CL-900i. Plasma from 488 vaccinees was tested by all aforementioned assays. Fingerstick whole-blood samples from 156 vaccinees were also tested ... More

关键词

CLIA, COVID-19, SARS-CoV-2, automated immunoassay, lateral flow assay, neutralizing antibodies, serology, surrogate virus neutralization test (sVNT)
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