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Evaluation of commercially available fully automated and ELISA-based assays for detecting anti-SARS-CoV-2 neutralizing antibodies.
Zedan, Hadeel T; Yassine, Hadi M; Al-Sadeq, Duaa W; Liu, Na; Qotba, Hamda; Nicolai, Eleonora; Pieri, Massimo; Bernardini, Sergio; Abu-Raddad, Laith J; Nasrallah, Gheyath K.
  • Zedan HT; Department of Biomedical Science, College of Health Sciences, QU Health, Qatar University, P.O. Box 2713, Doha, Qatar.
  • Yassine HM; Biomedical Research Center, Qatar University, P.O. Box 2713, Doha, Qatar.
  • Al-Sadeq DW; Department of Biomedical Science, College of Health Sciences, QU Health, Qatar University, P.O. Box 2713, Doha, Qatar. hyassine@qu.edu.qa.
  • Liu N; Biomedical Research Center, Qatar University, P.O. Box 2713, Doha, Qatar. hyassine@qu.edu.qa.
  • Qotba H; Biomedical Research Center, Qatar University, P.O. Box 2713, Doha, Qatar.
  • Nicolai E; College of Medicine, QU Health, Qatar University, P.O. Box 2713, Doha, Qatar.
  • Pieri M; Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, China.
  • Bernardini S; Department of Clinical Research, Primary Health Care Centers, Doha, Qatar.
  • Abu-Raddad LJ; Department of Experimental Medicine, University of Rome Tor Vergata, 00133, Rome, Italy.
  • Nasrallah GK; Department of Experimental Medicine, University of Rome Tor Vergata, 00133, Rome, Italy.
Sci Rep ; 12(1): 19020, 2022 Nov 08.
Article in English | MEDLINE | ID: covidwho-2106452
ABSTRACT
Rapid 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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Sci Rep Year: 2022 Document Type: Article Affiliation country: S41598-022-21317-x

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Sci Rep Year: 2022 Document Type: Article Affiliation country: S41598-022-21317-x