Characterizing A “N-CoV-2-IgG PS” diagnostic kit to quantify SARS-CoV-2 nucleocapsid protein-specific human IgG antibodies
- Authors: Zueva E.V.1, Belyaev N.N.1, Verbov V.N.1, Likhachev I.V.1, Bachinin I.A.1, Khamitova I.V.1, Korobova Z.R.1,2, Arsentieva N.A.1, Totolian A.A.1,2
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Affiliations:
- St. Petersburg Pasteur Institute
- Pavlov First St. Petersburg State Medical University
- Issue: Vol 12, No 4 (2022)
- Pages: 771-778
- Section: SHORT COMMUNICATIONS
- URL: https://journals.rcsi.science/2220-7619/article/view/119127
- DOI: https://doi.org/10.15789/2220-7619-CAN-1904
- ID: 119127
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Abstract
Confirming detected SARS-CoV-2-specific antibodies is necessary to reveal immune response in COVID-19 convalescent subjects as well as to conduct population studies by screening for specific antibodies to assess rate of COVID-19 prevalence. With this purpose St. Petersburg Pasteur Institute was the first in Russia to develop the ELISA kit for the quantitative determination of human IgG to the SARS-CoV-2 nucleocapsid (N-CoV-2-IgG PS). Arbitrary units (AU/ml) were used to assess the level of antibodies. The data shown in AU/ml were recalculated later to the international units (BAU/ml) in accordance with established the First WHO International Standard for anti-SARS-CoV-2 human Immunoglobulin. Comparing the data of the N-CoV-2-IgG PS calibration curve with those of the First WHO International Standard for anti-SARS-CoV-2 human Immunoglobulin revealed a complete inter-assay association (r = 0.999, R2 = 0.997) allowing to find that 1BAU/ml = 5.97 AU/ml. The aim of the study was to characterize the “SARS-CoV-2 protein N Human IgG Quantitative ELISA Kit” (N-CoV-2-IgG PS), compare quantitative and qualitative data of ELISA kits, assess a correlation between the binding antibodies to SARS-CoV-2 N proteins and the neutralizing antibodies against SARS-CoV-2. The data of correlation analysis of the 83 COVID-19 convalescent blood plasma samples a significant relationship between the antibodies quantitative values and titers SARS-CoV-2-specific antibody (r = 0.8436, R2 = 0.7802) as well as a moderate relationship between antibody concentration and positivity index (r = 0.6648, R2 = 0.3307), assessed by Chaddock scale. Comparing concentration of N-protein binding antibodies with neutralizing antibody titers level uncovered data consistency obtained by quantitative and virus microneutralization assays (r = 0.7310, R2 = 0.6527) used in parallel to analyze 80 blood plasma samples obtained from COVID-19 patients and convalescents. AUC under the ROC curve comprised 0.701 (P < 0.0001) evidencing about a satisfactory informative value for “N-CoV-2-IgG PS” compared with microneutralization assay. In addition, the efficacy of the “N-CoV-2-IgG PS” was 95%, while the positive and negative prognostic value was 97% and 87%, respectively. The data obtained confirmed a correlation between N-protein binding antibody level and neutralizing antibody titer. Checking inter-assay agreement evidenced about acceptance for informativeness and efficacy of using “N-CoV-2-IgG PS”, thereby confirming an opportunity to apply the Kit to screen for SARS-CoV-2 N protein-specific IgG antibody level and assess seroprevalence in diverse population cohorts.
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##article.viewOnOriginalSite##About the authors
Elena V. Zueva
St. Petersburg Pasteur Institute
Author for correspondence.
Email: elenazueva9@gmail.com
PhD (Biology), Senior Researcher, Laboratory of Molecular Immunology
Russian Federation, 14, Mira str., St. Petersburg, 197101Nikolai N. Belyaev
St. Petersburg Pasteur Institute
Email: nikobel@gmail.com
PhD, MD (Biology), Senior Researcher, Department of New Technologies
Russian Federation, 14, Mira str., St. Petersburg, 197101Vyacheslav N. Verbov
St. Petersburg Pasteur Institute
Email: verbov@pasteurorg.ru
PhD (Chemistry), Head of the Laboratory of Biological Products, Head of the Department of New Technologies
Russian Federation, 14, Mira str., St. Petersburg, 197101Ivan V. Likhachev
St. Petersburg Pasteur Institute
Email: liv-dnt@mail.ru
Junior Researcher, Laboratory of Biological Products
Russian Federation, 14, Mira str., St. Petersburg, 197101Igor A. Bachinin
St. Petersburg Pasteur Institute
Email: bachinini@mail.ru
Pilot Industrial Production Technologist
Russian Federation, 14, Mira str., St. Petersburg, 197101Irina V. Khamitova
St. Petersburg Pasteur Institute
Email: div-o@mail.ru
PhD (Biology), Head of the Central Сlinical Diagnostic Laboratory
Russian Federation, 14, Mira str., St. Petersburg, 197101Zoya R. Korobova
St. Petersburg Pasteur Institute; Pavlov First St. Petersburg State Medical University
Email: zoia-korobova@yandex.ru
Investigator (Biologist), Laboratory of Molecular Immunology, Senior Laboratory Assistant, Department of Immunology
Russian Federation, 14, Mira str., St. Petersburg, 197101; St. PetersburgNatalya A. Arsentieva
St. Petersburg Pasteur Institute
Email: arsentieva_n.a@bk.ru
PhD (Biology), Senior Researcher, Laboratory of Molecular Immunology
Russian Federation, 14, Mira str., St. Petersburg, 197101Areg A. Totolian
St. Petersburg Pasteur Institute; Pavlov First St. Petersburg State Medical University
Email: totolian@spbraaci.ru
Member, PhD, MD (Medicine), Professor, Director, Head of the Department of Immunology
Russian Federation, 14, Mira str., St. Petersburg, 197101; St. PetersburgReferences
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