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Performance of the rapid high-throughput automated electrochemiluminescence immunoassay targeting total antibodies to the SARS-CoV-2 spike protein receptor binding domain in comparison to the neutralization assay.
Resman Rus, Katarina; Korva, Misa; Knap, Natasa; Avsic Zupanc, Tatjana; Poljak, Mario.
  • Resman Rus K; Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Zaloska 4, 1000 Ljubljana, Slovenia.
  • Korva M; Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Zaloska 4, 1000 Ljubljana, Slovenia.
  • Knap N; Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Zaloska 4, 1000 Ljubljana, Slovenia.
  • Avsic Zupanc T; Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Zaloska 4, 1000 Ljubljana, Slovenia.
  • Poljak M; Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Zaloska 4, 1000 Ljubljana, Slovenia. Electronic address: mario.poljak@mf.uni-lj.si.
J Clin Virol ; 139: 104820, 2021 06.
Article in English | MEDLINE | ID: covidwho-1174355
ABSTRACT

BACKGROUND:

Neutralization tests (NT) are the gold standard for detecting and quantifying anti-SARS-CoV-2 neutralizing antibodies (NAb), but their complexity restricts them to research settings or reference laboratories. Antibodies against S protein receptor binding domain (RBD) have been shown to confer a neutralizing activity against SARS-CoV-2. Assays quantitatively measuring anti-S1-RBD-SARS-CoV-2 antibodies could be of great value for NAb screening of potential donors for convalescent-phase plasma therapy, assessing natural or vaccine-induced immunity, stratifying individuals for vaccine receipt, and documenting vaccine response.

METHODS:

Elecsys Anti-SARS-CoV-2 S (Elecsys-S), a high-throughput automated electrochemiluminescence double-antigen sandwich immunoassay for quantitative measurement of pan-anti-S1-RBD-SARS-CoV-2 antibodies, was evaluated against NT on 357 patients with PCR-confirmed SARS-CoV-2 infection. NT was performed in a BSL-3 laboratory using a Slovenian SARS-CoV-2 isolate; the NT titer ≥120 was considered positive.

RESULTS:

Elecsys-S detected pan-anti-S1-RBD-SARS-CoV-2 antibodies in 352/357 (98.6 %) samples. NAb were identified by NT in 257/357 (72 %) samples. The Elecsys-S/NT agreement was moderate (Cohen's kappa 0.56). High NT titer antibodies (≥1160) were detected in 106/357 (30 %) samples. Elecsys-S's pan-anti-S1-RBD-SARS-CoV-2 antibody concentrations correlated with individual NT titer categories (the lowest concentrations were identified in NT-negative samples and the highest in samples with NT titer 11,280), and the Elecsys-S cutoff value for reasonable prediction of NAb generated after natural infection was established (133 BAU/mL).

CONCLUSION:

Although NT should remain the gold standard for assessing candidates for convalescent-phase plasma donors, selected commercial anti-SARS-CoV-2 assays with optimized cutoff, like Elecsys-S, could be used for rapid, automated, and large-scale screening of individuals with clinically relevant NAb levels as suitable donors.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoassay / Neutralization Tests / Spike Glycoprotein, Coronavirus / COVID-19 / Luminescent Measurements / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: J Clin Virol Journal subject: Virology Year: 2021 Document Type: Article Affiliation country: J.jcv.2021.104820

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoassay / Neutralization Tests / Spike Glycoprotein, Coronavirus / COVID-19 / Luminescent Measurements / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: J Clin Virol Journal subject: Virology Year: 2021 Document Type: Article Affiliation country: J.jcv.2021.104820