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
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
Affiliations
Nadin Younes
Biomedical Research Center, Qatar University, Doha 2713, Qatar
Duaa W. Al-Sadeq
Biomedical Research Center, Qatar University, Doha 2713, Qatar
Farah M. Shurrab
Biomedical Research Center, Qatar University, Doha 2713, Qatar
Hadeel T. Zedan
Biomedical Research Center, Qatar University, Doha 2713, Qatar
Haissam Abou-Saleh
Biomedical Research Center, Qatar University, Doha 2713, Qatar
Bushra Y. Abo-Halawa
Biological Science Program, Department of Biological and Environmental Sciences, College of Arts and Sciences, Qatar University, Doha, 2713, Qatar
Fatima M. AlHamaydeh
Department of Biomedical Science, College of Health Sciences, QU Health, Qatar University, Doha 2713, Qatar
Amira E. Elsharafi
Department of Biomedical Science, College of Health Sciences, QU Health, Qatar University, Doha 2713, Qatar
Hanin I. Daas
College of Dental Medicine, QU Health, Qatar University, Doha 2713, Qatar
Swapna Thomas
Biomedical Research Center, Qatar University, Doha 2713, Qatar
Sahar Aboalmaaly
Laboratory Section, Medical Commission Department, Ministry of Public Health, Doha 42, Qatar
Afra Al Farsi
Laboratory Section, Medical Commission Department, Ministry of Public Health, Doha 42, Qatar
Reeham Al-Buainain
Laboratory Section, Medical Commission Department, Ministry of Public Health, Doha 42, Qatar
Samar Ataelmannan
Laboratory Section, Medical Commission Department, Ministry of Public Health, Doha 42, Qatar
Jiji Paul
Laboratory Section, Medical Commission Department, Ministry of Public Health, Doha 42, Qatar
Amana Salih Al Saadi
Laboratory Section, Medical Commission Department, Ministry of Public Health, Doha 42, Qatar
Hadi M. Yassine
Biomedical Research Center, Qatar University, Doha 2713, Qatar
Amin F. Majdalawieh
Department of Biology, Chemistry and Environmental Sciences, College of Arts and Sciences, American University of Sharjah, Sharjah 26666, United Arab Emirates
Ahmed Ismail
Laboratory Section, Medical Commission Department, Ministry of Public Health, Doha 42, Qatar
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 r = 0.5, p ®3 (r = 0.6, p ® (r = 0.5, p ® (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.
