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A Novel Quantitative Multi-Component Serological Assay for SARS-CoV-2 Vaccine Evaluation.
Fisher, Morly; Manor, Alon; Abramovitch, Hagar; Fatelevich, Ella; Afrimov, Yafa; Bilinsky, Gal; Lupu, Edith; Ben-Shmuel, Amir; Glinert, Itai; Madar-Balakirski, Noa; Marcus, Hadar; Mechaly, Adva.
  • Fisher M; Department of Infectious Diseases, Israel Institute for Biological Research, 7410001 Ness-Ziona, Israel.
  • Manor A; Department of Environmental Physics, Israel Institute for Biological Research, 7410001 Ness Ziona, Israel.
  • Abramovitch H; Department of Quality Assurance, Israel Institute for Biological Research, 7410001 Ness Ziona, Israel.
  • Fatelevich E; Department of Infectious Diseases, Israel Institute for Biological Research, 7410001 Ness-Ziona, Israel.
  • Afrimov Y; Department of Infectious Diseases, Israel Institute for Biological Research, 7410001 Ness-Ziona, Israel.
  • Bilinsky G; Department of Biochemistry and Molecular Genetics, Israel Institute for Biological Research, 7410001 Ness Ziona, Israel.
  • Lupu E; Department of Biotechnology, Israel Institute for Biological Research, 7410001 Ness Ziona, Israel.
  • Ben-Shmuel A; Department of Infectious Diseases, Israel Institute for Biological Research, 7410001 Ness-Ziona, Israel.
  • Glinert I; Department of Infectious Diseases, Israel Institute for Biological Research, 7410001 Ness-Ziona, Israel.
  • Madar-Balakirski N; Department of Pharmacology, Israel Institute for Biological Research, 7410001 Ness Ziona, Israel.
  • Marcus H; Department of Biotechnology, Israel Institute for Biological Research, 7410001 Ness Ziona, Israel.
  • Mechaly A; Department of Infectious Diseases, Israel Institute for Biological Research, 7410001 Ness-Ziona, Israel.
Anal Chem ; 94(10): 4380-4389, 2022 03 15.
Article in English | MEDLINE | ID: covidwho-1713090
ABSTRACT
A multi-component microarray, applying a novel analysis algorithm, was developed for quantitative evaluation of the SARS-CoV-2 vaccines' immunogenicity. The array enables simultaneous quantitation of IgG, IgM, and IgA, specific to the SARS-CoV-2 spike, receptor binding domain, and nucleocapsid proteins. The developed methodology is based on calculating an apparent immunoglobulin signal from the linear range of the fluorescent read-outs generated by scanning the microarray slides at different exposure times. A dedicated algorithm, employing a rigorous set of embedded conditions, then generates a normalized signal for each of the unique assays. Qualification of the multi-component array performance (evaluating linearity, extended dynamic-range, specificity, precision, and accuracy) was carried out with an in-house COVID-19, qRT-PCR positive serum, as well as pre-pandemic commercial negative sera. Results were compared to the WHO international standard for anti-SARS-CoV-2 immunoglobulins. Specific IgG, IgM, and IgA signals obtained by this array enabled successful discrimination between SARS-CoV-2 q-RT-PCR positive (seroconverted SARS-CoV-2 patients) and negative (naïve) samples. This array is currently used for evaluation of the humoral response to BriLife, the VSV-based Israeli vaccine during phase I/II clinical trials.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Anal Chem Year: 2022 Document Type: Article Affiliation country: Acs.analchem.1c05264

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Anal Chem Year: 2022 Document Type: Article Affiliation country: Acs.analchem.1c05264