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AuthorZedan, Hadeel T.
AuthorYassine, Hadi M.
AuthorAl-Sadeq, Duaa W.
AuthorLiu, Na
AuthorQotba, Hamda
AuthorNicolai, Eleonora
AuthorPieri, Massimo
AuthorBernardini, Sergio
AuthorAbu-Raddad, Laith J.
AuthorNasrallah, Gheyath K.
Available date2022-12-22T08:20:29Z
Publication Date2022-12-01
Publication NameScientific Reports
Identifierhttp://dx.doi.org/10.1038/s41598-022-21317-x
CitationZedan, H.T., Yassine, H.M., Al-Sadeq, D.W. et al. Evaluation of commercially available fully automated and ELISA-based assays for detecting anti-SARS-CoV-2 neutralizing antibodies. Sci Rep 12, 19020 (2022). https://doi.org/10.1038/s41598-022-21317-x
URIhttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85141613744&origin=inward
URIhttp://hdl.handle.net/10576/37543
AbstractRapid and accurate measurement of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)-specific neutralizing antibodies (nAbs) is paramount for monitoring immunity in infected and vaccinated subjects. The current gold standard relies on pseudovirus neutralization tests which require sophisticated skills and facilities. Alternatively, recent competitive immunoassays measuring anti-SARS-CoV-2 nAbs are proposed as a quick and commercially available surrogate virus neutralization test (sVNT). Here, we report the performance evaluation of three sVNTs, including two ELISA-based assays and an automated bead-based immunoassay for detecting nAbs against SARS-CoV-2. The performance of three sVNTs, including GenScript cPass, Dynamiker, and Mindray NTAb was assessed in samples collected from SARS-CoV-2 infected patients (n = 160), COVID-19 vaccinated individuals (n = 163), and pre-pandemic controls (n = 70). Samples were collected from infected patients and vaccinated individuals 2–24 weeks after symptoms onset or second dose administration. Correlation analysis with pseudovirus neutralization test (pVNT) and immunoassays detecting anti-SARS-CoV-2 binding antibodies was performed. Receiver operating characteristic (ROC) curve analysis was generated to assess the optimal threshold for detecting nAbs by each assay. All three sVNTs showed an excellent performance in terms of specificity (100%) and sensitivity (100%, 97.0%, and 97.1% for GenScript, Dynamiker, and Mindray, respectively) in samples collected from vaccinated subjects. GenScript demonstrated the strongest correlation with pVNT (r = 0.743, R2 = 0.552), followed by Mindray (r = 0.718, R2 = 0.515) and Dynamiker (r = 0.608, R2 = 0.369). Correlation with anti-SARS-CoV-2 binding antibodies was variable, but the strongest correlations were observed between anti-RBD IgG antibodies and Mindray (r = 0.952, R2 = 0.907). ROC curve analyses demonstrated excellent performance for all three sVNT assays in both groups, with an AUC ranging between 0.99 and 1.0 (p < 0.0001). Also, it was shown that the manufacturer's recommended cutoff values could be modified based on the tested cohort without significantly affecting the sVNT performance. The sVNT provides a rapid, low-cost, and scalable alternative to conventional neutralization assays for measuring and expanding nAbs testing across various research and clinical settings. Also, it could aid in evaluating actual protective immunity at the population level and assessing vaccine effectiveness to lay a foundation for boosters' requirements.
SponsorFunding was provided by Qatar Foundation (Grant number: UREP28-173-3-057), Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, China, Qatar University (Grant number: RRC-2-032).
Languageen
PublisherNature Research
SubjectImmunological techniques
Immunology
TitleEvaluation of commercially available fully automated and ELISA-based assays for detecting anti-SARS-CoV-2 neutralizing antibodies
TypeArticle
Issue Number1
Volume Number12
ESSN2045-2322
dc.accessType Open Access


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